Status:
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
Lead Sponsor:
Cabaletta Bio
Conditions:
Systemic Lupus Erythematosus
Lupus Nephritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by autoantibody production and abnormal B cell function. SLE presents with fluctuating severity and may cause tissue d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06121297
Start Date
February 16 2024
End Date
December 1 2029
Last Update
December 11 2025
Active Locations (23)
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1
University of California Irvine
Orange, California, United States, 92868
2
UC Davis Health
Sacramento, California, United States, 95817
3
Yale University
New Haven, Connecticut, United States, 06520
4
University of Florida Health
Gainesville, Florida, United States, 32610