The National Cancer Institute (NCI) is recruiting patients for a Phase 1 clinical trial testing TNhYP218 CAR-T cells, an anti-mesothelin cell therapy, for people with solid tumors including mesothelioma.
The trial, designated NCT06885697, is conducted at a single site in Maryland. It uses a dose-escalation design (Part 1) to identify the recommended Phase 2 dose, followed by a small expansion cohort (Part 2) focused on mesothelioma. The principal investigator is Raffit Hassan, M.D.
About the Study
Background:
Mesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN.
Objective:
To test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma.
Eligibility:
People aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment.
Design:
Participants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN.
Participants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.
Participant s T cells will be modified in a lab to produce TNhYP218 CAR T cells.
Participants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment.
TNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days.
After discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy.
Long-term follow-up will continue another 10 years.
Treatment Approach
This trial uses genetically engineered T cells that target mesothelin on mesothelioma cells.
Key trial details:
- Phase: Phase 1 (with expansion)
- Sponsor: National Cancer Institute (NCI)
- Principal investigator: Raffit Hassan, M.D.
- Status: Recruiting
Why This Trial Matters
CAR-T cell therapy has revolutionized treatment for blood cancers, and researchers are working to adapt this approach for solid tumors like mesothelioma.
This trial is sponsored by the National Cancer Institute, signaling significant federal investment in mesothelioma research.
Study Locations
The trial is recruiting at:
- National Institutes of Health Clinical Center, Maryland
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening