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

NCT06294236 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SC291-102
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Lupus Erythematosus; Systemic Lupus Erythematosus; SLE (Systemic Lupus); Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granulomatous Polyangiitis; Microscopic Polyangiitis

Keywords

Autoimmune Disease; Systemic Lupus Erythematosus; Lupus Nephritis; Lupus; Extrarenal Lupus; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granulomatous Polyangitis; Microscopic Polyangiitis; CAR T Cell Therapy; Allogeneic; Hypoimmune; CD19; Cyclophosphamide; Fludarabine; Cellular Therapy; SC291; ANCA Associated Vasculitis; SLE; ANCA; Vasculitis

Outcome Measures

Primary Outcomes (1)

• Evaluate safety and tolerability of SC291

  Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

  24 months

Secondary Outcomes (10)

• Evaluate preliminary clinical response to SC291

  12 months

• Evaluate preliminary clinical response to SC291

  12 months

• Evaluate preliminary clinical response to SC291

  12 months

• Evaluate preliminary clinical response to SC291

  12 months

• Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts)

  12 months

Study Arms (3)

LN Cohort

EXPERIMENTAL

SC291 with lymphodepleting therapy

Biological: SC291

ERL Cohort

EXPERIMENTAL

SC291 with lymphodepleting therapy

Biological: SC291

AAV Cohort

EXPERIMENTAL

SC291 with lymphodepleting therapy

Biological: SC291

Interventions

SC291 BIOLOGICAL

SC291 is an allogeneic CAR T cell therapy

Also known as: Cyclophosphamide, Fludarabine

AAV Cohort; ERL Cohort; LN Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell)
• 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
• For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -

Sponsors & Collaborators

• Sana Biotechnology: lead

Study Sites (5)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Autoimmune Diseases; Lupus Nephritis; Vasculitis

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Kristen Lee

  Sana Biotechnology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 5, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (5)