Exploring Safety, Effectiveness, and Behavior of CT0596 CAR-T Cells in Adults with Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and behavior of CT0596 cells, a type of chimeric antigen receptor T cell therapy, in patients with relapsed or refractory multiple myeloma and plasma cell leukemia. This early-phase, open-label trial explores different dose levels to find the best balance between safety and treatment impact in these patients who have undergone previous therapies. Participants will receive an infusion of CT0596 cells, with doses adjusted according to safety and pharmacokinetic data using a stepwise method. The study includes a dose-limiting toxicity DLT assessment period of 28 days after infusion to evaluate immediate side effects. Dose escalation or reduction may occur, and some patients may be replaced if they cannot be evaluated for DLTs. Follow-up continues for safety and treatment effects beyond this period. During the trial, participants will undergo regular evaluations to monitor adverse events, treatment response, and the behavior of the infused cells in their bodies. These assessments include measuring response rates, survival, and cellular persistence up to 12 months post-infusion. Patients are expected to adhere to visit schedules and may be followed for up to 15 years to track long-term outcomes and safety.

a Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia