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

Launched by SANA BIOTECHNOLOGY · Feb 27, 2024

Keywords

ClinConnect Summary

The GLEAM trial is a research study looking at a new treatment called SC291 for people with severe autoimmune diseases, such as lupus and certain types of vasculitis. This Phase 1 trial aims to understand how safe SC291 is, how well it works, and how it affects the body’s immune cells. The study is currently recruiting participants aged 18 to 75 who have specific types of lupus or related conditions that have not responded well to previous treatments.

To be eligible for this study, participants must have been diagnosed with systemic lupus erythematosus (SLE) and have severe symptoms that haven’t improved with at least two other therapies. Those with specific kidney-related lupus or certain types of vasculitis may also qualify. If you join the study, you will receive SC291 and be monitored by medical professionals to track your health and any side effects. This trial is an important step in finding new options for people struggling with these challenging conditions.

Gender

ALL

Eligibility 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 -