Gender
All
Age Group
18 Years to 70 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Age ≥18 and ≤70
- 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, renal, or cardiac involvement
Exclusion 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 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.
- 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
- Severe lung or cardiac impairment
- Previous CAR T cell therapy
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell
transplant
Other protocol-defined inclusion/exclusion criteria may apply.