Phase 1 Study Testing the Safety of Anti-CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory AML Expressing CD19

What this Trial Is About

Relapsed or refractory acute myeloid leukemia AML especially with the t821 translocation is difficult to treat and often leads to poor outcomes. This form of AML abnormally expresses the CD19 antigen on cancer cells and stem cells, providing a potential target for new therapies. Patients with this subtype who relapse after intensive chemotherapy have limited options, prompting research into innovative treatments like anti-CD19 CAR-T cell therapy. The study evaluates the safety of anti-CD19 CAR-T cell therapy in adults with relapsed or refractory AML expressing CD19. Patients will receive conditioning chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of genetically modified CAR-T cells designed to target CD19 on their leukemia cells. The CAR-T cells are produced using a semi-automated bioreactor in an academic setting. This phase I trial focuses on patients for whom no curative alternatives exist. Participants will be closely monitored after infusion, with assessments including bone marrow biopsies and molecular tests to evaluate treatment response and remission. Safety is tracked by observing side effects like cytokine release syndrome and neurological symptoms. The study measures survival without disease progression one month after treatment and follows patients up to a couple of years to assess CAR-T cell persistence, response duration, and overall outcomes.

Study Investigating the Safety of CD19 CAR-T Cells in Relapsed/Refractory AML Expressing CD19