NCT06294236Active, not recruitingPhase 1
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
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)
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- First submitted
- 12 Feb 2024
- Start date
- 29 Apr 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Sana Biotechnology
- Diseases
- Lupus (SLE), ANCA-associated vasculitis
- NCT number
- NCT06294236
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 7
- From 29 Apr 2024 to the primary completion date, 31 Dec 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell)
Other illness
- 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
Other
- For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -
Who the study is looking for
- Age ≥18 and ≤75
- 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
- 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
- For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.