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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Terminated

Conditions: Healthy

Treatments: Other: Leukapheresis

Study type: Observational

Funder types: Other

Identifiers

NCT03114566

17-211

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

1 participants in 1 patient group

Consenting healthy donor

Description:

Transplant and healthy HLA typed donors

Treatment:

Other: Leukapheresis