Adicet Bio, Inc. has dosed the first patient in a Phase 1 clinical trial evaluating ADI-001 for the treatment of autoimmune diseases, with an initial focus on lupus nephritis (LN). This marks a significant step in the development of a potential new therapy for this challenging condition.
The Phase 1 study is designed with four arms, each targeting different autoimmune conditions: LN and systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS), and ANCA-associated vasculitis (AAV). Patients enrolled in the trial will receive a single dose of ADI-001, with a 28-day dose-limiting toxicity window. Response and safety assessments will be conducted on Day 28 and during follow-up periods at months 3, 6, 9, 12, 18, and 24.
FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for relapsed or refractory class III or IV lupus nephritis. This designation is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The FDA also cleared the Investigational New Drug (IND) amendment for stiff person syndrome and idiopathic inflammatory myopathy treatment.
ADI-001: Mechanism of Action
ADI-001 is an investigational allogeneic gamma delta CAR T-cell therapy targeting B-cells via an anti-CD20 CAR. Preclinical data has demonstrated complete CD19+ B cell depletion in peripheral blood and secondary lymphoid tissue in non-Hodgkin’s lymphoma, suggesting a promising mechanism of action for autoimmune diseases.
Clinical Trial Objectives and Enrollment
The primary objectives of the Phase 1 study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and relevant disease activity scores for each indication.
Enrollment for SLE, SSc, IIM, and SPS patients is expected to begin in the first quarter of 2025, with AAV patient enrollment anticipated in the second half of 2025. Preliminary clinical data from the lupus nephritis arm of the trial is expected in the first half of 2025.
Management Commentary
"Dosing the first lupus nephritis patient in our Phase 1 trial of ADI-001 marks an important step forward in our mission of improving the lives of patients affected by autoimmune diseases, particularly lupus nephritis," said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. He added that ADI-001 has the potential to be a transformative off-the-shelf treatment option for several autoimmune diseases, emphasizing the urgent need for approved therapies in this area.
