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Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

Join a study for SC291 in severe B-cell autoimmune diseases.

Recruiting
18-75 years
All
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

SC291-102 is a Phase 1 study examining the safety and effects of a new treatment called SC291 for people with severe autoimmune diseases. Autoimmune diseases make the body's immune system attack itself, and this study focuses on conditions like systemic lupus erythematosus (SLE) and anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). SLE can damage organs, and AAV affects blood vessels. In this study, patients will receive one dose of SC291 after being prepared with medicines called cyclophosphamide (CY) and fludarabine (FLU). The treatment aims to help those who have not improved with other therapies. Participants in the study should be between 18 and 75 years of age and must not have had similar cell therapies before.

  • Study involves receiving a single dose of the investigational treatment.
  • Participants must have tried at least two other treatments without success.
  • People with certain brain or nerve issues cannot participate.
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Study details
    Lupus Erythematosus
    Systemic Lupus Erythematosus
    SLE (Systemic Lupus)
    Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
    Granulomatous Polyangiitis
    Microscopic Polyangiitis

NCT06294236

Sana Biotechnology

19 April 2025

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