RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
Age ≥18 and ≤75
A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
Early active disease
Evidence of significant skin, pulmonary, or cardiac involvement
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 visit
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.
Single group
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 a single dose level following preconditioning with fludarabine and cyclophosphamide
Phase 1/2: To evaluate incidence of adverse events
Incidence and severity of AEs
Phase 2b Sub-study: To evaluate the efficacy of CABA-201 on % predicted forced vital capacity (FVC) in SSc-ILD subjects
Mean change from baseline in % predicted FVC without any immunomodulatory or anti-fibrotic medications and on no or low dose of steroids
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 efficacy
Proportion of subjects achieving revised Composite Response Index for Systemic Sclerosis (CRISS) criteria
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