CAR T Cells for Mesothelioma

Recruiting in Palo Alto (17 mi)

Overseen by Raffit Hassan, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with solid tumors, including mesothelioma, that have not responded to standard treatments. Participants must have enough of a protein called MSLN in their tumors and will undergo procedures like leukapheresis and biopsies.

Inclusion Criteria

Ability of participant to understand and the willingness to sign a written informed consent document.

Participant must have at least 1 measurable lesion by RECIST version 1.1.

I am 18 years old or older.

Exclusion Criteria

Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency).

History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.

I do not have any ongoing illnesses that could affect my safety or participation in the study.

Participant Groups

The study tests TNhYP218 CAR T cells, which are the participant's own immune cells modified to attack tumor cells with high levels of MSLN. It includes pre-treatment drugs, infusion of the CAR T cells, and extensive follow-up visits for up to 15 years.

Group I: 2/Dose Expansion Experimental Treatment 4 Interventions

Participants with mesothelioma will undergo lymphodepletion and will receive TNhYP218 CAR T cells at the RP2D determined in Arm 1

Group II: 1/Dose Escalation Experimental Treatment 4 Interventions

Participants with mesothelin expressing tumors will undergo lymphodepletion and will receive TNhYP218 CAR T cells at escalating doses

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References