Adicet Bio Doses First Lupus Nephritis Patient in ADI-001 Phase 1 Autoimmune Trial

Adicet Bio, Inc., a biotechnology company based in Redwood City, CA, and Boston, MA, is making significant strides in the development of allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. On November 18, 2024, Adicet Bio announced that they have dosed the first lupus nephritis (LN) patient in their Phase 1 clinical trial evaluating ADI-001 for autoimmune diseases.

Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Adicet Bio, emphasized the importance of this milestone. He stated that dosing the first LN patient in the Phase 1 trial signifies a crucial step in their mission to improve the lives of patients suffering from autoimmune diseases, particularly lupus nephritis. Dr. Galimi highlighted ADI-001's potential as a transformative off-the-shelf treatment for various autoimmune diseases. This is supported by clinical biomarker data from their study in non-Hodgkin’s lymphoma, which showed strong tissue trafficking and complete CD19+ B cell depletion in both peripheral blood and secondary lymphoid tissue.

The Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. Furthermore, the FDA has cleared Adicet Bio’s investigational new drug (IND) amendment application for ADI-001 to treat stiff person syndrome (SPS) and idiopathic inflammatory myopathy (IIM). These regulatory advancements underscore the urgent need for approved therapies to address autoimmune diseases.

Dr. Galimi also mentioned that clinical sites are currently open for enrollment and additional sites are expected to open soon. Preliminary clinical data from the trial is anticipated in the first half of 2025. Additionally, patient enrollment for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), IIM, and SPS is expected to begin in the first quarter of 2025, while enrollment for patients with anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) is expected in the second half of 2025.

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy that targets B-cells via an anti-CD20 CAR. The Phase 1 clinical trial comprises four separate arms. One arm includes LN and SLE patients, another arm includes SSc patients, the third arm includes IIM and SPS patients, and the fourth arm includes AAV patients. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days, with response and safety assessments conducted on Day 28 and during follow-up periods at months 3, 6, 9, 12, 18, and 24. The primary objectives of the study are to assess the safety and tolerability of ADI-001. Secondary objectives include evaluating cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores for each indication.

Adicet Bio, Inc. is dedicated to discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Their pipeline includes "off-the-shelf" gamma delta T cells that are engineered with chimeric antigen receptors (CARs) to ensure durable activity in patients. Adicet Bio continues to advance its clinical programs with the goal of providing new treatment options for patients with unmet medical needs.