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
Recruiting now Phase 1/2 NCT06121297
Run by Cabaletta Bio · for 18 to 65 · All sexes
What this study 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
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- Contraindication to leukapheresis
- History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
- Active infection requiring medical intervention at screening
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
- Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
- For LN subjects only: The presence of kidney disease other than active lupus nephritis
- Previous CAR T cell therapy
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
Where this trial is running
- University of California Irvine, Orange, California, United States
- UC Davis Health, Sacramento, California, United States
- Yale University, New Haven, Connecticut, United States
- University of Florida Health, Gainesville, Florida, United States
- Mayo Clinic, Jacksonville, Florida, United States
- Emory University, Atlanta, Georgia, United States
- Northwestern Memorial Hospital, Chicago, Illinois, United States
- The University of Chicago Medical Center, Chicago, Illinois, United States
- University of Kansas Medical Center, Kansas City, Kansas, United States
- Tufts Medical Center, Boston, Massachusetts, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
- Boston Children's Hospital, Boston, Massachusetts, United States
+ 11 more sites.
Who to contact
Cabaletta Bio · 267 759 3100 · clinicaltrials@cabalettabio.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06121297.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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