Study of CT0596 CAR-T Cell Therapy for Adults with Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and cellular metabolic behavior of CT0596 CAR-T cell injection in patients with relapsed or refractory multiple myeloma and plasma cell leukemia. This early phase 1 clinical trial aims to understand how this investigational treatment affects these conditions, which are forms of blood cancer that have returned or not responded to prior therapies. The study is sponsored by The First Affiliated Hospital of Soochow University and focuses on patients who have had multiple prior treatments. Participants receive an infusion of CT0596 chimeric antigen receptor T CAR-T cells, a type of immune cell therapy designed to target cancer cells. This treatment is administered during the study period, and participants are closely monitored for adverse effects and how their disease responds. The study includes long-term follow-up to assess safety and treatment impact over time, with careful tracking of the dose range and biological activity of the CAR-T cells. Throughout the trial, participants undergo regular assessments including monitoring for side effects, measuring disease response, and evaluating survival outcomes over 12 months after infusion. Researchers collect blood samples to study cytokine levels and CAR copy numbers, and track overall and progression-free survival rates. Participants agree to follow-up visits and evaluations for up to 15 years to support comprehensive safety and efficacy monitoring.

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