Study of CD33 CAR-T Cell Therapy for Safety and Effectiveness in Adults with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are studying the safety and effectiveness of CD33 CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia AML. This early phase 1 trial involves a single-arm, open-label, dose-escalation design to evaluate this biological treatment targeting CD33 in patients whose leukemia has returned or not responded to previous treatments. The study aims to better understand how this therapy works in this challenging condition. Participants will receive CD33 CAR T-cells through intravenous infusion. The trial uses a standard 33 dose escalation method with three different dose levels to determine the optimal dose. The trial plans to enroll between 15 and 27 participants, all receiving the experimental CAR-T cell treatment during the study period. During the study, participants will be closely monitored for safety by tracking dose-limiting toxicities up to 28 days after treatment and recording any treatment-emergent adverse events for up to two years. Researchers will also assess treatment responses such as complete remission, duration of remission, overall survival, and leukemia-free survival over periods ranging from 12 weeks to two years. Participants can expect regular evaluations including clinical exams, laboratory tests, and follow-up visits throughout the study and beyond to measure these outcomes and ensure safety.

A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia