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NCT03114566 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03114566
Other study ID # 17-211
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 5, 2017
Est. completion date February 2, 2021

Study information
Verified date February 2021
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 information / eligibility
Status Terminated
Enrollment 1
Est. completion date February 2, 2021
Est. primary completion date February 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
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: - HTLV/HIV (+) or Hepatitis B or C positive donors - Donors who are pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Leukapheresis
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.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year
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