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

Memorial Sloan Kettering Cancer Center1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy

Interventions

LeukapheresisOTHER

Blood is removed together with an anticoagulant from a vein and separated into white cell rich and red cell rich fractions by centrifugation. The white cells are then saved to generate immune cells and the red cells are reinfused back through the donor's vein.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Generation of T-cells

Blood and/or white cell donations will be used for the generation of the T-cells to be used for adoptive immunotherapy.

Time frame: 1 year

Data from ClinicalTrials.gov

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