Adicet reports lupus CAR-T trial data

• Adicet Bio reported Phase 1 data for prulacabtagene leucel (prula-cel) in patients with systemic lupus erythematosus and lupus nephritis.
• At 12 months, 50% of evaluable lupus nephritis patients achieved complete renal response, while 54% achieved DORIS remission.
• Adicet plans to begin preparation for a pivotal lupus nephritis study in the fourth quarter of 2026.

Adicet Bio (NASDAQ:ACET) reported Phase 1 safety and efficacy data for prulacabtagene leucel (prula-cel) in patients with systemic lupus erythematosus with or without lupus nephritis.

The data included 22 efficacy-evaluable patients, consisting of 16 lupus nephritis patients and six extra-renal SLE patients, with follow-up ranging from six to 21 months.

Adicet said that at 12 months, 50% of evaluable lupus nephritis patients achieved complete renal response and 54% of evaluable patients achieved DORIS remission, while the company plans to begin pivotal study preparation in the fourth quarter of 2026.

Adicet Bio develops allogeneic gamma delta CAR-T cell and in vivo CAR-T therapies for autoimmune diseases, blood cancers, and solid tumors.

The company said prula-cel was generally well tolerated among 24 safety-evaluable patients, with no reported cases of ICANS, IEC-HS, or cytokine release syndrome above Grade 2, and that it plans to discuss potential expansion of the pivotal study population with the FDA.