Adicet Bio has completed the last patient visit for a planned Phase 1 analysis of prulacabtagene leucel, or prula-cel, in people with systemic lupus erythematosus with or without lupus nephritis.
The planned analysis covers 22 patients with at least six months of follow-up, including 13 who have at least 12 months of follow-up. Adicet said it expected to report topline results in September 2026. The Sept. 1 announcement did not include efficacy or safety results from that analysis.
Adicet is also developing a potential registrational trial design for prula-cel following discussions with the U.S. Food and Drug Administration. The company said it expected to provide more detail on the proposed study when it reports the clinical update.
Following alignment with FDA, Adicet has expanded prula-cel administration to outpatient settings for patients with lupus nephritis and other forms of systemic lupus erythematosus in current and future studies. A clinical update on prula-cel in systemic sclerosis is expected in the fourth quarter of 2026.
Separately, FDA cleared Adicet’s investigational new drug application for ADI-212 in August. The company plans to begin enrolling patients with metastatic castration-resistant prostate cancer in a Phase 1 study during the fourth quarter of 2026.
ADI-212 is an off-the-shelf, gene-edited cell-therapy candidate designed for solid tumors. Adicet said the therapy includes an immune-stimulating component intended to affect the tumor microenvironment.
The company is also conducting preclinical work on in vivo CAR-T programs targeting multiple myeloma, non-Hodgkin lymphoma and solid tumors. It expects the first candidate from that portfolio to enter clinical development in the second half of 2027.
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