Adicet Bio advances CAR-T therapy programs

• Adicet Bio completed the last patient visit for its Phase 1 prula-cel study in lupus patients.
• The FDA cleared the IND application for ADI-212 in metastatic castration-resistant prostate cancer.
• The company expects its first in vivo CAR-T candidate to enter clinical development in the second half of 2027.

Adicet Bio (NASDAQ:ACET) completed the last patient visit for the planned Phase 1 safety and efficacy analysis of prulacabtagene leucel (prula-cel) in patients with systemic lupus erythematosus with or without lupus nephritis.

The company expects to report topline prula-cel data in September 2026 from an analysis including 22 patients with at least six months of follow-up, including 13 patients with at least 12 months of follow-up.

Adicet Bio said it received FDA clearance for the Investigational New Drug application for ADI-212, a gene-edited cell therapy candidate being developed for metastatic castration-resistant prostate cancer, with Phase 1 enrollment expected to begin in the fourth quarter of 2026.

The company is also advancing its in vivo CAR-T platform, with a first candidate expected to enter clinical development in the second half of 2027.

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

The company’s pipeline includes programs focused on systemic lupus erythematosus, metastatic prostate cancer, multiple myeloma, non-Hodgkin’s lymphoma, and other solid tumor indications.