Study of Anti Tim-3CD123 CAR-T Cell Therapy for Adults Aged 18-70 with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

This research aims to evaluate the safety and effectiveness of anti Tim-3CD123 CAR-T cell therapy for treating patients with relapsed or refractory acute myeloid leukemia AML. The study focuses on improving the targeting of leukemia stem cells LSCs by using both Tim-3 and CD123 markers. Tim-3 has higher specificity for LSCs compared to CD123 alone, potentially reducing harmful effects on normal blood stem cells and decreasing complications such as infections and organ damage. Participants will receive a prespecified dose of their own engineered CAR-T cells that target both Tim-3 and CD123. This therapy is designed to better recognize and attack leukemia cells while sparing normal cells. The study includes early and later phase evaluations to assess dose safety and treatment response over time. During the study, participants will be closely monitored for side effects and treatment outcomes. The primary measure is dose-limiting toxicity within 28 days after the CAR-T cell infusion. Secondary outcomes include response rates, event-free survival, and overall survival assessed at 3, 6, 12, 18, and 24 months. Participants will undergo regular clinical assessments and laboratory tests to track their health and response to the therapy throughout the study period.

Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)