Status:
RECRUITING
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
Lead Sponsor:
Cabaletta Bio
Conditions:
Idiopathic Inflammatory Myopathy
Dermatomyositis
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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
Detailed Description
Idiopathic inflammatory myopathies (IIMs, or myositis) are a group of rare autoimmune diseases characterized by inflammation and muscle weakness. Though the cause of IIM is not well understood, some s...
Eligibility Criteria
Inclusion
- Adult Cohorts
- 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, 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.
Exclusion
- 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
- Inclusion Criteria:
- 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
- Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography
- Other protocol-defined criteria apply.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06154252
Start Date
December 20 2023
End Date
July 1 2028
Last Update
October 22 2025
Active Locations (25)
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1
University of California Irvine - Accepting Adult Patients
Orange, California, United States, 92868
2
University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients
San Francisco, California, United States, 94158
3
Children's Hospital Colorado - Accepting Juvenile Patients
Aurora, Colorado, United States, 80046
4
Mayo Clinic Florida - Accepting Adult Patients
Jacksonville, Florida, United States, 32224