Phase I Study of CLL1 and CD38 Dual-Target CAR-T Cell Injection for Safety and Preliminary Effectiveness in Adults with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are investigating the safety and early effectiveness of a special treatment called CLL1 and CD38 dual-target CAR T cell injection for adults with relapsed or refractory acute myeloid leukemia AML. This phase I, open-label, dose-escalation study focuses on patients whose leukemia has returned or not responded to previous treatments. The trial aims to understand how well this dual-target CAR-T therapy works and its possible risks. The study involves a single treatment arm where participants receive the CAR T cell injection modified to target both CLL1 and CD38 proteins found on leukemia cells. The trial includes two phases the first uses an accelerated titration design to find a safe dose, and the second follows a 33 design to further evaluate dosing. Participants may undergo allogeneic hematopoietic stem cell transplantation after receiving the CAR-T cells if needed. During the study, participants will be closely monitored for dose-limiting toxicities within the first 28 days and tracked for adverse events over 96 weeks. Researchers will assess various outcomes including remission rates, survival, and cell behavior in the body. Participants will undergo regular tests and evaluations according to the study protocol, with follow-up visits scheduled for up to nearly two years after treatment to measure long-term safety and response.

A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia