Evaluating SC291 for severe autoimmune diseases
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)
This study is testing a new cell therapy called SC291 to see if it is safe and helps people with severe autoimmune diseases like lupus and vasculitis who haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sana Biotechnology Industry-sponsored |
| Drugs / interventions | CAR T, cyclophosphamide, fludarabine |
| Locations | 5 sites (Aurora, Colorado and 4 other locations) |
| Trial ID | NCT06294236 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study aims to assess the safety and tolerability of SC291, an investigational cell therapy, in patients with severe autoimmune diseases such as systemic lupus erythematosus (SLE) and anti-neutrophil cytoplasmic antibody-associated vasculitis. Participants will be divided into cohorts based on their specific conditions, including lupus nephritis and extrarenal lupus, and will have previously shown refractory disease to standard treatments. The study will involve a single dose of SC291 administered after a standard pretreatment regimen. The primary focus is to evaluate preliminary clinical responses and cellular kinetics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with severe systemic lupus erythematosus or anti-neutrophil cytoplasmic antibody-associated vasculitis who have refractory disease.
Not a fit: Patients who have previously received CD19-directed cell therapy or genetically modified cell therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with severe autoimmune diseases that have not responded to existing therapies.
How similar studies have performed: While the approach of using cell therapy for autoimmune diseases is being explored, this specific investigational therapy is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 -
Where this trial is running
Aurora, Colorado and 4 other locations
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Sana Biotechnology, Inc
- Email: Gleam@sana.com
- Phone: (206) 707-9904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.