"Adicet Bio administers initial treatment of Systemic Sclerosis patient in progressing Phase 1 trial for ADI-001 in autoimmune disorders"
Adicet Bio's Phase 1 Trial for Autoimmune Diseases Advances
Adicet Bio, Inc., a clinical-stage biotechnology company, is progressing with a Phase 1 clinical trial for its investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy, ADI-001. This trial is focused on autoimmune diseases, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), inclusion body myositis (IIM), Sjogren's syndrome (SPS), and antibody-associated vasculitis (AAV).
The trial, currently active and enrolling patients, has four separate arms: one for LN and SLE patients, one for SSc patients, one for IIM and SPS patients, and one for AAV patients. Each patient receives a single dose of ADI-001, which targets B-cells via an anti-CD20 CAR.
The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. A 28-day dose-limiting toxicity window follows dosing, with safety and response assessments conducted on Day 28. Follow-up visits are scheduled at months 3, 6, 9, 12, 18, and 24.
Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody levels, and disease activity scores in each indication.
ADI-001 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory class III or class IV lupus nephritis, refractory SLE with extrarenal involvement, and SSc.
Preliminary clinical data from this Phase 1 trial are expected in the second half of 2025, indicating that initial safety and tolerability results will soon be made available.
Adicet Bio, Inc. is committed to discovering and developing allogeneic gamma delta T cell therapies for both autoimmune diseases and cancer. However, it is important to note that the company's forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.
[1] Adicet Bio, Inc. (2025). [Press Release: Adicet Bio Initiates Phase 1 Trial of ADI-001 in Autoimmune Diseases]. Retrieved from https://www.adicetbio.com/news-and-events/press-releases/detail/109/adicet-bio-initiates-phase-1-trial-of-adi-001-in-autoimmune-diseases
[3] Adicet Bio, Inc. (2025). [Press Release: Adicet Bio Doses First Systemic Sclerosis Patient in Phase 1 Trial of ADI-001]. Retrieved from https://www.adicetbio.com/news-and-events/press-releases/detail/110/adicet-bio-doses-first-systemic-sclerosis-patient-in-phase-1-trial-of-adi-001
[4] Adicet Bio, Inc. (2025). [Investor Presentation: Adicet Bio, Inc.]. Retrieved from https://www.adicetbio.com/investors/events-presentations
[5] U.S. Food and Drug Administration (2023). [Fast Track Designation]. Retrieved from https://www.fda.gov/for-industry/product-approval-and-marketing/fast-track-designation
The Phase 1 clinical trial by Adicet Bio is specifically designed for autoimmune diseases, encompassing medical conditions such as lupus nephritis, systemic lupus erythematosus, systemic sclerosis, inclusion body myositis, Sjogren's syndrome, and antibody-associated vasculitis. This trial, focusing on health and wellness, aims to assess the safety and tolerability of ADI-001, an allogeneic gamma delta chimeric antigen receptor T cell therapy.
Adicet Bio's commitment in developing ADI-001 extends beyond autoimmune diseases, as they aim to explore potential applications in cancer treatments as well. However, it is crucial to acknowledge that their forward-looking statements about the therapy are subject to various risks and uncertainties that may influence the final outcomes.
