Adicet Bio finishes final patient visits in lupus CAR-T study, plans September data
The company also disclosed FDA clearance of an IND for a new solid tumor cell therapy and outlined plans for an in vivo CAR-T pipeline.
Adicet Bio, Inc. announced on September 1, 2026 that it completed the last patient visit for a planned Phase 1 safety and efficacy analysis of prulacabtagene leucel (prula-cel) in patients with systemic lupus erythematosus, with or without lupus nephritis.1 The company said it expects to report topline data in September 2026,1 and plans to hold an investor webcast once that data is released to walk through results and next steps.1
The analysis draws on 22 SLE patients, with or without lupus nephritis, each followed for at least six months; 13 of those patients have at least a year of follow-up data.1 Adicet also said it is developing a potential registrational trial design after discussions with the FDA, with more detail expected alongside the upcoming clinical update.1 Separately, the company noted it has expanded prula-cel dosing to the outpatient setting following alignment with the FDA, covering lupus nephritis and other SLE patients in current and future studies.1 A systemic sclerosis update is expected in the fourth quarter of 2026.1
On the oncology side, the FDA cleared Adicet's IND for ADI-212, a treatment candidate for metastatic castration-resistant prostate cancer, in August 2026.1 The company plans to begin enrollment in the fourth quarter of 2026.1 ADI-212 is described as an off-the-shelf, gene-edited cell therapy designed with an added immune-stimulating molecule meant to improve tumor targeting, durability of tumor killing, and modulation of the tumor microenvironment.1
Adicet is also building out an in vivo CAR-T platform, with preclinical work in multiple myeloma, non-Hodgkin's lymphoma, and solid tumor indications,1 and the company expects its first candidate from that portfolio to reach clinical development in the second half of 2027.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.