This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 250 mg/m\^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) 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: 2×10\^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
Enrollment
19
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 (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 250 mg/m\^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Beijing Boren Hospital
Beijing, Beijing Municipality, China
Incidence and type of dose-limiting toxicity (DLT)
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: 30 days post infusion
Quantification of CAR T cells
Quantification of CAR T cells by flow cytometry and/or quantitative PCR in peripheral blood and cerebral spinal fluid (CSF).
Time frame: 2 years post infusion
Severe adverse events (SAE)
The incidence of any severe adverse event (SAE) and the severity of SAE from day 30 to 2 years.
Time frame: 2 years post infusion
Best overall response (BOR)
Best overall response (BOR) rate at 3 months.
Time frame: 3 months post infusion
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