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

NCT03114566 | Terminated

• 1 other identifier: 17-211
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

transplant donor; HLA typed; 17-211

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Consenting healthy donor

Transplant and healthy HLA typed donors

Other: Leukapheresis

Interventions

Leukapheresis OTHER

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.

Consenting healthy donor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transplant donors and healthy HLA typed volunteers

You may qualify if:

• 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

You may not qualify if:

• HTLV/HIV (+) or Hepatitis B or C positive donors
• Donors who are pregnant

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Leukapheresis

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Susan Prockop, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: April 5, 2017
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

US (1)