Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:8/8/2018
Start Date:April 5, 2017
End Date:April 2020
Contact:Susan Prockop, MD
Email:prockops@mskcc.org
Phone:212-639-6715

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Trial Summary
Trial Overview
Inclusion Criteria
The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer
donors in order to create Good Manufacturing Practice grade banks of virus-specific and
tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for
therapeutic use.


Inclusion Criteria:

- Donors must satisfy standards including those set forth by FACT (Foundation for the
Accreditation of Cellular Therapy) and the criteria specified in FDA 21 Code of
Federal Regulations (CFR) 1271. Specifically, screening for risk factors for
communicable disease as well as infectious disease screening by serologic and PCR
testing as outlined below. Including testing for IV, Hepatitis B, Hepatitis C, HTLV I
and II, CMV, EBV, and toxoplasmosis, westnile virus, syphilis, varicella zoster, and
Chagas disease.

- Donors must be typed for HLA-A, B, C, DR and DQ at high resolution.

- Donors accrued at MSKCC must have a hemoglobin value > 10g/dl

- Donors must be capable of undergoing, at least, a single standard 2 blood volume
leukapheresis or a donation of one unit of whole blood

- Donors must weight >/= 25 kg

Exclusion Criteria:

- HTLV/HIV (+) or Hepatitis B or C positive donors

- Donors who are pregnant
We found this trial at
1
site
Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-6715
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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