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

Summary

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).

Eligibility

Key Inclusion Criteria:

1. Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)
2. Age 3 to 18. Weight ≥10kg
3. Relapsed or refractory acute lymphoblastic leukemia (ALL).
4. Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.
5. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
6. Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age \< 16 years) performance status ≥ 50 at screening
7. Organ function requirements: All patients must have adequate renal and liver functions

Key Exclusion Criteria:

1. Active Central Nervous System (CNS) involvement by malignancy.
2. Isolated extra-medullary disease relapse.
3. Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
4. History of concomitant genetic syndrome
5. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
6. Active systemic autoimmune disease
7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).
8. Patients with active infections at screening.
9. Patients who received specified chemotherapy before CNCT19 infusion
10. 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.
11. Donor lymphocyte infusion (DLI) must be stopped \> 6 week prior to CNCT19 infusion.
12. Has had treatment with any prior CAR-T therapy.
13. Life expectancy \< 3 months.

Conditions2

Browse More Trials