Phase 12 Study of P134 CAR-T Cell Therapy for Adults with Recurrent Glioblastoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of P134 cells in adults with recurrent or progressive glioblastoma, specifically grade 4 glioblastoma IDH wild-type. This Phase 12 clinical trial aims to find the maximum tolerated dose MTD and recommended Phase 2 dose RP2D of these dual-targeting CAR-T cells, also studying their behavior in the cerebrospinal fluid. The study is led by experts from Beijing Tiantan Hospital and the Chinese Academy of Engineering. The trial uses P134 cells, which target CD44 and CD133 markers on tumor cells. In Phase 1, dosing starts at 1 x 108 CAR-T cells and escalates through two higher dose levels, given every two weeks either directly into the tumor or into the brains ventricles via a reservoir device. Phase 2 will expand dosing at one or two levels chosen based on safety and response data, enrolling up to 10 participants per dose level. Participants will be monitored from the first dose through about two and a half years for dose-limiting toxicities, adverse events, tumor response, progression-free survival, and overall survival. Evaluations include imaging and laboratory tests to measure tumor size and treatment effects. Safety and efficacy data will guide dose recommendations, with study involvement lasting until the end of follow-up periods.

A Clinical Trial of P134 Cells in Recurrent Glioblastoma