Active — Not RecruitingPhase 1

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

United States7 participantsStarted 2024-04-29

Plain-language summary

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥18 and ≤75
✓. For LN cohort:
✓. For ERL cohort:
✓. For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria

Exclusion criteria

✕. Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell)
✕. For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder
✕. For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome
✕. For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -

What they're measuring

Evaluate safety and tolerability of SC291

Timeframe: 24 months

Trial details

NCT IDNCT06294236

SponsorSana Biotechnology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

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