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

Prior treatment

• History of concomitant genetic syndrome
• Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
• Patients who received specified chemotherapy before CNCT19 infusion
• Radiotherapy 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.
• Has had treatment with any prior CAR-T therapy.

Other illness

• Active Central Nervous System (CNS) involvement by malignancy.
• Isolated extra-medullary disease relapse.
• Active systemic autoimmune disease
• Known 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.

Lab values

• Donor lymphocyte infusion (DLI) must be stopped \> 6 week prior to CNCT19 infusion.

Other

• Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
• Life expectancy \< 3 months.

• 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.
• 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 screening
• Organ function requirements: All patients must have adequate renal and liver functions