This is a single-center, open-label, non-randomized, single-arm Phase 1 Study to evaluate safety and tolerability of optimized Dual CD33/CLL1 CAR T Cells in subjects with refractory or relapsed acute myeloid leukemia. Maximum of twenty subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 250 mg/m\^2/day) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10\^6 (±20%) to dose 2: 5×10\^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10\^5 (±20%) /kg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 250 mg/m\^2/day) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10\^6 (±20%) to dose 2: 5×10\^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10\^5 (±20%)
Beijing Boren Hospital
Beijing, Beijing Municipality, China
Dose limiting toxicity (DLT)
DLT assessment according to the clinical study protocol
Time frame: 21 days post intravenous injection
Incidence and severity of adverse events (AE)
Time frame: 30 days post intravenous injection
Objective response rate (ORR)
Objective response rate (ORR) according to NCCN, Complete response (CR),CR with incomplete blood count recovery (CRi)
Time frame: 28 days post infusion
Concentration of PK CAR positive T cells in peripheral blood
Proliferation and survival of CAR T cells in peripheral blood.
Time frame: 30 days post infusion
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