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Adicet Bio Announces Safety and Efficacy Data for Systemic Lupus Treatment
Adicet Bio announced safety and efficacy data from the Phase 1 study evaluating prulacabtagene leucel as a potential treatment for patients with systemic lupus erythematosus with or without lupus nephritis. The data cut as of August 28, 2026 includes 22 efficacy evaluable patients (16 LN patients and 6 extra-renal SLE patients). All patients have follow-up of at least 6 months, and 13 patients have at least 12 months of follow-up. Based on these findings, the company plans to initiate start-up activities for a pivotal study in LN in the fourth quarter of 2026. Given the high Definition of Remission in Systemic lupus remission rate observed in the study, the pivotal study may expand to include lupus patients without nephritis. Highlights: Prula-cel shown to be generally well tolerated with no CRS greater than Grade 2 and no IEC-HS or ICANS; At 12-months, 54% of evaluable patients achieved DORIS remission and 50% of patients achieved CRR; All patients discontinued immunosuppressants; All but one patient tapered background steroids to less than or equal to5 mg prednisone equivalent per day; Rapid reductions in SLEDAI-2K and PGA scores, consistent with autologous alpha beta CAR-T cell therapies; Plan to initiate pivotal lupus nephritis trial start-up activities in 4Q/2026; high DORIS remission rate may support expansion of pivotal study to include lupus without nephritis based on regulatory precedent.
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."
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