A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)

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).

Key Inclusion Criteria:Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)Age 3 to 18. Weight ≥10kgRelapsed or refractory acute lymphoblastic leukemia (ALL).Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age < 16 years) performance status ≥ 50 at screeningOrgan function requirements: All patients must have adequate renal and liver functionsKey Exclusion Criteria: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 CrisisHistory of concomitant genetic syndromePatients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.Active systemic autoimmune diseaseKnown infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).Patients with active infections at screening.Patients who received specified chemotherapy before CNCT19 infusionRadiotherapy before CNCT19 infusion:Non-CNS site of radiation completed < 4 weeks prior to CNCT19 Infusion; CNS directed radiation completed < 8 weeks prior to CNCT19 infusion.Donor lymphocyte infusion (DLI) must be stopped > 6 week prior to CNCT19 infusion.Has had treatment with any prior CAR-T therapy.Life expectancy < 3 months.