Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial.

ABSTRACT:

Background

Systemic lupus erythematosus (SLE) is a classic systemic autoimmune disease mediated by autoantibodies. Chimeric antigen receptor T (CAR-T) cell therapy, known for its success in cancer, has shown promise in achieving durable B cell depletion and long-term remission in SLE. Relmacabtagene autoleucel (relma-cel) is the second anti-CD19 CAR-T product approved for marketing by the National Medical Products Administration (NMPA) in China and demonstrates its long-term efficacy in relapsed/refractory (r/r) large B cell lymphoma (LBCL). We report the results from a phase I open-label clinical trial of relma-cel in treating patients with moderately to severely active SLE.

Methods

Eligible patients were aged 18-70 years, a ≥6-month history of SLE, and the disease had to r

SUBMITTER: Shu J 

PROVIDER: S-EPMC12083988 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature