Actively Recruiting
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
Led by Cabaletta Bio · Updated on 2026-04-09
28
Participants Needed
23
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Clinical diagnosis of systemic lupus erythematosus (SLE) based on 2019 EULAR/ACR criteria
- Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening
- For lupus nephritis subjects: active, biopsy-proven LN class III or IV, with or without class V
- For non-renal SLE subjects: active moderate to severe SLE
You will not qualify if you...
- Contraindication to leukapheresis
- History of anaphylactic or severe reaction to fludarabine, cyclophosphamide, or their metabolites
- Active infection requiring medical intervention at screening
- Severe, progressive, or uncontrolled disease in renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral systems
- Medical conditions that increase risk or interfere with study procedures
- For lupus nephritis subjects: kidney disease other than active lupus nephritis
- Previous CAR T cell therapy
- Prior solid organ or hematopoietic cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
2
UC Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
University of Florida Health
Gainesville, Florida, United States, 32610
Active, Not Recruiting
5
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
8
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
9
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
10
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
11
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
12
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
13
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
14
UMass Memorial Hospital
Worcester, Massachusetts, United States, 01655
Actively Recruiting
15
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
16
Columbia University Irving Medical Center
New York, New York, United States, 10032
Withdrawn
17
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
18
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
19
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
21
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
22
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
23
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
C
Cabaletta Bio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here