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Author Topic: bionic assassins- T-cell killer  (Read 6760 times)

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Offline brazilianman

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bionic assassins- T-cell killer
« on: September 11, 2009, 02:09:34 PM »
FOR ALL

I sent e-mail to Adaptimmune and getting those answers.
I think the test will be in ai E.U.
Maybe someone wants to apply.

question:

hello. I really enjoyed the material on T-cell killer.
and the same design Adaptimmune?
has already been tested in rats or monkeys?
when will be tested in humans?
it will pass the blood-brain barrier (BBB)?
he would be able to find HIV / cell in Sleep?
in 2009 there will be testing in humans?
thanks. sorry bad ingles.


one reply:
The enhanced HIV TCR T-cells are being applied in clinical trials at the University of Pennsylvania under the auspices of Professor Carl June. I think these trials began recently but I cannot comment as I am not directly involved.

Andy

two reply:
Thanks for your email. Your timing is great. We hope this trial will be open in about 4 weeks, so we’re close. I’ll keep your email on hand. But also, please email me again in about 3 weeks for an update.

 

Cheers, Karen

http://www.newscientist.com/article/dn15156-pimped-up-tcells-seek-out-and-destroy-hiv.html?feedId=online-news_rss20


http://www.aidsmeds.com/articles/hiv_engineered_cd8_1667_15598.shtml 



« Last Edit: January 13, 2014, 12:25:59 PM by Jeff G »

Offline georgep77

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Re: bionic assassins- T-cell killer
« Reply #1 on: September 11, 2009, 02:29:33 PM »
Thanks for the info brazilianman !!
Come on Sangamo,  Geovax,  Bionor immuno, ...Make us happy !!!
+ 2008

Offline brazilianman

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  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #2 on: September 12, 2009, 08:17:40 AM »
hello
I sent an e-mail to dr. carl june.
I am awaiting response.
who wants to do the same?
who wants to call him?
a link Brazil / E.U. cost much.
lol

hello. I really enjoyed the material on T-cell killer.
1)and the same design Adaptimmune?
2)has already been tested in rats or monkeys?
3)when will be tested in humans?
4)it will pass the blood-brain barrier (BBB)?
5)he would be able to find HIV / cell in Sleep?
6)in 2009 there will be testing in humans?

 ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D ;D

554 Biomedical Rsch Bldg (BRB) II / III
421 Curie Boulevard 421 Curie Boulevard
Philadelphia, PA 19104-6160 Philadelphia, PA 19104-6160



« Last Edit: January 13, 2014, 12:27:10 PM by Jeff G »

Offline brazilianman

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Re: bionic assassins- T-cell killer
« Reply #3 on: September 15, 2009, 08:08:02 AM »
reply e-mail  adaptimmune

Dear bman
 
Thank you for getting in touch and your interest in the Adaptimmune technology.  Because the technology relies on a person’s own T cells (i.e. human cells) it is very difficult to test usefully in animals in early testing due to rejection of the cells.  It is possible, however, to do some testing in certain sorts of mice  and this is what we have been able to do along with many laboratory tests on human cells to provide the necessary data for the regulatory authorities to be happy to proceed for clinical testing in patients.  We are hoping to start our first clinical trial in HIV patients in the US very soon (before the end of 2009) and yes we are hopeful that the activated T cells should be able to find HIV-infected cells even when the virus is controlled and present at very low levels.
 
I hope this is useful and would like to thank you again for your interest in the technology.
 
Yours sincerely
 


Helen Tayton-Martin PhD MBA
Chief Operating Officer



 ;D

Offline veritas

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Re: bionic assassins- T-cell killer
« Reply #4 on: September 15, 2009, 08:47:42 AM »

bman,

This technology looks promising! The only question that needs a definitive answer is: Will these engineered T-cells only attack HIV infected cells and not attack the body? The trials will answer that question fairly quickly I believe. Here is somemore background:

http://www.adaptimmune.com/research-development/

Hopefully they will be able to incorporate this tech in a less expensive way, since it requires taking T-cells from an infected patient and re-programming them to do the job.

Neat stuff!

v

Offline brazilianman

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  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #5 on: September 16, 2009, 09:44:10 AM »
veritas

as the lifetime of a  lymphocyte t relp is short to verify its functionality quickly.
the price.
all done on a large scale where the low value.
Another interesting part is that these modified lymphocytes can help to apredear normal lymphocytes to hunt in a similar fashion.

good days are ahead

Offline brazilianman

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  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #6 on: September 16, 2009, 08:29:06 PM »
I was looking for and found the lifetime of a  lymphocyte cd8.
how long life has a lymphocytes CD8 T help?  ???
anyone know? ???

Offline brazilianman

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Re: bionic assassins- T-cell killer
« Reply #7 on: September 18, 2009, 05:16:08 PM »
a little more information

Dear bman,
    Thank you for your interest in Immunocore and Adaptimmune.  I'm happy to say that both companies approaches work well in vivo.  Adaptimmune will be starting its first clinical trial in the next few weeks and Immunocore will be starting a phase I cancer trial next year.  Immunocore is aiming to publish its recent work in a high impact journal towards the end of the year.
Kind regards,
 
Steve
 
Dr Stephen Megit
Senior Manager, Business Development
 


Dear Mr bman
 
We have not yet published the work in mice as this was just completed for the submission to the regulatory authorities.
 
As the programmes take off we will hopefully update our website with all relevant information.
 
Best regards
 


« Last Edit: January 13, 2014, 12:05:18 PM by Jeff G »

Offline Inchlingblue

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Re: bionic assassins- T-cell killer
« Reply #8 on: September 18, 2009, 06:20:23 PM »
Thanks for the update brazilianman.

I tried finding info on the lifecycle of a CD8 cell and could not. You might want to search using the word "apoptosis," which basically means when a cell dies naturally.

Offline veritas

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Re: bionic assassins- T-cell killer
« Reply #9 on: September 19, 2009, 08:02:58 PM »

bman,

Here's what I found concerning CD8 cells. Unfortunately, the answer isn't clearcut. Anywhere from years to less than a day.



"The lifespan of terminally differentiated cells can vary quite dramatically from relatively long-lived fates, such as neurons or Ab-secreting plasma cells that live for many years, to short-lived fates, such as neutrophils, intestinal villi, or epidermal skin cells that live for a few hours, days, or weeks, respectively. What properties distinguish terminally differentiated CD8 T cells and how this process influences memory CD8 T cell development are important questions to understand. "






http://www.jimmunol.org/cgi/content/full/180/3/1309

(Technical stuff)

v

Offline brazilianman

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  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #10 on: September 28, 2009, 12:40:37 PM »
NEWS CARL JUNE

Cell-based therapies with various lymphocyte subsets hold promise for the treatment of several diseases, including cancer and disease resulting from inflammation and infection. The ability to genetically engineer lymphocyte subsets has the potential to improve the natural immune response and correct impaired immunity. In this Review we focus on the lymphocyte subsets that have been modified genetically or by other means for therapeutic benefit, on the technologies used to engineer lymphocytes and on the latest progress and hurdles in translating these technologies to the clinic.

http://www.nature.com/nri/journal/v9/n10/abs/nri2635.html

Offline brazilianman

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Re: bionic assassins- T-cell killer
« Reply #11 on: October 07, 2009, 04:12:47 PM »
For immediate release:
Wednesday, October 7, 2009
 
Engineered T cell receptor trial opens with new cellular therapy for HIV
First- ever clinical trial with engineered T cells designed to clear HIV infection
 
PHILADELPHIA, PA and OXFORD, UK - Researchers at the University of Pennsylvania School of Medicine and Adaptimmune Limited today announced the approval of an Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) and opening for enrollment of the first-ever study using patients’ cells carrying an engineered T cell receptor to treat HIV (SL9  HA-GAG-TCR). The trial may have important implications in the development of new treatments for HIV potentially slowing – or even preventing – the onset of AIDS.

The trial makes use of the body’s natural ability to recognize infected cells by enhancing the power of the T cell receptor (TCR) on killer T cells. When a virus infects cells, it hijacks the host cell machinery in order to replicate and spread infection. These infected cells then expose or “present” small parts of the virus proteins on their surface, offering a "molecular fingerprint" called an epitope for killer T-cells from the immune system to identify. This triggers an immune response, eliminating the virus and any cells involved in its production.  However, HIV not only replicates itself quickly on infection but also has the ability to mutate rapidly, swiftly disguising its fingerprints to allow it to hide from killer T-cells.
 
Researchers at the Oxford University spin-out Adaptimmune have spent a decade working on ways to improve the natural ability of the TCR to recognize infected and cancerous cells; a process which has involved remaking the natural TCR protein and then modifying its ability to bind to the molecular fingerprints of the affected cells. 
 
Last year, with colleagues at the University of Pennsylvania, they engineered and tested a killer T-cell receptor that can recognize all the different disguises HIV is known to have used to evade detection. The researchers transferred this receptor to the killer T-cells to create genetically engineered "bionic assassins" able to destroy HIV-infected cells in culture. Now, less than a year later, they are taking their unique technology into the clinic.

The immune system uses T cell receptors to find and trigger the elimination of infected cells”, says Dr Bent Jakobsen, Chief Scientific Officer at Adaptimmune Ltd. “HIV, however, poses an intractable challenge because it has a phenomenal ability to escape detection through mutation while the immune system is not able to adapt its T cell receptors. Together with our colleagues at the University of Pennsylvania, we have previously shown that it is possible to engineer a T cell receptor that detects the known spectrum of HIV escape mutants for this particular fingerprint and triggers a more potent immune response when transferred into a patient’s cells. Today sees that important research result move into the clinic – for the first time allowing us to test the power of super potent immune cells against HIV in reality.”
 
The trial will be led by Carl June, MD of the Abramson Family Cancer Research Institute and the Department of Pathology and Laboratory Medicine with Pablo Tebas, MD, Director of the adult AIDS Clinical Trials Unit (ACTU), Department of Infectious Diseases Division at the University of Pennsylvania. 
 
“We are treating patients for the first time with an enhanced version of a natural T cell receptor designed to recognize and clear HIV. This is the first time an engineered T cell receptor will be given to patients with HIV infection,” said June. “We will be treating patients currently well-controlled on HAART therapies in order to establish whether the engineered killer T cells containing the receptor are safe, and to identify a range of doses of the cells that can be safely administered. It is a truly an important day for T cell immunotherapy.”

“Using monoclonal antibodies revolutionized the treatment of many rheumatologic and lympho proliferative diseases,” added Tebas, principal investigator on the new trial. “These engineered T cells are the equivalent of monoclonal antibodies in the other big branch of the immune system: the cellular branch. We hope to target cells infected with the HIV virus and eliminate them. This first study will evaluate safety and the right dose of these cells needed to be effective.”
 
According to UNAIDS/WHO figures, over 2.7 million people were infected with HIV in 2007 with over 33 million people estimated to be living with HIV worldwide. No cure or effective vaccine yet exists. Current treatment regimens are based on combinations of different classed of anti-retroviral drugs which although successful in delaying the onset of AIDS for several years, have serious side effects and must be taken daily for life. Drug resistance is also increasingly a problem. New, effective ways to control the disease therefore remain a priority.
 
If the trial confirms the safety and preliminary effectiveness of the engineered T cell treatment for HIV, Adaptimmune plans to conduct a follow-on Phase II trial to confirm efficacy in a larger group of patients.
 

Note: The Penn investigators in this study have no financial interest or other relationship with Adaptimmune LTD, apart from their scientific collaboration in developing the engineered killer T cell, conducting laboratory experiments, and planning human clinical trials.
 

The SL9 HA-GAG-TCR Trial:
The study is an open label, exploratory Phase I multiple arm study to evaluate the safety, tolerability and antiviral effects of escalating doses of a single administration of autologous T cells modified using lentiviral vectors expressing high affinity gag-specific TCRs in patients who are positive for the tissue type HLA A02. The specific target of the TCR is the HIV-1 gag epitope SL9 (SLYNVATL) detectable in 75% of HIV-infected patients with this tissue type.

The process to make the autologous cells at the University of Penn will involve isolating and converting a portion of the patient’s T cells to a single population of killer (CD8+) T cells containing the engineered TCRs. Two TCRs will be compared: the natural wild type TCR for the SL9 epitope (WT-GAG-TCR) and a higher affinity version (HA-GAG-TCR). The trial will enroll a total of twenty-four patients who are currently well-controlled on anti-retroviral medications (HAART) in four equal cohorts. In the first cohort, patients will be infused with WT-GAG-TCR T cells and then start an analytical structured treatment interruption (STI) to their HAART for a maximum of 16 weeks unless criteria for reinstatement of HAART are invoked. After initial dosing, patients will enroll in the second cohort evaluating HA-GAG-TCR T cells. Once a safe dose is established in these two cohorts, the third and fourth cohorts will enroll in which eligible patients will begin an STI and then receive T cell infusions 6 weeks in to their STI of initially WT-GAG-TCR (cohort 3) and then HA-GAG-TCR (cohort 4), unless criteria for HAART reinstatement are invoked. All patients will be followed for 9 months following study treatment.  The primary objective of the study is to evaluate the safety and feasibility of treating patients with HA-GAG-TCR modified T cells.
 

Preclinical data
Preclinical data on SL9 HA-GAG-TCR were published in the journal Nature Medicine (Varela-Rohena, A. et al. Control of HIV-1 immune escape by CD8 T-cells expressing enhanced T-cell receptor. Nature Medicine, 2008 Dec; 14(12):1390-5.) and presented at the European AIDS Conference in Vilnius in April 2009.  Phage display was used to isolate and enhance a T-cell antigen receptor (TCR) originating from a CTL line derived from an infected person and specific for the immunodominant HLA-A(*)02-restricted, HIVgag-specific peptide SLYNTVATL (SL9). High-affinity (KD < 400 pM) TCRs were produced that bound with a half-life in excess of 2.5 h, retained specificity, targeted HIV-infected cells and recognized all common escape variants of this epitope. CD8 T cells transduced with this supraphysiologic TCR produced a greater range of soluble factors and more interleukin-2 than those transduced with natural SL9-specific TCR, and they effectively controlled wild-type and mutant strains of HIV at effector-to-target ratios that could be achieved by T-cell therapy.

About HIV/AIDS
Since the discovery of the human immunodeficiency virus (HIV) in 1984 and its role in the cause acquired immunodeficiency syndrome (AIDS) the HIV pandemic has become one of the most serious challenges to human health in the 21st Century.  UNAIDS estimates indicate that over 33 million people are now living with HIV rising by approximately 1 million per year.  Whilst combinations of highly active anti-retroviral therapy (HAART) have been relatively successful in crippling the virus and delaying by years the onset of AIDS, crucially such therapy does not represent a cure and the combined problems of drug resistance mutations, toxicity and patient adherence raise questions about the long-term efficacy of treatment as well as the cost and availability of such drugs in poorer parts of the world where the pandemic is most acute.  More recently, hopes that vaccines could be used to control the disease by provoking an immune response to the virus have also begun to fade as it has become apparent that HIV’s phenomenal capacity for variation enables it to out-run, and eventually over-run, the human immune system . New approaches are needed that reach beyond these existing efforts, barrier methods and behavioral changes which can truly prevent or cure HIV infection.
 
About the University of Pennsylvania (PENN)
PENN Medicine is a $3.6 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.

Penn's School of Medicine is currently ranked #3 in the nation in U.S.News & World Report's survey of top research-oriented medical schools; and, according to the National Institutes of Health, received over $366 million in NIH grants (excluding contracts) in the 2008 fiscal year. Supporting 1,700 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.
 
The University of Pennsylvania Health System (UPHS) includes its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nation's top ten "Honor Roll" hospitals by U.S.News & World Report; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center, named one of the nation's "100 Top Hospitals" for cardiovascular care by Thomson Reuters. In addition UPHS includes a primary-care provider network; a faculty practice plan; home care, hospice, and nursing home; three multispecialty satellite facilities; as well as the Penn Medicine at Rittenhouse campus, which offers comprehensive inpatient rehabilitation facilities and outpatient services in multiple specialties.
 








 
« Last Edit: January 13, 2014, 11:52:42 AM by Jeff G »

Offline brazilianman

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Re: bionic assassins- T-cell killer
« Reply #12 on: October 07, 2009, 05:02:55 PM »

 ???
someone will join this trial?
 ???

Offline Inchlingblue

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Re: bionic assassins- T-cell killer
« Reply #13 on: October 07, 2009, 07:43:13 PM »
Thanks for posting this, it sounds promising.

Offline Inchlingblue

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Re: bionic assassins- T-cell killer
« Reply #14 on: October 22, 2009, 06:30:20 PM »
reply e-mail  adaptimmune

Dear bman
 
Thank you for getting in touch and your interest in the Adaptimmune technology.  Because the technology relies on a person’s own T cells (i.e. human cells) it is very difficult to test usefully in animals in early testing due to rejection of the cells.  It is possible, however, to do some testing in certain sorts of mice  and this is what we have been able to do along with many laboratory tests on human cells to provide the necessary data for the regulatory authorities to be happy to proceed for clinical testing in patients.  We are hoping to start our first clinical trial in HIV patients in the US very soon (before the end of 2009) and yes we are hopeful that the activated T cells should be able to find HIV-infected cells even when the virus is controlled and present at very low levels.
 
I hope this is useful and would like to thank you again for your interest in the technology.
 
Yours sincerely
 


Helen Tayton-Martin PhD MBA
Chief Operating Officer



 ;D

Does her reply mean that they are hoping/expecting that these bionic Tcells will reach the reservoirs?

Offline freewillie99

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Re: bionic assassins- T-cell killer
« Reply #15 on: October 26, 2009, 11:18:47 AM »
Does her reply mean that they are hoping/expecting that these bionic Tcells will reach the reservoirs?


Sure sounds like that to me.
Beware Romanians bearing strange gifts

Offline emeraldize

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Re: bionic assassins- T-cell killer
« Reply #16 on: October 26, 2009, 11:28:26 AM »
Hello,

Placed a call and am awaiting a call back as Larisa is with a patient. I will inquire about whether or not they will now, or will eventually include LTNPs in the study and I'll ask Inchling's question about the expectations regarding reservoirs.

Em

called again today--still awaitying reply
« Last Edit: October 27, 2009, 05:05:38 PM by emeraldize »

Offline brazilianman

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Re: bionic assassins- T-cell killer
« Reply #17 on: November 14, 2009, 03:35:15 PM »

 ???

SOMEONE WILL TAKE PART OF THIS TRIAL?

 ???


Offline emeraldize

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Re: bionic assassins- T-cell killer
« Reply #18 on: November 14, 2009, 05:08:50 PM »
Glad you posted Brazilianman...

I did receive a call back (not long after I posted) and they are not enrolling LTNPs in the study population. To answer Inchling's question, yes, they fully expect to reach reservoirs using the activated T cells .

I hope someone enrolls, too.

Offline Inchlingblue

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Re: bionic assassins- T-cell killer
« Reply #19 on: November 14, 2009, 06:59:16 PM »
Glad you posted Brazilianman...

I did receive a call back (not long after I posted) and they are not enrolling LTNPs in the study population. To answer Inchling's question, yes, they fully expect to reach reservoirs using the activated T cells .

I hope someone enrolls, too.

Thanks so much for that. Sounds very intriguing.

Offline brazilianman

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Re: bionic assassins- T-cell killer
« Reply #20 on: December 16, 2009, 07:56:07 AM »

This study is being done here at the University of Pennsylvania in Philadelphia. We are looking for folks who are HIV positive, CD4 > 450, undetectable viral load and a stable med regimen. There are over 19 visits in a 9 month period, so you would have to reside in or close to Philadelphia. Although participants are compensated for being in the trial, there is no compensation for travel or overnight stays, if that is required for you. I have attached a consent form for the study. It is for your information only. You do not need to sign it. It contains valuable information about the study and its requirements. Thank you for your interest in clinical trials at Penn.
 
Yours truly,
Larisa





University of Pennsylvania
Office of Regulatory Affairs
Yvonne Higgins, Director Human Research Protections
Emma Meagher, MD, IRB Executive Chair
3624 Market St., Suite 301 S
Philadelphia, PA 19104-6006
Ph: 215-573-2540/ Fax: 215-573-9438
INSTITUTIONAL REVIEW BOARD
(Federalwide Assurance # 00004028)
16-Nov-2009
Pablo Tebas
502 Johnson Pavilion
Philadelphia, Pa 19104-6073
Attn: Ro Kappes
Email: rkappes@mail.med.upenn.edu
PRINCIPAL INVESTIGATOR : PABLO TEBAS
TITLE : A pilot, open label, multiple arm, single center study to evaluate the
safety and tolerability of escalating doses of autologous T cells
modified with lentiviral vectors expressing high affinity gag-specific
TCRS in HLA-A*02 patients with HIV
SPONSORING AGENCY : ADAPTIMMUNE
PROTOCOL # : 810108
REVIEW BOARD : IRB #3
Dear Dr. Tebas:
IRB approval has been given to the above referenced protocol as of 12-Nov-2009. This study will be due
for continuing review on or before 14-Jan-2010.
Approval by the IRB does not necessarily constitute authorization to initiate the conduct of a human
subject research study.
Principal investigators are responsible for assuring final approval from other applicable school, department,
center or institute review committee(s) or boards has been obtained. This includes, but is not limited to, the
University of Pennsylvania Cancer Center Clinical Trials Scientific Review and Monitoring Committee
(CTSRMC), Clinical and Translational Research Center (CTRC) review committee, CAMRIS committee,
Institutional Bio-safety Committee (IBC), Environmental Health and Radiation Safety Committee (EHRS),
and Standing Conflict of Interest (COI) Committee. Principal investigators are also responsible for assuring
final approval has been obtained from the FDA as applicable, and a valid contract has been signed between
the sponsor and the Trustees of the University of Pennsylvania. If any of these committees require changes
to the IRB-approved protocol and informed consent/assent document(s), the changes must be submitted to
and approved by the IRB prior to beginning the research study.
If this protocol involves cancer research with human subjects, biospecimens, or data, you may not begin the
research until you have obtained approval or proof of exemption from the Cancer Center's Clinical Trials
Review and Monitoring Committee.
The revisions, in response to a full board review, were reviewed and approved by Dr. Emma Meagher,
Executive Chair of the IRB (or her authorized designee), using the expedited procedure set forth in 45 CFR
46.110(b).
The following documents were included in this review:
Documents included in this submission:
. HS-ERA Response Submission, submitted on 11/4/2009
. Cover Letter, dated 10/6/2009
. IBC Letter, dated 7/28/2009
Letter from the FDA re: the IND number, dated 10/27/2009
. Email Regarding No Clinical Hold, dated 9/4/2009
. Pre-IND Package Request, dated 3/13/2009
. Revised Informed Consent Form for Arms 1-2, dated 9/30/2009
. Revised Informed Consent Form for Arms 3-4, dated 9/30/2009
. Revised Protocol, Version 1.0, dated 9/29/2009
. Data and Safety Monitoring Plan, Version 1.0, dated October 2009
. Table of Changes, submitted on 11/4/2009
. Grant Application, submitted on 10/6/2009
. Study Procedures Table, Version 1.0, submitted on 11/4/2009
. Statistical Plan, Version 1.0, submitted on 10/6/2009
. Modified IND application, submitted on 10/14/2009
. Gwendolyn Binder CITI completion report, completed on 6/8/2009
. Michael Kalos CITI completion report, completed on 1/28/2009
. Email correspondence with Dr. Boyer re: CITI completion, dated 6/23/2009
. Email correspondence with the FDA, dated 9/30/2009
Documents included with the original submission:
. Email Correspondence from NIH RAC Committee, dated 5/13/2008
. Dr. Carl June's COI Disclosure form, submitted on 6/22/2009
. Responses to Appendix M, dated 4/22/2008
When enrolling subjects at a site covered by the University of Pennsylvania's IRB, a copy of the IRB
approved informed consent form with the IRB approved from/to stamp must be used unless a waiver of
written documentation of consent has been granted.
The IRB has received a HIPAA Authorization Form which will be used for all study subjects, which is
presumed to be accurate. Disclosure of any protected health information outside the constraints of the
authorization is prohibited. It is mandatory that you obtain a new authorization or submit a waiver request
to change the current terms of the disclosure authorization in any way.
If you have any questions about the information in this letter, please contact the Regulatory Affairs
administrative staff. Contact information is available at our website:
http://www.upenn.edu/regulatoryaffairs/Contact.html.
Thank you for your cooperation.
Sincerely,
IRB Administrator
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 1 of 20
UNIVERSITY OF PENNSYLVANIA
RESEARCH SUBJECT
INFORMED CONSENT FORM + HIPAA AUTHORIZATION
Protocol Title: A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE
SAFETY AND TOLERABILITY OF ESCALATING DOSES OF AUTOLOGOUS T CELLS MODIFIED
WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Principal
Investigator:
Pablo Tebas, M.D.
Department of Medicine, Division of Infectious Diseases (ID)
3400 Spruce Street
Philadelphia, PA 19104
Telephone: (215) 349‐8091
Emergency Contact
(24/7):
Infectious Disease Resident on‐call
Telephone: (215) 662‐6059
Why am I being asked to volunteer?
The doctors at the Hospital of the University of Pennsylvania, with funding support from a
company named Adaptimmune Limited and the National Institutes of Health, are studying HIV
infection and possible new ways of treating HIV. This is called clinical research.
You are being asked to participate in this research study because you are HIV positive and are
taking medication to control your virus, you have a CD4 count greater than or equal to 450 ,
you know your lowest recorded CD4 count (this is called a CD4 nadir), and you have the
recorded value of your viral load when you were not taking anti‐HIV drugs (this is called a viral
load set point).
You are being invited to participate in a research study. Your participation is voluntary which
means you can choose whether or not you want to participate. If you choose not to participate,
there will be no loss of benefits to which you are otherwise entitled. Before you can make your
decision, you will need to know what the study is about, the possible risks and benefits of being
in this study, and what you will have to do in this study. The research team is going to talk to
you about the research study, and they will give you this consent form to read. You may also
decide to discuss it with your family, friends, or family doctor. You may find some of the
medical language difficult to understand. Please ask the study doctor and/or the research team
about this form. If you decide to participate, you will be asked to sign this form.
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 2 of 20
What is the purpose of this research study?
This research study is being carried out to study a new way to possibly treat HIV. T‐cells are one
of the white blood cells used by the body to fight HIV. CD8 T‐cells are a type of T‐cell used by
the body to detect and kill cells which have been infected by foreign viruses or organisms,
including the HIV virus. CD8 T‐cells must identify the HIV virus in order to kill it. Because HIV is
constantly changing the way it looks to the CD8 T‐cells, some of the HIV virus escapes detection
and is not killed by the CD8 T‐cells.
This research study uses a protein called SL9 TCRs and adds it to the CD8 T‐cells in the
laboratory in order to help the CD8 T‐cells recognize the constantly changing HIV virus and
make it able to fight HIV more efficiently. TCR stands for T cell receptor and is found on the
surface of T cells (type of white blood cell).
Laboratory studies have shown that when CD8 T‐cells are modified with SL9 TCRs, they kill cells
that are infected with HIV better than normal CD8 T‐cells can. On the basis of these laboratory
results, there is the potential that SL9 TCRs may work in people infected with HIV and improve
their immune system by killing HIV infected cells and thus partially preventing the virus from
spreading.
Two different SL9 TCRs will be tested in this study, WT‐gag‐TCR and α/6‐gag‐TCR. Two
different types of SL9 TCRs are being used in this research study because the laboratory studies
suggest that the different SL9 TCRs will function differently depending on the amount of virus in
your body. A goal of this clinical study is to test each SL9 TCRs in the presence or absence of a
viral load. Patients enrolled into Groups (Arms) 1 and 2 (this is your group) will be given T cells
expressing SL9 TCRs while your virus is still undetectable.
In order to incorporate the SL9 TCR into the CD8 T‐cells, the laboratory will have to put the SL9
TCR into a delivery vehicle called a viral vector. Viral Vectors are used to deliver genetic
material into a cell. In this research study, this viral vector is called a lentiviral vector. The
vector is added to your cells (which will be collected from your blood) at the beginning of the
manufacture process and the SL9 TCR is then able to enter the CD8 T‐cells. This process is
known as gene transfer or gene therapy. It is hoped that by adding the SL9TCR to the CD8 Tcells
they will be able to “see” the virus.
The purpose of this research study is to find out whether the “SL9 TCR CD8+ T‐cells” are:
1) safe to give to humans
2) find how the “SL9 TCR CD8+ T‐cells” affects HIV
3) find out how long the “SL9 TCR CD8+ T‐cells” stay in your body
This is a safety and feasibility study. We will closely monitor you and study whether giving you
“SL9 TCR CD8+ T cells” will cause any side effects. In addition, the study will test how long the
“SL9 TCR CD8+ T cells” will last in your body and if it has any‐HIV effects.
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 3 of 20
The “SL9 TCR CD8+ T cells” is experimental and has not been approved by the United States
Food and Drug Administration. Cells modified with “SL9 TCR CD8+ T cells” have never been
given to humans. There is the possibility that “SL9 TCR CD8+ T‐cells” may not work or that they
may have negative side effects.
You will receive a single dose of SL9 TCR expressing CD8 T cells. This dose will be split across
three daily infusions of increasing numbers of cells (10%, 30% and 60% of the total dose in each
infusion). This will allow the investigators to evaluate the safety of the infusions over a period
of time. Between each infusion you will be evaluated to determine whether it is safe to
proceed with the next infusion.
An overview of the study is provided in a picture format below. ART is antiretroviral therapy,
and STI indicates an interruption of your ART:
How long will I be in the study? How many other people will be in the study?
A total of 12‐24 subjects are expected to participate in this portion of the study conducted at
the University of Pennsylvania. Active participation in this research study is expected to last
approximately one year.
Rectal
Biopsy
Rectal
Rectal Biopsy
Biopsy
Screening
Study Drug Prep
-10 weeks 0 9wk 17wk
Rectal
Biopsy
Successful ART
Leukapheresis
ART
Monthly
until virus
below detection
Safety labs
STI
16 week STI Successful ART
1 wk 9mo
Infusions*
* Infusions split across day 0, 1, and 2 at 10%, 30%, and 60% of total dose, respectively
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 4 of 20
At the end of this study, you will be asked to enroll into a follow‐up study for an additional 15
years since this study uses lentiviral vectors to deliver the study drug (this is called gene
transfer) to your cells. At this time, a study team will go over the follow‐up protocol with you in
detail and you will also undergo the informed consent process (as you are for this study) for you
to participate in the follow‐up protocol. The purpose of this follow‐up study is to monitor you
for any side effects of the gene transfer. It can take years to detect a side effect from gene
transfer. Under the follow‐up protocol, you will be asked to come in twice a year for blood
tests for 5 years. If the study agent is no longer detected in your blood at five years, a study
coordinator will contact you by phone or by survey each year for the next 10 years. If the study
agent is still detected in your blood at 5 years, you will be asked to return annually for blood
draws until it is no longer detected.
Definition of Terms Used Above:
1) Vital Signs – temperature, blood pressure, heart rate, respiratory rate and possibly a pulse
ox (blood oxygen levels). Normally done during a Physical Exam.
2) Physical examination – temperature, blood pressure, heart rate, respiratory rate, pulse ox
(blood oxygen levels). (these are also called vital signs), current medications and a doctor or
nurse will examine you and ask you how you are feeling.
3) Detailed medical history – the doctor or study nurse will ask you about all previous medical
conditions, past and current medications you may be taking, and participation in any prior
clinical trials.
4) Blood draw (approximately 2‐4 tablespoons) – blood will be taken from a vein in order to
monitor your health and for research.
5) Pregnancy Test – at Screening, two weeks prior to your first infusion, and a urine pregnancy
test will be required just prior to each infusion.
6) Urine Sample – will be requested in order to monitor your health
7) Examination of your veins – a nurse or doctor will look at the veins in your arms to make
sure you have good enough veins to undergo a procedure (called apheresis) that will be
used to isolate your T‐cells for modification by ““SL9 TCR CD8+ T cells”.
8) The apheresis procedure is the removal of your white blood cells (in this case we will collect
T‐cells from your apheresis product) from your blood. In order to collect your T‐cells you
will have one needle inserted in each arm. The machine will take blood from the vein in one
arm through tubing and passes through a machine called an apheresis machine which will
separate your T‐cells from the rest of your blood and then return the blood not collected
through the tubing and back to you in your other arm. This is a sterile procedure and uses a
solution called Acid‐citrate‐dextrose (ACD) and a salt solution (called saline) during the
process to prevent your blood from clotting within the tubing of the machine. A small
Approved from 11/12/2009 Approved to 01/14/2010

Offline brazilianman

  • Member
  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #21 on: December 16, 2009, 07:59:30 AM »
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 5 of 20
amount of this solution will also be returned to you along with your red blood cells and
platelets during the process. This procedure usually lasts around two to three hours. The
apheresis procedure is necessary in order to collect your white blood cells and then remove
and modify (change) your CD8 T‐cells with “lentiviral vector” may help the CD8 T cells to
identify and kill the HIV virus more efficiently. This modification takes approximately 3‐4
weeks to complete. The “SL9 TCR CD8+ T cells” become the study drug, which you will
receive by intravenous infusion. Group (Arm) 1 will receive WT‐gag‐TCR and Group (Arm 2) will
receive α/6‐gag‐TCR modified T cells.
9) Rectal Biopsy ‐ Rectal biopsies will be performed between your initial screening visit and 2
weeks prior to the first dose of SL9 TCR CD8+ T cells, and then at 1, 9, and 17 weeks after
your first infusion. Based on your medical history, your doctor may determine that you
need to take antibiotics for a few days before the procedure, if you have another condition
that requires antibiotics at the time of the biopsy.
During this procedure several small samples are taken of the skin lining the inside your
rectum; the lining regrows within a day or so. The biopsy procedure takes approximately 30
minutes to complete and is performed in the outpatient clinic. The biopsy does not usually
require pain medications. The procedure will be done by trained gastroenterologists
(intestinal specialists). This will help us measure the effect of SL9 TCR modified T cells on the
HIV virus and figure out where all the cells with the SL9 TCR are going in your body. You may
still continue on the study and receive the SL9 TCR modified T cells even if you decline to
undergo the repeat rectal biopsies now, later, or for the entire study.
You must refrain from anal sex or insertion of any object in the rectum for 3 weeks after
each rectal biopsy procedure.
10) Pulse Ox – measurement of oxygen status by a small machine attached to your finger
11) Treatment Interruption– The purpose of a planned treatment interruption is to let the
antiviral drugs wash out of your body, so that the effects of the immune system and the SL9
TCR CD8+ T cells on HIV can be measured. There are several approaches to begin the
treatment interruption. Your doctor will discuss the options with you given your particular
antiviral medications, and you will choose which approach to use for stopping the antiviral
medications. The non nucleoside reverse transcriptase inhibitor (NNRTI) class of
medications like Rescriptor, Sustiva and Viramune are known to stay in your body longer
than non‐NNRTIs (NRTIs). One approach is to discontinue the NNRTI immediately, then in
48 hours stop the other antiretroviral drugs. The second approach is to stop taking the
NNRTI, continue taking the NRTIs and start taking a potent protease inhibitor‐based
regimen, for two weeks, and then stopping all antiretroviral drugs. You will remain on
treatment interruption for 16 weeks. The period of treatment interruption may be
shortened if medically necessary (for example if your viral load increases to above 100,000
or your CD4 count drops below 350).
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 6 of 20
What am I being asked to do?
Prior to taking part in this study, you and your doctor should discuss the current standard
treatments for HIV, including all alternative medical options. The study doctor or his staff will
ask you to read and sign this Informed Consent Form after all of your questions have been
answered.
Once you decide to participate, you will have to undergo a screening process to determine if
you are eligible to participate in this study. In order to determine if you are eligible to
participate in this study, you will be required to undergo the following (please note underlined
words are defined after the table below)
Once you have completed the screening visit and it is determined by your doctor that you can
enter the study, you will follow the schedule below for visits and evaluations. You will receive a
single dose of the study drug over a series of three infusion visits, performed on consecutive
days as outlined in the table below. You will receive either a low or high total dose of the study
drug, depending on when you enroll in the study. This is called a “dose escalation” and is
designed to increase the safety of the study by testing the safety of the dose first at low levels.
You will only receive either the low or high dose, and the study nurse or principal investigator
can tell you which dose you will receive.
Day What you do
Apheresis #1
(~2 weeks after
Screening)
 collection of white blood cells
 vital signs
 takes about 60‐90 minutes
Apheresis #2
(~4 weeks after
Apheresis #1)
 collection of white blood cells
 vital signs
 takes about 60‐90 minutes
Day What you do
Screening  Physical Exam
 Blood draw (2 tablespoons; may include pregnancy test)
 Detailed medical history
 Examination of your veins in your arms will be checked by
Apheresis Unit
 Urinalysis
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 7 of 20
Day What you do
Rectal Biopsy
(anytime after
screening to just
prior to Day 0)
 GI clinic for rectal biopsy (optional)
Clinic Visit
~2 weeks prior Day 0
 physical exam
 blood draw (2.2 tablespoon; may include pregnancy test)
Day 0
First Infusion of
WT‐gag‐TCR and
α/6‐SL9‐TCR
 Please note you will be kept in the clinic for at least two hours after
your infusion.
 physical exam
 blood draw (3.4 tablespoon and possibly urine pregnancy test)
 Urinalysis
 Vital signs will be taken before and after infusion, and every 15
minutes for at least one hour.
 medication given prior to infusion: acetaminophen (Tylenol) 650
mg (pills) and diphenhydramine (Benadryl) (pills or IV)
 Infusion of 10% of total dose:
o Subjects in Group (Arm 1) will receive infusion of WT‐gag‐
TCR over approximately 15 minutes IV
o Subjects in Group (Arm 2) will receive infusion of α/6‐SL9‐
TCR over approximately 15 minutes IV

24 hrs after Day 0
Day 2 ‐ Second
Infusion of
WT‐gag‐TCR and
α/6‐SL9‐TCR
 Please note you will be kept in the clinic for at least two hours after
your infusion.
 physical exam
 blood draw (1.7 tablespoon and possibly urine pregnancy test)
 Urinalysis
 Vital signs will be taken before and after infusion, and every 15
minutes for at least one hour.
 medication given prior to infusion: acetaminophen (Tylenol) 650
mg (pills) and diphenhydramine (Benadryl) (pills or IV)
 Infusion of 30% of total dose:
o Subjects in Group (Arm 1) will receive infusion of WT‐gag‐
TCR over approximately 15 minutes IV
o Subjects in Group (Arm 2) will receive infusion of α/6‐SL9‐
TCR over approximately 15 minutes IV
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
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Version 1.0 09‐30‐09 ARMS 1 and 2 Page 8 of 20
Day What you do
48 hrs after
after Day 0
Day 3 ‐ Third
Infusion of
WT‐gag‐TCR and
α/6‐SL9‐TCR
 Please note you will be kept in the clinic for at least two hours after
your infusion.
 physical exam
 blood draw (1.7 tablespoon and possibly urine pregnancy test)
 Urinalysis
 Vital signs will be taken before and after infusion, and every 15
minutes for at least one hour.
 medication given prior to infusion: acetaminophen (Tylenol) 650
mg (pills) and diphenhydramine (Benadryl) (pills or IV)
 Infusion of 60% of total dose:
o Subjects in Group (Arm 1) will receive infusion of WT‐gag‐
TCR over approximately 15 minutes IV
o Subjects in Group (Arm 2) will receive infusion of α/6‐SL9‐
TCR over approximately 15 minutes IV
Clinic Visit
72 hrs after
after Day 0
 physical exam
 blood draw (3.5 tablespoon)
 Urinalysis
Clinic Visit
1 week after
after Day 0
Start of treatment
interruption
 physical exam
 blood draw (3.4 tablespoon)
 GI clinic for rectal biopsy (optional)
 Urinalysis
Clinic Visit
3 weeks after
after Day 0
 physical exam
 blood draw (3.4 tablespoon)
 Urinalysis
Clinic Visit
5 weeks after
after Day 0
 physical exam
 blood draw (1.7 tablespoons)
 Urinalysis
Clinic Visit
7 weeks after
after Day 0
 physical exam
 blood draw (3.5 tablespoons)
 Urinalysis
Clinic Visit
9 weeks after
after Day 0
 physical exam
 blood draw (3.4 tablespoon)
 GI clinic for rectal biopsy (optional)
 Urinalysis
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
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02 PATIENTS WITH HIV
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Version 1.0 09‐30‐09 ARMS 1 and 2 Page 9 of 20
Day What you do
Clinic Visit
11 weeks after
after Day 0
 physical exam
 blood draw (1.6 tablespoons)
 Urinalysis
Clinic Visit
13 weeks after
after Day 0
 physical exam
 blood draw (3.4 tablespoons)
 Urinalysis
Clinic Visit
15 weeks after
after Day 0
 physical exam
 blood draw (3.5 tablespoons)
 Urinalysis
Clinic Visit
17 weeks after
after Day 0
 physical exam
 blood draw (1.7 tablespoons)
 GI clinic for rectal biopsy (optional)
 Urinalysis
 Restart your HIV medication
Clinic Visit
5 months after
after Day 0
 physical exam
 blood draw (3.4 tablespoons)
 Urinalysis
Clinic Visit
6 months after
after Day 0
 physical exam
 blood draw (3.4 tablespoons)
 Urinalysis
Clinic Visit
7 months after
after Day 0
 This visit may not be required if your virus is undetectable at 6
months
 physical exam
 blood draw (3.4 tablespoons)
 Urinalysis
Clinic Visit
8 months after
after Day 0
 This visit may not be required if your virus is undetectable at 6 or 7
months
 exam
 blood draw (3.4 tablespoons)
 Urinalysis
Clinic Visit
9 months after
after Day 0
 physical exam
 blood draw (3.3 tablespoons)
 Urinalysis
 enroll in Long Term Follow Up Study to monitor your health as
required by the Food and Drug Administration (FDA)
After the 9‐month visit, you will be asked to enroll into the long term follow up protocol. In this
protocol, you will be asked to come back twice a year for at least 5 years for blood tests (6
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
tablespoons of blood will be taken from your arm). On your annual visits, a physical
examination, and a medical history will also be taken by the study doctors. These blood tests
are done to look for side effects and to see if your immune system has responded to the SL9
TCR CD8+ T cells. It is important that you complete all follow‐up appointments. If after 5 years,
the infused cells can still be detected in your blood, you will be asked to continue coming back
for the same tests for up to 10 more years. Once the infused cells are no longer detected, you
will not need to return for tests, but will be contacted annually up to 15 years after your first
infusion by mail, phone, and email or through your physician to complete a short survey
regarding your health.
In order for the study doctors to learn more about your HIV status and the effects on the “SL9
TCR CD8+ T cells”, we request that you agree to have an autopsy performed upon your death
no matter when this occurs and what the cause. If you agree to have us contact your family to
request an autopsy at the time of your death, whenever that should occur, please sign on the
final signature page of this form. Please also inform your family that this request is important
and may have benefit to future clinical investigation (research doctors) studying HIV infection.
You can change your mind by notifying your study doctor in writing at any time and withdraw
your permission
.
What are the possible risks or discomforts?
The following side effects may be observed with “SL9 TCR CD8+ T cells”:
 Chills and fever
 Smell of creamed corn or garlic after infusion
 Headache
 Increase in blood pressure
 Low heart rate
 Allergic reaction (itching, swelling of the tongue)
 Seizures
 Nausea and vomiting
 Injection site reactions such as bruising, swelling, black and blue marks, fainting and/or
infection at the site
 Worsening of your HIV infection (increase in HIV‐1 viral load or decrease in T cell count)
 You may be less likely to respond to similar gene therapy trials in the future because you
may develop an immune response to the vector (kind of like an allergy).
 Swelling, low blood pressure, and dermatologic reactions (dry skin, redness, itching, and
sloughing).
 You may be excluded from future gene therapy or vaccine trials as a result of your
participation in this study.
 There may be unknown risks that may lead to death.
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 10 of 20

Offline brazilianman

  • Member
  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #22 on: December 16, 2009, 08:04:37 AM »
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 11 of 20
Although the effects of the “SL9 TCR CD8+ T cells” on unborn children are not known, this is a
high risk clinical study and therefore there could be serious harm to unborn children or
children who are breast‐feeding. These effects could also harm the mother. It is also possible
that harmful side effects that are not yet known could happen to both the mother and unborn
or breast‐feeding child.
If you are currently pregnant, it is important that you inform the investigator because you will
not be able participate in the study. If you are able to become pregnant, you will be given a
pregnancy test before entry into the study. You are asked to use a medically accepted
method of birth control such as condoms, diaphragm or cervical cap with spermicide,
intrauterine device, and hormonal contraception (condoms are recommended because they
are the only birth control method that functions as a barrier for HIV infection while you
participate in the study). You are strongly urged to use at least two forms of birth control
during the course of this study.
You should not become pregnant while you are taking this drug. If you do become pregnant,
you must tell the investigator and consult an obstetrician or maternal‐fetal specialist.
Additional risks:
Risks associated with apheresis:
After the apheresis procedure you may experience temporary discomfort, including irritation,
swelling or bruising at the place where the needle was inserted into your vein to collect the
blood. Apheresis can also occasionally cause: nausea, vomiting, fainting, seizures, blood loss,
infection, skin rash, flushing, hives, numbness and tingling (especially in your mouth and lips),
or swelling of your feet and ankles.
Risks associated with HAART treatment interruption:
Possible side effects from stopping antiretroviral therapy include the development of drug
resistant HIV, an increased risk for HIV transmission during this period, lower CD4 T cell counts,
higher viral loads which could cause a worsening of your HIV infection and potentially death.
There is also the risk of other clinical events not related to HIV. In some subjects on other trials,
the virus does not return in the blood after stopping antiviral therapy; it is not known if this will
happen in this study.
It is possible that you could develop an allergy to your HIV medication. In rare instances,
subjects have become allergic to abacavir (Ziagen™) when they stop taking the medication and
then later begin taking abacavir. For this reason, it is necessary that you take your medication in
the presence of others, and not while alone, when you first restart your HIV medication.
Risks associated with antibody formation:
Your white blood cells isolated by the apheresis procedure will have further processing that will
isolate and expand the CD8 T cells needed for your treatment. The separation is accomplished
by using a system in which mouse antibodies are used. Residual mouse antibodies, which are
proteins that are foreign to your body, can elicit an antibody response in your body.
Approved from 11/12/2009 Approved to 01/14/2010
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
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Version 1.0 09‐30‐09 ARMS 1 and 2 Page 12 of 20
Furthermore, it is also possible that you may develop antibodies to other residual proteins (e.g.
VSV‐G proteins that are present on “SL9 TCR CD8+ T cells”) that may not have been completely
removed during the manufacturing process. The result of this is that your body could develop
antibodies to the "foreign" proteins which could lead to an allergic reaction, such as skin rash,
itching and fever. More serious allergic reactions that require medical treatment could also
occur, such as shortness of breath and drop in your blood pressure. Depending on the nature
of your symptoms, you may or may not receive further infusions. However, rigorous tests are
in place to make sure that foreign residual proteins are completely removed but it is possible
that some residual protein could remain.
Risks associated with blood draws:
Occasionally there are risks associated with blood draws such as bruising, swelling, black and
blue marks, fainting and/or infection at the site. You may also experience a decrease in
hemoglobin and hematocrit (red blood cell number, called anemia) from having blood drawn
frequently.
Risks associated with rectal biopsies:
Rectal biopsies may cause mild rectal discomfort, a feeling like you need to defecate (bowel
movement), and a small amount of rectal bleeding for 2‐3 days after the biopsy. Rectal abscess
(an infection with pus) or making a hole in the rectal wall (perforation) are very rare
complications that could need antibiotic treatment or surgical repair. Study volunteers will be
followed in clinic as well as the surgical clinic for any complications.
Potential risk of autoimmune disease:
The use of SL9 TCR modified T cells could potentially result in an illness which doctors call
“autoimmune disease”. Our bodies have an immune system that protects us from disease and
infection. When you have an autoimmune disease, your immune system attacks itself by
mistake and you can get sick. Autoimmune diseases can affect the tissues which binds together
body tissues and organs. Autoimmune disease can affect many parts of your body, like your
nerves, muscles, the endocrine system (system that directs your body’s hormones and other
chemicals), and digestive system. Autoimmune disease may be life threatening.
Potential risk of blood cancer:
The study involves giving a person some cells that have been changed by a retroviral vector. A
retroviral vector is a virus that can insert genetic material into cells. When retroviral vectors
enter a normal cell in the body, the deoxyribonucleic acid (DNA) of the vector inserts itself into
the normal DNA in that cell. This process is called DNA integration. Most DNA integration is
expected to cause no harm to the cell or to the patient. However, there is a chance that DNA
integration might result in abnormal activity of other genes. In most cases this effect will have
no health consequences.
However, there is a chance that there may be some regions of the normal human DNA where
insertion of SL9 TCR DNA may result in activation of neighboring genes. For example, if the SL9
TCR DNA attaches to a place that tells your body to start growing a cell, this may cause
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02 PATIENTS WITH HIV
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Version 1.0 09‐30‐09 ARMS 1 and 2 Page 13 of 20
uncontrollable growth of the cell, resulting in cancer. This type of event has occurred in animal
studies in mice and monkeys. We do not know if the retroviral vector used in this protocol
might cause a new malignancy. However, you should be aware that the DNA contained in
retroviral vectors will integrate into your DNA and that under some circumstances, this has
been known to cause malignant (cancerous) growth months to years later.
It is important that you know about some cancers that occurred in another gene therapy
research study. The study, conducted in France, involved a disease called X‐linked Severe
Combined Immunodeficiency (SCID). Years after receiving cells that were modified by a
retroviral vector, a significant number of the children in this small study (4) developed a
leukemia‐like malignant disease (cancer). In addition, one child from a similar study in England
also developed cancer. At least one child died from the cancer. A group of experts in this field
studied the results from tests performed on these children’s blood cells. They concluded that
the leukemia‐like malignancy was caused by the retroviral vector DNA. However, several of the
children with X‐linked SCID who have received experimental gene therapy have not been found
to have a leukemia‐like disease at this time. Although they appear healthy, we still do not know
whether they, too, will develop a malignant growth.
Risks associated with a Replication Competent Lentivirus or “RCL”:
SL9 TCR (the gene product being used in this study) is made from parts of HIV. To make sure you
are as safe as possible, SL9 TCR has not been made from the parts of the HIV virus that can cause it
(SL9 TCR) to grow in your body (like HIV). However, there is a risk that SL9 TCR could mutate
(change) and grow once it has been given to your T cells. This would be called a replication
competent lentivirus, or “RCL”.
The risks of an RCL are unknown, but it is possible that it could make you sicker than you are now.
It is theoretically possible that RCL could make your HIV infection progress more rapidly. To date,
no patient has developed an RCL.
To minimize the possibility of you developing an RCL, the experimental treatment you will be
receiving (SL9 TCR‐modified T cells) will be tested for an RCL just prior to being given to you. You
will also be monitored for an RCL during each of your scheduled follow‐up visits. If one of the tests
used to detect an RCL is positive during these visits, for your safety, you will be notified and
requested to return for blood tests each week for up to 2 weeks to confirm the result. A positive
blood test does not mean that you have an RCL. However, if your blood tests remain positive, you
will undergo apheresis and another test will be performed on your removed white blood cells (CD4
T cells). This test will clearly determine whether or not you have developed an RCL. The result of
this test will not be available for 2‐6 weeks. During this time, you will be closely monitored in the
clinic. Should the test result show that you have an RCL, there is no approved treatment for an
RCL, but medical and research experts will work with you to design the best care available based
upon your health.
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02 PATIENTS WITH HIV
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Version 1.0 09‐30‐09 ARMS 1 and 2 Page 14 of 20
Risks associated with cytokine release syndrome:
The infused cells may react to HIV once in your body, and cause a reaction which results from a
large number of your white blood cells being turned on at the same time. This could cause
something called a cytokine release syndrome. This is inflammation that occurs throughout the
body. This can result in fever and make you feel very ill like you have the flu. In extreme cases
cytokine release syndrome can be life threatening, but this is unlikely with close monitoring. The
reason for the split dose over three infusions is to avoid this potential risk. In extreme cases,
cytokine release syndrome may lead to death.
What if new information becomes available about the study?
During the course of this study, we may find more information that could be important to you.
This includes information that, once learned, might cause you to change your mind about being
in the study. We will notify you as soon as possible if such information becomes available.
What are the possible benefits of the study?
You will not get any benefit from being in this research study. There is a foreseeable future
benefit to other HIV patients who may benefit from a therapy developed based on the
knowledge learned from this study.
What other choices do I have if I do not participate?
The alternative is to not participate in the research and to consider other anti‐HIV treatment
that your doctor has suggested. You do not have to participate in this study to receive
treatment for your HIV illness. If you decide not to participate in this study you will continue to
be treated by your primary physician.
Will I be paid for being in this study?
You will receive a total of $700.00 for completing this study to reimburse you partially for your
time and effort. Please note that if you receive more than $600.00 in compensation in one year
for participation in research studies at the University of Pennsylvania, you must report this as
income to the federal government for tax purposes. The payment schedule is as follows:
1. After 1st Apheresis: $100
2. After 2nd Apheresis: $50
3. First rectal biopsy: $50
4. After first infusion: $75
5. After second infusion: $75
6. After third infusion: $75
7. Second rectal biopsy $50
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A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
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8. Third rectal biopsy $50
9. Fourth rectal biopsy $50
10. After 6 month visit: $50
11. After 9 month visit: $75
Total compensation for the trial: $700
Will I have to pay for anything?
You and/or your health insurance may be billed for the costs of medical care during this study if
these expenses would have happened even if you were not in the study, or if your insurance
agrees in advance to pay.
The “SL9 TCR CD8+ T cells” will be supplied at no cost to you.
What happens if I am injured or hurt during the study?
If you have a medical emergency during the study you should go to the nearest emergency
room. You may contact the Principal Investigator or Emergency contact listed on page one of
this form. You may also contact your own doctor, or seek treatment outside of the University of
Pennsylvania. Be sure to tell the doctor or his/her staff that you are in a research study being
conducted at the University of Pennsylvania. Ask them to call the telephone numbers on the
first page of this consent form for further instructions or information about your care.
In the event of any physical injury resulting from research procedures, medical treatment will
be provided without cost to you, but financial compensation is not otherwise offered from the
University of Pennsylvania. If you have an illness or injury during this research trial that is not
directly related to your participation in this study, you and/or your insurance will be responsible
for the cost of the medical care of that illness or injury.
When is the Study over? Can I leave the Study before it ends?
This study is expected to end after all participants have completed all visits, and all information
has been collected. This study may also be stopped at any time without your consent because:
 The Primary Investigator feels it is necessary for your health or safety. Such an action
would not require your consent, but you will be informed if such a decision is made and
the reason for this decision.
 You have not followed study instructions.
 The Sponsor, the study Principal Investigator, Office of Human Research Protection
(OHRP), National Institutes of Health (NIH), or the Food and Drug Administration (FDA)
has decided to stop the study.
If you decide not to continue participating, you are free to leave the study at anytime.
Withdrawal will not interfere with your future care. Upon leaving, you will be asked to undergo
a final physical exam, and you will also be asked to enroll into the long term follow up protocol
to aid in long term safety evaluation of the study drug you received. If your participation in the
Approved from 11/12/2009 Approved to 01/14/2010

Offline brazilianman

  • Member
  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #23 on: December 16, 2009, 08:13:53 AM »
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 16 of 20
study has been discontinued due to a concern over your health or safety, you will be followed
clinically on a schedule to be developed with the principal investigator of this protocol and/or
your primary care or HIV physician.
Who can see or use my information? How will my personal information be protected?
The investigator and staff involved with the study will keep your personal health information
collected for the study strictly confidential.
What information about me may be collected, used or shared with others?
The following personal health information will be collected, used for research, and may be
disclosed during your involvement with this research study:
 Name, address, telephone number, date of
birth
 Personal and family medical history,
allergies; prior hospital
admission/discharge information
 Current and past medications or therapies
 Social security number
• Information from a physical examination
that generally also includes blood pressure
reading, heart rate, breathing rate and
temperature
• Results of tests and procedures you will
undergo during this research study as
described in this informed consent form
Why is my information being used?
Your information is used by the research team to contact you during the study. Your
information and results of tests and procedures are used to:
 do the research
 oversee the research
 to see if the research was done right.
Who may use and share information about me?
The following individuals may use or share your information for this research study:
 The Principal Investigator and the Investigator’s study team
 Authorized members of the workforce of the UPHS and the School of Medicine, and
University of Pennsylvania support offices, who may need to access your information in
the performance of their duties (for example: for research oversight and monitoring, to
provide treatment, to manage accounting or billing matters, etc.).
Who, outside of the School of Medicine, might receive my information?
 The funding sponsors (Adaptimmune Ltd.) and the National Institutes of Health (NIH).
Regulatory and safety oversight organizations
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DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
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Version 1.0 09‐30‐09 ARMS 1 and 2 Page 17 of 20
 The Food and Drug Administration
 The Office of Human Research Protections
 The Office of Biotechnology Activities and their committees overseeing gene therapy
research
 The study Data and Safety Monitoring Board
Once your personal health information is disclosed to others outside the School of Medicine, it
may no longer be covered by federal privacy protection regulations.
The Principal Investigator or study staff will inform you if there are any additions to the list
above during your active participation in the trial. Any additions will be subject to University of
Pennsylvania procedures developed to protect your privacy.
How long may the School of Medicine use or disclose my personal health information?
Your authorization for use of your personal health information for this specific study does not
expire.
Your information may be held in a research database. However, the School of Medicine may
not re‐use or re‐disclose information collected in this study for a purpose other than this study
unless:
 You have given written authorization
 The University of Pennsylvania’s Institutional Review Board grants permission
 As permitted by law
Can I change my mind about giving permission for use of my information?
Yes. You may withdraw or take away your permission to use and disclose your health
information at any time. You do this by sending written notice to the investigator for the study.
If you withdraw your permission, you will not be able to stay in this study.
What if I decide not to give permission to use and give out my health information?
Then you will not be able to be in this research study.
Who can I call with questions, complaints or if I’m concerned about my rights as a research
subject?
If you have questions, concerns or complaints regarding your participation in this research
study or if you have any questions about your rights as a research subject, you should speak
with the Principal Investigator listed on page one of this form. If a member of the research
team cannot be reached, or you want to talk to someone other than those working on the
study, you may contact the Office of Regulatory Affairs with any concerns or complaints at the
University of Pennsylvania by calling (215) 898‐2614.
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DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
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Version 1.0 09‐30‐09 ARMS 1 and 2 Page 18 of 20
Do any of the doctors or scientists involved with this study have a conflict of interest that
may bias their decision making?
Adaptimmune is a biotechnology company located in Oxford England, who is developing high affinity
TCRs for use in this research study. In addition, some of the laboratory investigators on this
protocol have invented procedures that are used in the production of the “zinc finger” modified
T‐cells. Therefore, Adaptimmune, as well as some of the laboratory investigators on this
protocol may benefit financially from the results of this clinical research study.
The doctors at the University of Pennsylvania who would enroll you into this study and who
would manage your care do not have any financial benefits from conducting this study.
The regulatory sponsor of this study, who is the person who reports to the Food and Drug
Administration, National Institutes of Health and to the University about the status and results
of the study has a potential financial interest since he invented the technology that expands
your cells. Therefore, he may receive royalties if the technology is ultimately made
commercially available.
When you sign this form, you are agreeing to take part in this research study. This means
that you have read the consent form, your questions have been answered, and you have
decided to volunteer. Your signature also means that you are permitting the University of
Pennsylvania Health System and the School of Medicine to use your personal health
information collected about you for research purposes within our institution. You are also
allowing the University of Pennsylvania Health System and the School of Medicine to disclose
that personal health information to outside organizations or people involved with the
operations of this study.
A copy of this consent form will be given to you.
Name of Subject (Print) Signature of Subject Date
Name of Person Obtaining Consent
(Print)
Signature of Person Obtaining Consent Date
Check box if you agree to an autopsy in the event of your death, whenever that should
occur.
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Offline brazilianman

  • Member
  • Posts: 92
Re: bionic assassins- T-cell killer
« Reply #24 on: December 16, 2009, 08:15:15 AM »
A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
DOSES OF AUTOLOGOUS T CELLS MODIFIED WITH LENTIVIRAL VECTORS EXPRESSING HIGH AFFINITY GAG‐SPECIFIC TCRS IN HLAA*
02 PATIENTS WITH HIV
Informed Consent Form and HIPAA Authorization
Version 1.0 09‐30‐09 ARMS 1 and 2 Page 19 of 20
Check box if you agree to have us contacts your family to request an autopsy in the event of
your death, whenever that should occur, please sign below. You can change your mind at any
time and withdraw this permission.
Name of Subject (Print) Signature of Subject Date
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A PILOT, OPEN LABEL, MULTIPLE ARM, SINGLE CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF ESCALATING
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02 PATIENTS WITH HIV
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ADDENDUM TO INFORMED CONSENT FORM
Future Use of Blood and Tissue for Research: In addition to the study and the analysis of blood and
tissue outlined above, researchers are also interested in potentially using blood that may be
obtained from you during the study for other investigations. These research tests may be
developed during the time you are on study or, in some cases, years later. We ask that you give
approval for these tests to be performed using these specimens. Because it is not possible for you
or the researchers conducting this study to know what will be discovered in the future and what
additional tests may be appropriate at that time, we ask that you give your permission for such
studies without being contacted for permission for each test. These tests may provide additional
information that will be helpful in understanding your disease or response to treatment, but it is
unlikely that what we learn from these studies will have a direct benefit for you. These studies
may benefit patients in the future.
In addition, blood obtained from you may be used to establish products that could be patented or
licensed. There are no plans to provide financial compensation to you should this occur. These
tests will not involve the study of cancer genes that can be inherited. If studies of genes that might
cause cancer are proposed, and you give permission to be contacted, we would contact you and
ask for your permission to conduct such tests at that time.
You have the right to withdraw your sample from further use by contacting or Dr. Pablo Tebas at
215‐349‐8091.
Samples will be stored indefinitely. Researchers involved in this study at the Abramson Family Cancer
Research Institute of the University of Pennsylvania will have access to the specimens. These
specimens may be used to conduct pilot (new) studies regarding your disease or regarding your
response to the kind of treatment you received. Samples may be sent to other researchers for
collaborative studies, including researchers at for‐profit agencies. However, prior to shipment, all
patient identifiers (i.e. initials, medical record numbers) will be removed.
Patients will not be given results of these pilot studies, nor will genetic testing linked to the
patient be performed. Study data from banked blood will not be placed in the patient’s medical
record.
You agree that your blood may be kept for use in research to learn about, prevent, treat, or cure
HIV or other diseases.
______Yes _____No _______Date
Name of Subject (Print) Signature of Subject Date
Name of Person Obtaining Consent
(Print)
Signature of Person Obtaining Consent Date
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Offline Inchlingblue

  • Member
  • Posts: 3,119
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Re: bionic assassins- T-cell killer
« Reply #25 on: December 16, 2009, 11:23:08 AM »
Brazilianman: Do you have links to this research or is this something they emailed you?

Thanks ;)

I guess the link below is for the clinical trial. This is similar to the recent stem cell research on CD8s.

LINK:

http://clinicaltrials.gov/ct2/show/NCT00991224?term=tcrs&rank=1
« Last Edit: December 16, 2009, 12:28:36 PM by Inchlingblue »

 


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