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
Age ≥18 and ≤65 (Adults) or Age ≥12 to <18 years (Adolescents)
A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for 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
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.
Sequential
CABA-201
Biological/VaccineSingle intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
CABA-201
Biological/VaccineSingle intravenous infusion of CABA-201 at escalating dose levels without preconditioning
To evaluate incidence of adverse events
To evaluate adverse events and laboratory abnormalities
Incidence and severity of AEs, including changes in laboratory values and vital signs
To characterize the pharmacodynamics (PD)
Levels of B cells in the blood
To characterize the pharmacokinetics (PK)
Levels of CABA-201-positive T cells in the blood
To evaluate disease related biomarkers
Levels of C3, C4, and CH50 in serum
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