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Investigational Therapy SC291 Receives FDA Fast Track Designation for Relapsed/Refractory Systemic Lupus Erythematosus

by | Dec 5, 2024

Inside Lupus Research (ILR): Treatment News

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. 

Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about medications used to treat lupus.

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