Adicet Bio Announces Positive Phase 1 Results for ADI-001 in Lupus Nephritis and SLE, Plans Pivotal Phase 2 Trial in 2026

Adicet Bio Inc. (Nasdaq: ACET) has announced positive preliminary data from its ongoing Phase 1 clinical trial evaluating ADI-001, an allogeneic gamma delta T cell therapy, in patients with lupus nephritis (LN) and systemic lupus erythematosus $(SLE)$. As of the August 31, 2025 data cut-off, all seven evaluable patients demonstrated rapid and sustained reductions in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician's Global Assessment (PGA). Among the five LN patients, three achieved complete renal responses and DORIS remissions, while two showed partial renal responses, with all responses ongoing. The therapy was generally well tolerated, with no cases of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or Grade 2 or higher Cytokine Release Syndrome $(CRS)$ observed. All patients were able to discontinue immunosuppressants and reduce corticosteroid use to physiological levels. Adicet Bio plans to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to discuss pivotal Phase 2 trial design, with study initiation anticipated in the second quarter of 2026. The company will present these results in a webcast scheduled for Tuesday, October 7 at 8:00am ET.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Adicet Bio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251006091236) on October 07, 2025, and is solely responsible for the information contained therein.