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 (CT125B) cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma. 9-18 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
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 Gaobo Boren Hospital
Beijing, Beijing Municipality, China
Incidence and type of 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)
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0.
Time frame: 30 days post intravenous injection
Objective response rate (ORR)
Objective response rate (ORR) according to NCCN.
Time frame: 30 days post infusion
Counts and persistence of CAR T cells
Blood samples for determination of persistence/counts of infused CAR T cells will be analysed.
Time frame: 30 days post infusion
Incidence and grade of severe adverse events (SAEs)
Incidence and severity of severe adverse events as assessed by NCI-CTCAE 5.0.
Time frame: 2 years post infusion
Best overall response (BOR) rate
Best overall response (BOR) rate according to NCCN.
Time frame: 3 months post infusion
The counts of CART cells after using CAR T suicidal switch drugs .
The counts of CART cells change when CAR T suicidal switch drugs ( ganciclovir ) are used for 3 days and 7 days respectively.
Time frame: 7 days post administration of ganciclovir
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