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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

Join a study testing CABA-201 for inflammatory muscle conditions.

Recruiting
6-75 years
All
Phase 1/2

RESET-Myositis is a study for people with a rare muscle disease called idiopathic inflammatory myopathy (IIM), which involves muscle weakness and inflammation. The exact cause of IIM is unknown, but it might involve the body's immune cells, like B cells, attacking muscles. This study tests a new treatment called CABA-201, given with drugs cyclophosphamide and fludarabine, to see if it helps people with active IIM or juvenile IIM (JIIM). All participants receive one dose of this new treatment.

Key Points:

  • Participants must be 6-75 years old with active IIM or JIIM, even after standard treatments.
  • Exclusions include severe heart, lung, or other major health issues, or having had certain prior treatments.
  • The study aims to check if CABA-201 is safe and effective, but participating involves medical evaluations and potential risks.
Study details
    Idiopathic Inflammatory Myopathy
    Dermatomyositis
    Anti-Synthetase Syndrome
    Immune-Mediated Necrotizing Myopathy
    Juvenile Dermatomyositis
    Juvenile Polymyositis
    Juvenile Idiopathic Inflammatory Myopathy (JIIM)
    Juvenile Myositis

NCT06154252

Cabaletta Bio

11 May 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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