Study of CNCT19 Treatment for Children and Adolescents Ages 3 to 18 with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CNCT19 treatment in children and adolescents aged 3 to 18 years with relapsed or refractory B-cell acute lymphoblastic leukemia rr B-cell ALL. This multi-center, open-label, single-arm phase IbII trial aims to find the optimal dose and study how the treatment works in this pediatric population. The study includes both initial safety and dosing evaluation and a later phase focused on efficacy and safety. Participants will receive a conditioning chemotherapy regimen with fludarabine and cyclophosphamide before a single intravenous infusion of CNCT19, which consists of autologous 2nd generation CD19-directed CAR-T cells. The study periods include screening, pre-treatment for cell product manufacture and lymphodepletion, infusion of CNCT19, followed by safety and efficacy follow-up, and long-term survival monitoring lasting up to two years after infusion. During the trial, participants will undergo various assessments including monitoring of remission rates within three months, evaluation of minimal residual disease, response duration, survival rates, adverse events, pharmacokinetics, cytokine levels, and immunogenicity. Researchers will also track allogeneic stem cell transplant rates and laboratory abnormalities. Follow-up visits and sample collections will continue for up to two years to comprehensively assess treatment effects and participant safety.

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