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
Recruiting now · Phase 2/Phase 3
Conditions studied: Idiopathic Inflammatory Myopathy, Dermatomyositis, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing Myopathy, Juvenile Dermatomyositis, Juvenile Polymyositis, Juvenile Idiopathic Inflammatory Myopathy (JIIM), Juvenile Myositis
In brief
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
Key facts
- Study ID
- NCT06154252
- Run by
- Cabaletta Bio
- People needed
- 74
- Starts
- 2023-12-20
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 6 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
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
- 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.
- 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.
Where it is running
- Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients — The Bronx, New York, United States (enrolling)
- Duke University Medical Center - Accepting Young Adults and Juvenile Patients — Durham, North Carolina, United States (enrolling)
- Oregon Health & Science University - Accepting Adult Patients — Portland, Oregon, United States (enrolling)
- Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients — Philadelphia, Pennsylvania, United States (enrolling)
- UPMC Children's Hospital of Pittsburgh - Accepting Juvenile Patients — Pittsburgh, Pennsylvania, United States (enrolling)
- UPMC Arthritis and Autoimmunity Center - Accepting Adult Patients — Pittsburgh, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center - Accepting Adult Patients — Nashville, Tennessee, United States (enrolling)
- University of Texas Southwestern Medical Center - Accepting Juvenile Patients — Dallas, Texas, United States (enrolling)
- Houston Methodist Hospital - Accepting Adult Patients — Houston, Texas, United States (enrolling)
- University of Texas MD Anderson Cancer Center - Accepting Adult Patients — Houston, Texas, United States (enrolling)
- Primary Children's Hospital/University of Utah - Accepting Juvenile Patients — Salt Lake City, Utah, United States (enrolling)
- Seattle Children's Research Institute - Accepting Juvenile Patients — Seattle, Washington, United States (enrolling)
- University of North Carolina at Chapel Hill - Accepting Adult Patients — Chapel Hill, North Carolina, United States (enrolling)
- Kings College Hospital NHS Foundation Trust - Accepting Adult Patients — London, United Kingdom (enrolling)
- University College London Hospitals NHS Foundation Trust - Accepting Adult Patients — London, United Kingdom (enrolling)
- Manchester Royal Infirmary - Accepting Adult Patients — Manchester, United Kingdom (enrolling)
- Salford Royal Hospital - Accepting Adult Patients — Salford, United Kingdom (enrolling)
- University of California Irvine - Accepting Adult Patients — Orange, California, United States (enrolling)
- University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients — San Francisco, California, United States (enrolling)
- Children's Hospital Colorado - Accepting Juvenile Patients — Aurora, Colorado, United States (enrolling)
- Mayo Clinic Florida - Accepting Adult Patients — Jacksonville, Florida, United States (enrolling)
- Johns Hopkins All Children's Hospital - Accepting Juvenile Patients — St. Petersburg, Florida, United States (enrolling)
- Children's Healthcare of Atlanta - Accepting Juvenile Patients — Atlanta, Georgia, United States (enrolling)
- Emory University - Accepting Adult Patients — Atlanta, Georgia, United States (enrolling)
- Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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