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/Phase 2

Conditions studied: Systemic Lupus Erythematosus, Lupus Nephritis

In brief

Key facts

Study ID: NCT06121297
Run by: Cabaletta Bio
People needed: 28
Starts: 2024-02-16
Expected to finish: 2029-12-01
Last updated by the study team: 2026-04-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

Clinica Universitaria de Navarra — Pamplona, Navarre, Spain (enrolling)
UC Davis Health — Sacramento, California, United States (enrolling)
Yale University — New Haven, Connecticut, United States (enrolling)
Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada (enrolling)
University of California Irvine — Orange, California, United States (enrolling)
Mayo Clinic — Jacksonville, Florida, United States (enrolling)
Emory University — Atlanta, Georgia, United States (enrolling)
Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
The University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
UMass Memorial Hospital — Worcester, Massachusetts, United States (enrolling)
University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
University of Rochester — Rochester, New York, United States (enrolling)
UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
University of Florida Health — Gainesville, Florida, United States
Columbia University Irving Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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