NCT02821806 Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
| NCT ID | NCT02821806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Healthy Volunteer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-08-08 |
| Primary Completion | 2030-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2016-08-08 with a primary completion date of 2030-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Scott M Norberg, D.O.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT02821806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02821806 currently recruiting?
Yes, NCT02821806 is actively recruiting participants. Contact the research team at laura.parsons-wandell@nih.gov for enrollment information.
Where is the NCT02821806 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02821806 clinical trial?
NCT02821806 is sponsored by National Cancer Institute (NCI). The principal investigator is Scott M Norberg, D.O. at National Cancer Institute (NCI). The trial plans to enroll 500 participants.