Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

• Status: RECRUITING
• Trial end date: 2044-06-01

Summary

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.

• Phase: PHASE1

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; fludarabine