NCT03114566TerminatedNot Applicable
Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors
Memorial Sloan Kettering Cancer Center1 site in 1 country1 target enrollmentStarted: April 5, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Generation of T-cells
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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)
- •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
Outcomes
Primary Outcomes
Generation of T-cells
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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