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

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Consenting healthy donor	Leukapheresis	Transplant and healthy HLA typed donors

Primary Outcome Measures

Name	Time	Method
Generation of T-cells	1 year	Blood and/or white cell donations will be used for the generation of the T-cells to be used for adoptive immunotherapy.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States

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