Safety and Dose-Escalation Study of Autologous CD64 CAR T Cell Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are studying a Phase 1, open-label trial to evaluate the safety, expansion, persistence, and early clinical effects of genetically modified autologous T cells called CD64 CAR T cells in adults with refractory or relapsed acute myeloid leukemia AML. The study aims to identify the safety profile and maximum tolerated dose of this experimental treatment using a dose-escalation design. Participants will receive lymphodepleting chemotherapy followed by infusion of the CD64 CAR T cells, which are lentivirally transduced T cells expressing anti-CD64 chimeric antigen receptors with tandem CD3 and 4-1BB costimulatory domains. The study focuses on dose escalation to determine the best tolerated dose and will monitor manufacturing success and dose failures alongside clinical activity. During the trial, participants will be closely monitored for safety and treatment effects from Day 0 through Day 42, with further follow-up up to 12 months post infusion. Researchers will assess overall response rate, survival, progression-free survival, duration of response, and the need for rescue stem cell transplant. Participants will undergo assessments including lab tests, performance status evaluations, and disease evaluations, with long-term follow-up required if the CAR T therapy is administered.

CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AML