Phase 1 Study of MT027 Delivered into the Pleural Cavity for Patients with Pleural Malignant Tumors

What this Trial Is About

Researchers are evaluating MT027, a CRISPRCas9 edited B7H3-specific allogeneic CAR-T cell therapy, in adults with pleural malignant tumors who have previously received standard care. This phase I, open-label, single-arm study aims to assess the feasibility, safety, tolerability, pharmacokinetics, pharmacodynamics, and to determine the recommended dose of MT027 delivered directly into the pleural cavity. Participants must have tumors that overexpress the B7H3 antigen. MT027 is administered by injection into the pleural cavity on day 1 of a 28-day cycle, followed by a 28-day monitoring period for dose-limiting toxicities. If no significant toxicity or disease progression occurs, treatment continues every three weeks with injections on day 1 or 2 of each 21-day cycle. After the first dose, participants stay in the hospital for at least seven days for close monitoring and safety assessments. Dose adjustments or temporary treatment interruptions may be made based on tolerance and adverse events. Participants will receive treatment until intolerable side effects, disease progression, withdrawal, or death. Safety is assessed through adverse event monitoring, including serious events, graft-versus-host disease, cytokine release syndrome, and neurotoxicity over about one year. Follow-up continues for up to 15 years with periodic telephone check-ins. The study includes laboratory tests, clinical evaluations, and tumor antigen testing to monitor treatment effects and participant health throughout the trial.

A Study of MT027 in Patients with Pleural Malignant Tumors