Adicet Bio announced safety and efficacy data from a phase 1 study evaluating prula-cel as a potential treatment for patients with systemic lupus erythematosus (SLE) with or without lupus nephritis (LN).
Prula-cel is an investigational allogeneic gamma delta CAR-T cell therapy targeting B-cells via an anti-CD20 CAR. In the trial, 22 patients (16 LN and 6 extra renal SLE) were evaluated with follow-up ranging from 6-21 months. At the 12-month mark, 50% of evaluable lupus nephritis patients achieved a complete renal response (CRR) and 54% of evaluable patients achieved Definition of Remission in Systemic lupus (DORIS) remission.
Prula-cel was generally well tolerated, with a safety profile supporting outpatient dosing. Among 24 safety-evaluable patients, 25% experienced grade 1 or 2 CRS, with no cases above grade 2. No dose-limiting toxicities (DLTs), immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), or ICANS were reported.
Based on these findings, Adicet plans to initiate start-up activities for a pivotal study in LN in the fourth quarter of 2026. Given the high DORIS remission rate observed in the study, the pivotal study may expand to include lupus patients without nephritis.
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