Actively Recruiting

Age: 18Years - 120Years
All Genders
Healthy Volunteers
NCT02821806

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

Led by National Cancer Institute (NCI) · Updated on 2026-04-24

500

Participants Needed

1

Research Sites

964 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 18 years old and able to give consent
  • Afebrile with temperature less than or equal to 37.5 degrees Celsius
  • Systolic blood pressure less than or equal to 180 mmHg
  • Diastolic blood pressure less than or equal to 100 mmHg
  • Weight greater than or equal to 110 lbs
  • Heart rate between 50 and 100 beats per minute
  • Adequate bilateral antecubital venous access for a two-arm apheresis procedure
  • Females of child-bearing potential must not be pregnant or breastfeeding
  • Negative infectious disease tests within 30 days before donation, including Hepatitis B, Hepatitis C, HIV, HTLV-I/II, T. cruzi (Chagas), West Nile virus, and syphilis
  • Hemoglobin at least 12.5 gm/dL for women, 13.0 gm/dL for men within 30 days before donation
  • Platelet count at least 100,000 per microliter within 30 days before donation
  • Total white blood cell count at least 2,000 per microliter within 30 days before donation
Not Eligible

You will not qualify if you...

  • History of medical illness that prevents donation of PBMCs as determined by the principal investigator or physician
  • Current psychiatric diagnosis that compromises donation compliance or informed consent
  • Presence of any blood-transmissible infectious disease that cannot be cleared prior to donation
  • Active malignancy; history of malignancy evaluated case-by-case
  • Positive answers to initial screening questions
  • Deferral according to Cellular Therapy Screening Standard Operating Procedures

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

L

Laura A Parsons-Wandell, R.N.

CONTACT

S

Scott M Norberg, D.O.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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