RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis

Prior treatment

• 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
• Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
  • Other protocol-defined inclusion/exclusion criteria may apply.

Other illness

• 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.
• Significant lung or cardiac impairment

Other

• Contraindication to leukapheresis

• Age ≥18 and ≤70 years of age
• Diagnosis of MG with generalized muscle weakness meeting criteria as defined by the MGFA class II, III , IVa, and IVb.
• Diagnosis of seropositive (autoantibodies AChR, MuSK and/or LRP4) or seronegative MG