Phase I Study of Mesothelin-Targeted CAR T-Cell Therapy for Adults with Mesothelin-Positive Esophagogastric Adenocarcinoma and Peritoneal Carcinomatosis

What this Trial Is About

Researchers are evaluating a new treatment called Mesothelin-targeted CAR T-cell therapy for people with mesothelin-positive esophagogastric adenocarcinoma who also have peritoneal carcinomatosis. This phase I trial aims to study the effects and safety of this therapy delivered directly into the abdomen. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on patients with advanced cancer who have limited treatment options. Participants will have their white blood cells T cells collected through a procedure called leukapheresis. These cells will be modified in a lab to target mesothelin, a protein expressed on their tumors, creating the M28z1XXPD1DNR CAR T cells. The modified cells will then be infused back into the participants abdomen. The therapy period will last about 3 to 4 weeks, during which different doses of the CAR T cells may be given to assess safety and dosage limits. Throughout the study, participants will undergo various assessments including imaging to evaluate tumor response, blood tests to monitor cell counts and chemistry, and tests for infectious diseases. Researchers will track treatment-related side effects for up to one year and determine the maximum tolerated dose of the CAR T cells. Participants must meet strict health criteria to ensure safety. The total participation time includes pre-treatment evaluations, treatment infusion, and follow-up monitoring to observe effects and safety outcomes.

A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer