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Clinical Trials in the USA / NCT06294236
Active, not recruiting Phase 1

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

NCT06294236 · tracked via the Priya Life Science USA tracker
Sponsor
Sana Biotechnology
Phase
Phase 1
Started
2024-04-29
Last updated
2025-11-25

Condition(s) studied

Lupus ErythematosusSystemic Lupus ErythematosusSLE (Systemic Lupus)Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisGranulomatous PolyangiitisMicroscopic Polyangiitis

Investigational drug(s) / intervention(s)

SC291

SC291: SC291 is an allogeneic CAR T cell therapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 and ≤75 2. For LN cohort: * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) * Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria * Refractory disease to ≥ 2 prior treatment regimens 3. For ERL cohort: * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE * Severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies 4. For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria Exclusion Criteria: 1. Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell) 2. For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder 3. For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome 4. For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
University of Colorado Aurora Colorado
Emory University Atlanta Georgia
Johns Hopkins Hospital Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Swedish Medical Center Seattle Washington

More Sana Biotechnology trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06294236 on ClinicalTrials.gov ↗ ← All trials in the USA