Patient with Systemic Sclerosis is initial dosed in the ongoing Phase 1 clinical trial of ADI-001, a new treatment for autoimmune diseases, by Adicet Bio.
In a recent press release, Adicet Bio, Inc., a clinical-stage biotechnology company specialising in allogeneic gamma delta T cell therapies, announced the progress of its Phase 1 clinical trial for ADI-001 in the treatment of autoimmune diseases. The trial is currently enrolling patients with Systemic Sclerosis (SSc), lupus nephritis (LN), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy, stiff person syndrome, and ANCA-associated vasculitis.
ADI-001, an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy, targets B-cells via an anti-CD20 CAR. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001, with secondary objectives including measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication.
The trial has already dosed the first patients with SSc and LN as of July 2025, and is enrolling patients for other autoimmune indications. Participants receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days, with response and safety assessments conducted on Day 28, followed by longer-term follow-up evaluations at months 3, 6, 9, 12, 18, and 24.
Initial clinical data for lupus nephritis is expected in the first half of 2025, with anticipated preliminary data readouts for ADI-001 more broadly in the second half of 2025. This aligns with updates from the company indicating upcoming data presentations at scientific meetings in mid-2025.
ADI-001 has received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory class III or class IV lupus nephritis (LN), refractory systemic lupus erythematosus (SLE) with extrarenal involvement, and systemic sclerosis (SSc). The FDA's Fast Track designation is given to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.
It is important to note that the press release contains forward-looking statements about the potential safety, tolerability, and efficacy of ADI-001 for the treatment of autoimmune diseases, including Systemic Sclerosis (SSc). These statements are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements.
Adicet Bio is not providing any specific updates on the clinical development of ADI-001 in the given paragraph. The company is also advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), for both autoimmune diseases and cancer.
For more information, please contact Anne Bowdidge at [email protected] or Penelope Belnap at [email protected].
[1] https://www.businesswire.com/news/home/20250724025385/en/ [2] No specific reference provided. [3] No specific reference provided. [4] No specific reference provided.
- Adicet Bio's ongoing Phase 1 trial for ADI-001, a potential treatment for chronic diseases like Systemic Sclerosis (SSc) and lupus nephritis (LN), is focusing on evaluating the therapy's effects on health and wellness, particularly in terms of safety, tolerability, cellular kinetics, pharmacodynamics, and disease activity scores.
- The FDA's Fast Track Designation for ADI-001 signifies its potential to address medical-conditions such as relapsed/refractory class III or IV lupus nephritis, refractory systemic lupus erythematosus with extrarenal involvement, and systemic sclerosis, thus filling an unmet medical need in these areas of science.
