ACTIVE_NOT_RECRUITING

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

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Conditions

Lupus ErythematosusSystemic Lupus ErythematosusSLE (Systemic Lupus)Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisGranulomatous PolyangiitisMicroscopic PolyangiitisAutoimmune DiseaseLupus NephritisLupusExtrarenal LupusGranulomatous PolyangitisCAR T Cell TherapyAllogeneicHypoimmuneCD19CyclophosphamideFludarabineCellular TherapySC291ANCA Associated VasculitisSLEANCAVasculitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2024-04-29
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06294236

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 and ≤75
  2. 2. For LN cohort:
  3. * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR)
  4. * Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
  5. * Refractory disease to ≥ 2 prior treatment regimens
  6. 3. For ERL cohort:
  7. * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE
  8. * Severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies
  9. 4. For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria
  1. 1. Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell)
  2. 2. For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder
  3. 3. For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome
  4. 4. For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -

Contacts and Locations

Principal Investigator

Kristen Lee
STUDY_DIRECTOR
Sana Biotechnology, Inc.

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States
Emory University
Atlanta, Georgia, 30322
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Sana Biotechnology

  • Kristen Lee, STUDY_DIRECTOR, Sana Biotechnology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29
Study Completion Date2028-03

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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