Investigational Therapy SC291 Receives FDA Fast Track Designation for Relapsed/Refractory Systemic Lupus Erythematosus
The U.S Food and Drug Administration (FDA) granted Fast Track Designation to Sana Biotechnology’s SC291 for relapsed/refractory systemic lupus erythematosus (SLE) treatment. SC291 is a hypoimmune (HIP)-modified CD19-directed allogeneic CAR T cell therapy. This investigational therapy uses T cells from healthy donors to generate CAR T cells that target CD19, a protein found on the cell surface of B cells.
Sana is currently enrolling individuals with B cell mediated autoimmune disease including lupus nephritis (LN), extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis in the GLEAM trial. Initial data is expected in 2025.
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