Cabaletta Bio
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
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 damage in a variety of organs over time. Lupus nephritis (LN) (renal involvement) is a common severe manifestation of SLE, which can lead to significant morbidity and mortality. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, also called resecabtagene autoleucel, or "rese-cel". Rese-cel can be given to patients with either LN or SLE wi…
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: * Contrain…
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning