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

Description

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

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Seattle

Swedish Medical Center, Seattle, Washington, United States, 98122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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 -

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sana Biotechnology,

Paul Brunetta, STUDY_DIRECTOR, Sana Biotechnology, Inc.

Study Record Dates

2028-03