Adicet Begins ADI-001 Phase 1 Trial Enrollment for Autoimmune Diseases

Adicet Bio, Inc., a clinical-stage biotechnology firm focusing on innovative treatments for autoimmune diseases and cancer, has announced the commencement of patient enrollment for its Phase 1 clinical trial of ADI-001. This trial aims to explore the potential of ADI-001 in treating multiple autoimmune conditions, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV).

According to Francesco Galimi, M.D., Ph.D., the Senior Vice President and Chief Medical Officer at Adicet Bio, ADI-001 has shown promising results in terms of safety, cellular kinetics, and B cell depletion in both peripheral blood and secondary lymphoid tissues. These findings indicate that ADI-001 may revolutionize the treatment landscape for autoimmune diseases. Dr. Galimi mentioned that several more sites are expected to commence patient enrollment by the end of the fourth quarter of 2024, with an increasing number of sites becoming active in the first quarter of 2025. Currently, the focus is on enrolling patients with LN, while the enrollment for SLE, SSc, and AAV is anticipated to start in the last quarter of 2024. Preliminary clinical data from these trials are expected to be available by the first half of 2025.

This initiative follows the U.S. Food and Drug Administration's (FDA) decision to grant Fast Track Designation to ADI-001 for the treatment of relapsed or refractory class III or class IV LN. Additionally, the FDA has cleared the way for the development of ADI-001 in four autoimmune indications: LN, SLE, SSc, and AAV.

The Phase 1 clinical trial is structured into three distinct arms: one for LN and SLE patients, another for SSc patients, and the third for AAV patients. Participants will receive a single dose of ADI-001, and the dose-limiting toxicity period is set at 28 days. Response and safety assessments will occur on Day 28 and will continue during follow-up periods at months 3, 6, 9, 12, 18, and 24. The primary goals of the study include evaluating the safety and tolerability of ADI-001. Secondary objectives focus on cellular kinetics, pharmacodynamics, changes in autoantibody levels, and appropriate disease activity scores for each condition.

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy designed to target B-cells through an anti-CD20 CAR. The FDA has already granted Fast Track Designation to ADI-001 for the potential treatment of relapsed or refractory class III or class IV lupus nephritis and relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).

Adicet Bio, Inc. is dedicated to advancing a pipeline of "off-the-shelf" gamma delta T cells, which are engineered with chimeric antigen receptors (CARs) to ensure durable efficacy in patients. These advancements aim to offer new therapeutic options for individuals suffering from autoimmune diseases and various forms of cancer.