This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)
Age 3 to 18. Weight ≥10kg
Relapsed or refractory acute lymphoblastic leukemia (ALL).
Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.
Active Central Nervous System (CNS) involvement by malignancy.
Isolated extra-medullary disease relapse.
Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
History of concomitant genetic syndrome
Single group
single dose of CNCT19
Biological/VaccineAutologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously. Lymphodepletion treatment: Drugs:Fludarabine Drugs: Cyclophosphamide
Overall Remission Rate (ORR)
ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification, as determined by Independent Review Committee (IRC)
Overall complete Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators
MRD negativity status as determined using flow cytometry
Overall Remission Rate (ORR) as determined by IRC and Investigators
The Investigators' evaluation results of ORR will be utilized in the sensitivity analysis
Overall Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators
MRD negativity as determined using flow cytometry
Best overall response (BOR)
The proportion of patients who have achieved the best response (CR or CRi) after CNCT19 treatment
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