Adicet reports lupus remissions and prepares pivotal study

Adicet Bio ($ACET) disclosed Phase 1 findings for its off-the-shelf CAR-T therapy prula-cel in systemic lupus erythematosus, with or without lupus nephritis. The efficacy dataset included 22 patients, with 13 followed for at least 12 months. At that point, 54% of evaluable patients met the DORIS remission definition, while 50% of evaluable nephritis patients achieved a complete renal response. All patients had stopped immunosuppressants, although background steroids were not universally discontinued.

The company plans fourth-quarter start-up activities for a pivotal lupus-nephritis study following discussions with the FDA. The results suggest potential for treatment without continuing immunosuppression, but the small, early-stage dataset does not establish comparative effectiveness. Among 24 safety-evaluable patients, infections occurred in 54%, including severe infections in 8.3%; no cytokine-release syndrome above Grade 2 was reported.

Sources:

• Adicet company release — Business Wire / StockTitan