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A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Subjects With Severe Relapsed or Refractory Autoimmune Diseases (GLEAM)

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Trial Profile

A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Subjects With Severe Relapsed or Refractory Autoimmune Diseases (GLEAM)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Apr 2025

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At a glance

  • Drugs SC 291 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Anti-neutrophil cytoplasmic antibody-associated vasculitis; Autoimmune disorders; Granulomatosis with polyangiitis; Lupus nephritis; Microscopic polyangiitis; Systemic lupus erythematosus
  • Focus Adverse reactions
  • Acronyms GLEAM
  • Sponsors Sana Biotechnology

    • Most Recent Events

    • 02 Dec 2024 According to Sana Biotechnology media release, company is enrolling patients in this study and expects to share initial data in 2025.
    • 02 Dec 2024 According to Sana Biotechnology media release, company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for SC291 in relapsed/refractory systemic lupus erythematosus (SLE), which includes extrarenal lupus and lupus nephritis.
    • 04 Nov 2024 According to Sana Biotechnology media release, the company expects to share clinical data in 2024 and/or 2025.

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