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# Adicet Wins Fast Track for Lupus Cell Therapy
- URL: https://www.fdaweb.com/adicet-wins-fast-track-for-lupus-cell-therapy/
- Published: 2025-02-07T12:00:00.000Z
- Updated: 2026-09-14T14:52:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158624

FDA has granted Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. ADI-001 is described as an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for treating autoimmune diseases. Previously, the CAR T cell therapy was granted fast track status for treating relapsed/refractory Class 3 or Class 4 lupus nephritis (LN).

The company says ADI-001 is being advanced across six autoimmune indications. For example, patient enrollment is ongoing in a Phase 1 study evaluating it for treating LN. Patient enrollment in SLE, systemic sclerosis, idiopathic inflammatory myopathy, and stiff person syndrome is expected to be initiated by April, it says.