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Trial record 10 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Unrelated Donors"

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

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ClinicalTrials.gov Identifier: NCT03114566
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Healthy Other: Leukapheresis

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Group/Cohort Intervention/treatment
Consenting healthy donor
Transplant and healthy HLA typed donors
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Transplant donors and healthy HLA typed volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114566


Contacts
Contact: Susan Prockop, MD 212-639-6715 prockops@mskcc.org
Contact: Miguel-Angel Perales, MD 212-639-8682

Locations
United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Susan Prockop, MD    212-639-6715      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Susan Prockop, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03114566     History of Changes
Other Study ID Numbers: 17-211
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
transplant donor
HLA typed
17-211