A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
A Phase Ib/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
Juventas Cell Therapy Ltd.
47 participants
Feb 7, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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
Exclusion Criteria14
- 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
- Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
- 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.
- 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.
- 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.
Interventions
Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously. Lymphodepletion treatment: Drugs:Fludarabine Drugs: Cyclophosphamide
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05667506