This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25. Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10\^6/kg,1.5×10\^6/kg, 5.0×10\^6/kg CAR+ cells.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose limiting toxicity (DLT)
DLT within 28 days (±3 days) after CAR-T-19 infusion.
Time frame: up to 2 years
Maximum tolerated dose (MTD)
The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Time frame: up to 2 years
Adverse events
Percentage of subjects with adverse events.
Time frame: up to 2 years
Overall recovery rate (ORR)
Percentage of subjects who achieved complete response (CR) and incomplete hematologic recovery (CRi) for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Time frame: up to 2 years
MRD-Negative Rate
Percentage of subjects with MRD-negative CR and incomplete blood and MRD-negative CRi for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Time frame: up to 2 years
Duration of Response (DOR)
The time from achieving CR and CRi for the first time to recurrence or death from any cause
Time frame: up to 2 years
Progression-free Survival (PFS)
The time from CAR-T-19 infusion to recurrence, progression or death from any cause, whichever occurs first.
Time frame: up to 2 years
Overall survival (OS)
The time from CAR-T-19 infusion to death from any cause.
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Time frame: up to 2 years