RecruitingIdiopathic Inflammatory MyopathyDermatomyositisAnti-Synthetase Syndrome

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

Eligible age

6–75 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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

Sponsor: Cabaletta Bio

You may qualify if…

✓ Age ≥18 and ≤75
✓ A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria
✓ Diagnosis of DM, ASyS, or IMNM
✓ Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography
✓ Presence of muscle weakness
✓ Other protocol-defined criteria apply.
✓ Age ≥6 and ≤17 years at enrollment
✓ A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria

You may not qualify if…

✕ 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