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
Condition(s) studied
Lupus ErythematosusSystemic Lupus ErythematosusSLE (Systemic Lupus)Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisGranulomatous PolyangiitisMicroscopic Polyangiitis
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
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)
- Evaluate safety and tolerability of SC291 — 24 months
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID)
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Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
Active, not recruiting
Other trials for the same condition
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Active, not recruiting
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