Donor-derived CAR-T Cells in the Treatment of AML Patients

A Study to Evaluate the Safety and Efficacy of Donor-derived CAR-T Cells in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia

This is a clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China.

This is a single-center, single-arm, open-label study. This study is planned to enroll about 9 subjects with relapsed or refractory acute myelogenous leukemia and 9 matched donors for leukapheresis and CAR-T cells manufacture. Donor-derived CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.

Inclusion Criteria:

• Refractory or relapsed AML patients.
• Have found an appropriate matched donor for CAR-T cells manufacturing.
• Patients must have evaluable evidence of disease.
• Age ≥ 18 years; Expected survival is more than 3 months.
• ECOG score 0-2 points.
• Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up.
• Adequet liver, kidney, heart and lung function.

Exclusion Criteria:

• Confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia.
• Patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases.
• Prior use of any gene therapy product.
• History of epilepsy or other central nervous system diseases.
• Presence of concurrent active malignancy.
• Active hepatitis B or C virus, patients with HIV or syphilis infection.
• Currently participating in or having participated in other drug clinical trials during past 30 days.
• Active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment.
• Other situations not suitable for the study judged by the investigator.