CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19⁺ Relapsed/Refractory Malignancies.

ABSTRACT: We evaluated the administration of ARI-0001 cells (chimeric antigen receptor T cells targeting CD19) in adult and pediatric patients with relapsed/refractory CD19⁺ malignancies. Patients received cyclophosphamide and fludarabine followed by ARI-0001 cells at a dose of 0.4-5 × 10⁶ ARI-0001 cells/kg, initially as a single dose and later split into 3 fractions (10%, 30%, and 60%) with full administration depending on the absence of cytokine release syndrome (CRS). 58 patients were included, of which 47 received therapy: 38 with acute lymphoblastic leukemia (ALL), 8 with non-Hodgkin's lymphoma, and 1 with chronic lymphocytic leukemia. In patients with ALL, grade ≥3 CRS was observed in 13.2% (26.7% before versus 4.3% after the amendment), grade ≥3 neurotoxicity was observe

SUBMITTER: Ortiz-Maldonado V 

PROVIDER: S-EPMC7854276 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature