Biotechnology company Adicet Bio Inc (Nasdaq: ACET) announced on Wednesday that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for ADI-001, an investigational allogeneic gamma delta CAR T cell therapy targeting CD20, for the treatment of refractory systemic lupus erythematosus (SLE) with extrarenal involvement.

The designation is intended to expedite the development and review of treatments for serious conditions with unmet medical needs. ADI-001 is also under development for lupus nephritis and is being advanced across six autoimmune indications, including systemic sclerosis, myositis and stiff person syndrome, with multiple Phase 1 studies expected to commence in 2025.

Preliminary findings from the GLEAN trial showed ADI-001 achieved complete CD19+ B-cell depletion in peripheral blood and lymphoid tissues, demonstrating robust therapeutic potential.

Adicet Bio specializes in developing "off-the-shelf" gamma delta T cell therapies, harnessing chimeric antigen receptors (CARs) to address autoimmune diseases and cancer.