Open-label Study of U32 CAR-T Cell Therapy to Assess Safety and Effectiveness in Treating Acute Myeloid Leukemia in Patients Aged 2 to 65

What this Trial Is About

Researchers are evaluating U32 injection in patients aged 2 to 65 years with acute myeloid leukemia AML to assess its safety, tolerability, and effective dosage. This single-arm, open-label clinical study focuses on relapsed and refractory AML according to current diagnostic guidelines, including patients who have undergone prior treatments or stem cell transplants. The study is sponsored by Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd and spans phases 1 and 2. Participants will receive U32 CAR-T cell therapy following lymphodepletion preconditioning with cyclophosphamide and fludarabine given over three consecutive days. Patients are enrolled into three dose level cohorts to evaluate different dosing regimens. The study does not include a placebo or control group, and all patients receive the investigational treatment. Throughout the study, researchers will monitor adverse events for 28 days post-infusion to assess safety and tolerability. Additional evaluations over two years include pharmacokinetics and pharmacodynamics of the CAR-T cells, response rates, duration of response, overall survival, and progression-free survival. Participants undergo regular follow-ups with clinical assessments to track treatment effects and safety over time.

Clinical Study of U32 in Patients With Acute Myeloid Leukemia