Study of Anti-BCMA/FcRL5 CAR-T Cells for Relapsed and Refractory Multiple Myeloma Evaluating Safety and Effects in Patients Open-Label, Single-Arm Clinical Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Anti-BCMA/FcRL5 CAR-T cell therapy in adults with relapsed and refractory multiple myeloma, a type of blood cancer. This open-label, single-arm Phase 2 study aims to better understand how this treatment works and to establish dosing guidelines for future trials. Participants will undergo screening to confirm diagnosis and eligibility before treatment begins. Participants will first undergo leukapheresis, a procedure to collect immune cells from their blood. These cells will then be modified in the lab to create Anti-BCMA/FcRL5 CAR-T cells. Before receiving these modified cells, participants will get lymphodepleting chemotherapy with fludarabine and cyclophosphamide to prepare their body for the infusion. The CAR-T cells will be given at a dose of 1 to 2 million CAR-positive T cells per kilogram of body weight. After infusion, the medical team will monitor for dose-limiting toxicity and determine the maximum tolerated dose and recommended dose for future studies. During the study, participants will be closely observed from the baseline period through 28 days after CAR-T cell infusion for any adverse events. Various assessments including physical exams, lab tests, and imaging will be performed to monitor health status and treatment effects. Safety and tolerability will be key outcomes to ensure participants' well-being throughout the trial. The total participation time includes screening, treatment, and follow-up monitoring.

Safety and Efficacy of Anti-BCMA/FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)