ADI-001 + cyclophosphamide

ADI-001 + cyclophosphamide is an investigational combination regimen comprised of **ADI-001**, a first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy targeting CD20, and **cyclophosphamide**, a chemotherapeutic alkylating agent commonly used for lymphodepletion. **ADI-001** is engineered from γδ T cells and expresses a CAR specific for CD20, enabling it to recognize and kill malignant or pathogenic B cells by combining innate and adaptive cytotoxic effector mechanisms. This therapy is MHC-independent, reducing the risk of graft-versus-host disease. The combination is typically used in clinical trials where cyclophosphamide, often together with fludarabine, is administered as conditioning therapy prior to infusion of ADI-001 to promote CAR-T cell engraftment and activity. Key indications in development include relapsed/refractory B-cell lymphomas (such as large B-cell lymphoma and mantle cell lymphoma) and several autoimmune diseases (including lupus nephritis, systemic lupus erythematosus, systemic sclerosis, and ANCA-associated vasculitis). The regimen is investigational and not yet approved for any indication[1][3][4][5][7][10].