Healthy
Conditions
Keywords
transplant donor, HLA typed, 17-211
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.
Interventions
OTHERLeukapheresis
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed