Phase I Study Evaluating Safety and Dose of BCMA-targeted CAR T-cell Therapy MDC-CAR-BCMA001 for Adults with Relapsed or Refractory B-cell Cancers

What this Trial Is About

Researchers are evaluating the safety and maximum tolerated dose of MDC-CAR-BCMA001, which are high-affinity autologous BCMA-targeting CAR T-cells, in patients with relapsed and refractory B-cell malignancies. This phase I trial focuses on diseases such as multiple myeloma and diffuse large B-cell lymphoma that have not responded to previous treatments or have relapsed after therapy. The goal is to determine if this genetic therapy can be administered safely and to find the appropriate dose for future studies. The study involves giving participants a single intravenous infusion of MDC-CAR-BCMA001 following conditioning chemotherapy. The treatment will be tested at four increasing dose levels to identify the maximum tolerated dose or recommended dose for phase II trials. This dose escalation approach helps to evaluate safety and tolerability at different levels of the CAR T-cell therapy. Participants will be closely monitored for approximately 24 months to assess safety outcomes, including the incidence and severity of adverse events, serious adverse events, cytokine release syndrome, neurotoxicity, and dose-limiting toxicities. Researchers will conduct regular evaluations during this period to track these effects and determine the optimal dose. The total participation time and follow-up will help ensure thorough safety assessments throughout the trial.

A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell Malignancies