News & Events zu ADICET Bio, Inc. (ACET)ACETADICET Bio, Inc.

Adicet Bio Completes Last Patient Visit for SLE Trial

Adicet Bio announced completion of the last patient visit for the planned Phase 1 safety and efficacy analysis of prulacabtagene leucel - prula-cel - in patients with systemic lupus erythematosus, or SLE, with or without lupus nephritis. The company expects to report topline data in September 2026. A potential registrational trial design is in development following FDA interaction. The FDA granted clearance of the IND for ADI-212 in metastatic castration-resistant prostate cancer, or mCRPC, and a Phase 1 clinical study is expected to initiate in Q4. The company is advancing a next-generation in vivo CAR-T platform and pipeline targeting hematological malignancies and solid tumors; the first candidate is expected to enter clinical development in 2H 2027.

Adicet Bio's ADI-212 Cleared by FDA

Adicet Bio announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer. The company plans to initiate Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026. "ADI-212 marks an important milestone in Adicet's strategy to address the complexity of solid tumors and represents an important addition to our portfolio of allogeneic gamma delta 1 cell therapies and in vivo CAR T programs," said Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio. "Designed as a single off-the-shelf product, ADI-212 incorporates multiple platform enhancements by combining gene-editing and the expression of novel immune-stimulating molecules intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing and active modulation of tumor microenvironment. The successful IND clearance reinforces our commitment to advancing innovative therapies for patients with cancer."

Adicet Bio Expects Phase 1 Clinical Update for prula-cel in Q3 2026

"At Adicet, we continue to advance prula-cel toward our next important clinical milestone, with a Phase 1 clinical update now expected in the third quarter of 2026. The additional follow-up time will allow us to deliver a more comprehensive and mature dataset, including 22 LN/SLE patients with a minimum of 6 months of follow-up, 13 of whom are expected to have reached at least 12 months of follow-up," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "We also had productive interactions with the FDA to align on overall clinical design for a potential pivotal trial for prula-cel in LN, further supporting a clear regulatory path forward. Furthermore, we anticipate sharing additional clinical updates for prula-cel in the second half of 2026 in patients with systemic sclerosis."