Collecting Healthy Cells for Cancer Immunotherapy Research

This observational study is collecting healthy immune cells, called Peripheral Blood Mononuclear Cells (PBMCs), from volunteers. These cells are crucial for developing new cancer treatments that use a patient's own immune system (adoptive cell therapy). Researchers will use your healthy cells to grow T cells (a type of immune cell) for cancer patients. The goal is to improve how these cells are collected and expanded for future therapies. You can join if you are a healthy adult, aged 18 to 120 years, with normal blood pressure and temperature, and weigh at least 110 lbs. The study is ongoing and aims to enroll 500 participants.

Study design
This is an observational study with a planned enrollment of 500 healthy participants.
What's involved
You will be screened with a standard donor questionnaire about your health and medical history. The study involves collecting lymphocytes through leukapheresis.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT02821806

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

Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~500 participants
Updated 2026-08-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancer
Measured over ongoing
+1 more outcome measured
Healthy Volunteer
1 sites across 1 states
Maryland1
  • Scott M Norberg, D.O. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

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Eligibility criteria

Inclusion

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

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.
  • Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancerongoing

    Collection of PBMC cells.

  • Improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapyongoing

    Scientific advancement.