About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- single dose of CNCT19