Collecting blood cells from healthy volunteers to help cancer treatments
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Expansion of T Cells for Adoptive Cell Therapy
This study is collecting blood cells from healthy volunteers to see if they can help improve cancer treatments by boosting the effectiveness of T cells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02821806 on ClinicalTrials.gov |
What this trial studies
This study aims to collect peripheral blood mononuclear cells (PBMCs) from healthy individuals to support the expansion of T cells for adoptive cell therapy in cancer treatment. Participants will undergo a screening process that includes a health questionnaire and blood tests to ensure they meet eligibility criteria. The collected PBMCs will be used to improve methods for isolating and expanding T cells, which are crucial for developing new cancer therapies. The study focuses on utilizing the immune cells of healthy volunteers to enhance the effectiveness of treatments for patients with cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18 and older who can provide informed consent.
Not a fit: Patients with active infections, certain medical conditions, or those who do not meet the health criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective cancer therapies that harness the body's own immune system.
How similar studies have performed: Other studies utilizing similar approaches to expand T cells for cancer therapies have shown promising results, indicating a potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Scott M Norberg, D.O. — National Cancer Institute (NCI)
- Study coordinator: Laura A Parsons-Wandell, R.N.
- Email: laura.parsons-wandell@nih.gov
- Phone: (240) 858-7480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.