A Phase 1/2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Age ≥18 and ≤65
• A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE.
• Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.
• For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
• For non-renal SLE subjects only: Active, moderate to severe SLE
Locations
United States
California
University of California Irvine
RECRUITING
Orange
UC Davis Health
RECRUITING
Sacramento
Connecticut
Yale University
RECRUITING
New Haven
Florida
University of Florida Health
ACTIVE_NOT_RECRUITING
Gainesville
Mayo Clinic
RECRUITING
Jacksonville
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
The University of Chicago Medical Center
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
UMass Memorial Hospital
RECRUITING
Worcester
Minnesota
University of Minnesota
RECRUITING
Minneapolis
North Carolina
UNC Chapel Hill
RECRUITING
Chapel Hill
New York
Columbia University Irving Medical Center
WITHDRAWN
New York
University of Rochester
RECRUITING
Rochester
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Canada
Maisonneuve-Rosemont Hospital
RECRUITING
Montreal
Spain
Clinica Universitaria de Navarra
RECRUITING
Pamplona
Contact Information
Primary
Cabaletta Bio
clinicaltrials@cabalettabio.com
267 759 3100
Time Frame
Start Date: 2024-02-16
Estimated Completion Date: 2029-12
Participants
Target number of participants: 28
Treatments
Experimental: CABA-201 with FLU/CY Preconditioning
LN Cohort: Infusion of CABA-201 with preconditioning in subjects with LN~Non-renal SLE Cohort: Infusion of CABA-201 with preconditioning in subjects with non-renal SLE who do not meet criteria for inclusion in the LN cohort~Expansion Cohort: Infusion of CABA-201 with preconditioning in subjects with LN and SLE
Experimental: CABA-201, No Preconditioning
Infusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE
Related Therapeutic Areas
Sponsors
Leads: Cabaletta Bio