NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06121297

RecruitingPhase 1, Phase 2

Sponsor: Cabaletta Bio

Conditions: Systemic Lupus Erythematosus, Lupus Nephritis

Interventions: CABA-201, CABA-201

Countries: United States, Canada, Spain

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Locations (23)

Orange, California, United States
Sacramento, California, United States
New Haven, Connecticut, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Montreal, Quebec, Canada
Pamplona, Navarre, Spain