Adicet Bio Reports Phase 1 Study Results for Investigational CAR-T Therapy in Lupus
A Phase I study of the investigational CAR-T cell therapy prulacabtagene leucel (prula-cel) found that some people with systemic lupus erythematosus (SLE), including those with lupus nephritis (LN), achieved remission and kidney-related responses after a single treatment. Adicet Bio, a clinical-stage biotechnology company, is developing prula-cel and recently announced the preliminary results using data collected through August 28, 2026.
The study included 22 people whose treatment responses could be evaluated: 16 with lupus nephritis and six with SLE affecting organs outside the kidneys. All had received at least three prior therapies. Among people with 12 months of follow-up, 50% of those with LN achieved a complete renal response and 54% achieved Definition of Remission in SLE (DORIS) remission. The company also reported that all study participants discontinued immunosuppressants, while all but one reduced background steroids to 5mg or less of prednisone equivalent.
Adicet Bio plans to begin start-up activities for an LN study in Q4 of 2026, with potential expansion to include SLE without nephritis subject to regulatory alignment.
CAR T-cell therapies are approved by the U.S Food and Drug Administration (FDA) to treat specific blood cancers and certain tumors. Since 2021, researchers have also investigated CAR-T cell therapies for severe, treatment resistant lupus in clinical trials. People considering a clinical trial should discuss the specific therapy and study protocol with their healthcare team and understand the potential benefits and risks.