Early Study of Enhanced Autologous CAR-T Cell Therapy Targeting CD19 and BCMA for Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating a treatment using Anti-BCMA and CD19 CAR-T cells for patients with relapsed or refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This open-label, single-site study aims to assess the safety and effectiveness of this treatment in up to 18 participants. The trial focuses on these blood cancers, exploring a therapy designed to target specific cancer markers. Before receiving the CAR-T cell infusion, patients will undergo chemotherapy with cyclophosphamide and fludarabine to prepare the body. On day 0, a single intravenous dose of Anti-BCMA and CD19 CAR-T cells will be given, with doses escalating from 1.0 to 5.0 x105 CAR-T cells per kilogram of body weight. This is an early exploratory clinical study without a placebo or comparator group. Participants will be monitored for up to 2 years after treatment. Researchers will track adverse events and study how the CAR-T cells persist, accumulate, and move within the body. They will also assess progression-free survival, overall survival, and objective response rates. Throughout the study, various tests and evaluations will occur to evaluate safety and treatment response.

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma