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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
- Sana Biotechnology Announces Fast Track Designation for SC291 in Relapsed/Refractory Systemic Lupus Erythematosus. https://www.globenewswire.com/news-release/2024/12/02/2989864/0/en/Sana-Biotechnology-Announces-Fast-Track-Designation-for-SC291-in-Relapsed-Refractory-Systemic-Lupus-Erythematosus.html. Published Dec 2, 2024. Accessed Dec 3, 2024.
- ClinicalTrials.gov. Study Evaluating SC291 in Subjects with Severe R/R B-cell Mediated Autoimmune Diseases (GLEAM). https://clinicaltrials.gov/study/NCT06294236?intr=SC291&rank=1. Updated Nov 7, 2024. Accessed Dec 3, 2024.
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