Phase 1 study of CD19 CAR T-cell therapy harboring a fully human scFv in CAR-naive adult patients with B-ALL.

ABSTRACT:

Abstract

CD19-directed chimeric antigen receptor-engineered (CAR) T-cell therapy elicits high response rates but fails to induce durable responses in most adults with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). In a previous clinical trial, we observed anti-CAR immune responses associated with impaired in vivo CAR T-cell expansion after second infusions. Because these CD8+ T-cell responses were predominantly directed at peptides derived from the murine single-chain variable fragment (scFv) in the CAR, we conducted a clinical trial investigating the safety and efficacy of CD19 CAR T-cells engineered with a CAR incorporating a fully human scFv (JCAR021) in adults with R/R B-ALL (NCT03103971). Twenty-three patients received lymphodepletion chemotherapy an

SUBMITTER: Gauthier J 

PROVIDER: S-EPMC12008683 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature