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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-18
SponsorJuventas Cell Therapy Ltd.

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

Treatment groups

47 Participants
are divided into 1 treatment group

Sponsors and collaborators