Recruiting

Adoptive Cell Therapy

Sponsor:

National Cancer Institute (NCI)

Code:

NCT02821806

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Healthy Volunteer

Study ID

NCT02821806

Start date

Aug 8, 2016

Status verified date

Jun 9, 2026

Completion date

Feb 1, 2035

Anticipated

Primary completion date

Mar 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • Age greater than or equal to 18 years old and able to give consent.
  • Adequate clinical parameters (all of the following):

  • Afebrile (temperature less than or equal to 37.5 degree C)
  • Systolic blood pressure less than or equal to180 mmHg
  • Diastolic blood pressure less than or equal to100 mmHg
  • Weight greater than or equal to 110 lbs.
  • Heart rate between 50-100 beats/minute
  • Adequate bilateral antecubital venous access for a 2 arm apheresis procedure
  • Females of child-bearing potential should not be pregnant or breast-feeding.
  • Within 30 days of pheresis donation, donors must be negative for infectious disease work-up: Antibody screen for Hepatitis B, Hepatitis C; HIV, HTLV-I/II, T. cruzi (Chagas agent), West Nile, and syphilis (RPR)
  • Within 30 days of pheresis donation, donor must have:

  • Hemoglobin:

  • Women greater than or equal to 12.5 gm/dL
  • Men greater than or equal to 13.0 gm/dL
  • Platelets greater than or equal to 100,000/microliter
  • Total WBC greater than or equal to 2 K/microliter

EXCLUSION CRITERIA:

  • History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.
  • Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.
  • Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.
  • Active malignancy will exclude the donor. Any history of malignancy will be considered on a case by case basis in accordance with NIH/DTM criteria.
  • If the participant answers Yes to any initial screening question, the participant will be considered ineligible.
  • If the participant is deferred according to DTM Cellular Therapy Screening Standard Operating Procedures (SOP), the participant will be considered ineligible.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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 ]
  • Improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapy [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Laura A Parsons-Wandell, R.N.

(240) 858-7480laura.parsons-wandell@nih.gov

Scott M Norberg, D.O.

(301) 275-9668scott.norberg@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 17, 2026

Last verified

Jun 9, 2026

Keywords

  • Normal Volunteer
  • Donation
  • Adoptive T Cell Therapies
  • Peripheral Blood Mononuclear Cells
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-17.