CD19 CAR T cell therapy BY19 for pediatric and adult patients with relapsed or refractory B cell neoplasms in Belarus: Phase 1 trial.

ABSTRACT: Access to chimeric antigen receptor (CAR) T cell therapy remains limited in many developing countries. We conducted a single-arm, open-label, phase 1 trial (NCT05333302) at two Belarusian centers, evaluating an in-house manufactured CD19 CAR T cell product (BY19) in pediatric and adult patients with relapsed/refractory B cell malignancies. Lymphodepletion included fludarabine/cyclophosphamide, with or without decitabine. Twenty-three patients received therapy: seventeen B cell acute lymphoblastic leukemia, one chronic lymphocytic leukemia, and five non-Hodgkin lymphomas. Cytokine release syndrome (CRS) occurred in 67% of infusions, mostly grade 1-2, with severe CRS in 19%. Immune effector cell-associated neurotoxicity occurred in 44%, with severe cases in 18.5%. The overall response rate w

SUBMITTER: Katsin M 

PROVIDER: S-EPMC12664381 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature