Study of MSLN-CAR T Cells with PD1CTLA-4 Nanobodies for Treating Advanced Solid Tumors in Adults

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new type of cell therapy called autologous mesothelin-targeted chimeric antigen receptor MSLN-CAR T cells that secrete PD-1 and CTLA-4 nanobodies in patients with advanced solid tumors. This early phase 1 clinical study focuses on patients whose cancer has not responded to standard anti-cancer treatments. The study aims to understand how well these specially engineered T cells are tolerated and to determine the appropriate dose for future research. Participants will receive a treatment called BZE2209, which is made from their own T cells modified to target mesothelin, a protein found on tumor cells, and to produce PD-1 and CTLA-4 nanobodies that may help enhance the immune response. The treatment is given through a direct intravenous infusion after the T cells are engineered in the lab using a non-viral method. This is a single-arm, open-label study where all participants receive the experimental treatment. The study includes a dose escalation phase to find the maximum tolerated dose. Throughout the trial, participants will be closely monitored for dose-limiting toxicities within 28 days after treatment. Researchers will also assess secondary outcomes such as objective response rate, progression-free survival, and pharmacodynamics over a 12-month period. Evaluations will include tissue staining for mesothelin and PD-L1 expression, organ function tests, performance status assessments, and other safety and efficacy measures. Participants will be followed from the start of treatment through the study duration, which may last up to several months to a year, to observe treatment effects and safety.

Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors