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U.S. FDA grants fast track designation for CD19-directed CAR T-cell therapy SC291
On December 2, 2024, the U.S. Food and Drug Administration (FDA) granted fast track designation to expedite clinical development and regulatory review timelines for SC291, a hypoimmune-modified CD19-directed allogeneic chimeric antigen receptor (CAR) T-cell therapy, in relapsed/refractory (R/R) systemic lupus erythematosus, including extrarenal lupus and lupus nephritis.1
SC291 is currently being investigated in the phase I GLEAM trial (NCT06294236) to evaluate its safety and tolerability, preliminary clinical response, cellular kinetics, and exploratory analyses in patients with severe R/R B-cell mediated autoimmune diseases.1,2 Initial clinical data is anticipated to be reported in 2025.1,2
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