Study of CD19CD22BCMA CAR-T Cell Therapy for Adults with Relapsed or Refractory Multiple Myeloma Evaluating Safety, Tolerability, and Dose Limits in Patients Aged 18 to 75

What this Trial Is About

Researchers are evaluating a new type of cell therapy called autologous chimeric antigen receptor T CAR-T cells that target CD19, CD22, and BCMA in patients with relapsed or refractory multiple myeloma. This early-phase, open-label study aims to assess the safety and tolerability of this treatment and to find the highest dose that patients can safely receive. Additional goals include studying how the therapy behaves in the body, how long the CAR-T cells survive, and its effects on the disease. Participants will go through several phases including screening, collection of their immune cells apheresis, a treatment to prepare their body lymphodepletion, followed by a single intravenous infusion of the CAR-T cells. After the infusion, patients will be closely monitored for dose-limiting toxicities during the first 28 days and followed up for longer-term observations. The study uses a dose escalation approach to find the maximum tolerated dose. During the study, participants will have multiple assessments such as blood tests to measure the concentration and activity of CAR-T cells, immune markers, and signs of disease progression. Researchers will also track overall survival and progression-free survival over two years. Safety and response will be evaluated frequently from the day of infusion through follow-up visits. The total participation duration may extend up to the end of the study, which is expected in late 2027.

A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma