RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

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
• •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
• •Significant lung or cardiac impairment
• •Previous CAR T cell therapy
• •Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
• •Other protocol-defined criteria apply.
• •Juvenile Cohort
• •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
• •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
• •Significant lung or cardiac impairment
• •Previous CAR T cell therapy
• •Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
• •Other protocol-defined criteria apply.