Phase 1 Study of CD19 CAR-T Cell Therapy for Children and Young Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Lymphoma

What this Trial Is About

This research aims to estimate the safety and effectiveness of CD19 CAR-T cell immunotherapy in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia or lymphoblastic B-cell lymphoma. The study focuses on patients aged 1 to 30 years and is sponsored by the Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. It is a phase 1 interventional trial designed to evaluate this promising immunotherapy approach in this patient population. Participants receive a cycle of lymphodepleting chemotherapy using fludarabine and cyclophosphamide, followed by a single intravenous infusion of locally produced autologous CD19 CAR-T cells. Before the CAR-T cell infusion, patients are given tocilizumab as premedication to help manage immune responses. The treatment process includes close monitoring during and after infusion. Throughout the study, participants undergo regular assessments to monitor treatment-emergent adverse events within one month, and responses are evaluated 28 days after CAR-T cell infusion. Researchers also track overall survival, event-free survival, and leukemia-free survival over one year. Safety monitoring, laboratory tests, and clinical evaluations support participant care during the trial, which aims to provide comprehensive data on this therapys impact and safety over time.

Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma