Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02821806
Status
Recruiting

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Accepted

Study Details

Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy Background: New therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Researchers want to use the healthy cells of volunteers to perform research studies. To do this, they are collecting lymphocytes through leukapheresis. Objectives: To collect healthy cells from volunteers for research studies for new cancer therapies. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a standard donor questionnaire. It asks about their health and past medical problems. It also asks about risky behaviors that could increase their exposure to viruses or bacteria that could be transmitted through a transfusion. Participants will give a blood sample to make sure they are able to donate. They will have a physical exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might give a urine sample. Participants will undergo apheresis. For this, a needle is placed in a vein in each of their arms. Their blood is taken from one arm. A machine separates the white cells from the red cells and plasma by a spinning process. The white cells are removed and directed into a plastic bag. The red cells and plasma are returned through the needle in the other arm. The entire procedure takes 4 6 hours. Participants may donate every 21 days in this protocol if they choose to.

Key Dates

Start date
Aug 8, 2016
Status verified
Jun 2026
Primary completion
Mar 1, 2030
Completion
Feb 1, 2035

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Cohort 1
    Healthy Volunteers

Primary Outcome Measure

Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancer [ Time Frame: ongoing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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