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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Drug: IM73 CAR-T Cells Drug: Fludarabine Two days before cell infusion, patient will be treated with fludarabine for 3 days Drug: Cyclophosphamide: Two days before cell infusion, patient will be treated with Cyclophosphamide for 3 days
Peking University People's Hospital (PKUPH)
Beijing, China
Dose limiting toxicity
≥ Grade 4 adverse event related to CAR-T cells infusion
Time frame: 28 days
Objective response rate
Patients who achieve CR(complete response) or CRi 28 days after CAR-T cells infusuion
Time frame: 28 days
Xiaojun Huang, MD
CONTACT
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