Actively Recruiting
Early Phase 1 Study of CT0596 CAR-T Cell Therapy for Adults With Plasma Cell Leukemia to Evaluate Safety, Effectiveness, and Cell Behavior
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-01
27
Participants Needed
1
Research Sites
51 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are exploring the use of CT0596 cells, a type of CAR-T cell therapy, in patients with plasma cell leukemia PCL. This early phase 1, single-arm, open-label trial aims to evaluate the safety, effectiveness, and behavior of these cells in the body. The study includes a dose-escalation and dose-finding process to determine the appropriate dose based on safety and pharmacokinetic data. Participants will receive infusions of CT0596 CAR-T cells. The trial may adjust doses up or down or expand the dose range during the study according to patient responses and tolerability. This approach follows the i33 principle to carefully monitor and manage dosing throughout the trial. During the study, participants will be closely monitored for adverse events and treatment effects for up to 12 months after infusion. Researchers will assess response rates, duration of response, progression-free survival, and overall survival, among other outcomes. Long-term follow-up for up to 15 years is also planned to observe safety and treatment persistence. Regular evaluations include blood tests, cytokine monitoring, and cellular measurements to understand the therapys impact.
CONDITIONS
Brief Title
A Study of CT0596 in Plasma Cell Leukemia
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