RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

Inclusion Criteria:

• Age ≥18 and ≤75

• A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology andEuropean League Against Rheumatism classification criteria.

• Early active disease

• Evidence of significant skin, pulmonary, renal, or cardiac involvement

Exclusion Criteria:

• Contraindication to leukapheresis

• History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamideor 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, orcerebral disease, including severe and uncontrolled infections, such as sepsis andopportunistic infections.

• Concomitant medical conditions that, in the opinion of the investigator, might placethe subject at unacceptable risk for participation in this study, interfere with theassessment of the effects or safety of the investigational product or with the studyprocedures

• Severe lung or cardiac impairment

• Previous CAR T cell therapy

• Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic celltransplant

Other protocol-defined inclusion/exclusion criteria may apply.