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
Part of paid clinical trials in Orange, California.
- Sponsor
- Cabaletta Bio
- Study ID
- NCT06154252
- Phase
- PHASE2/PHASE3
- Status
- Recruiting
Conditions
- Anti-Synthetase Syndrome
- Dermatomyositis
- Idiopathic Inflammatory Myopathy
- Immune-Mediated Necrotizing Myopathy
- Juvenile Dermatomyositis
- Juvenile Idiopathic Inflammatory Myopathy (JIIM)
- Juvenile Myositis
- Juvenile Polymyositis
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- CABA-201 following preconditioning with fludarabine and cyclophosphamide — BIOLOGICALSingle intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Study Details
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 Dates
- Start date
- Dec 20, 2023
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 74 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CABA-201 Phase 1/2DM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with DM. ASyS Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with ASyS. IMNM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with IMNM. JIIM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with JIIM.
- Experimental: CABA-201 Phase 2b - Sub-study 1Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with DM and ASyS.
- Experimental: CABA-201 Phase 2b - Sub-study 2Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with IMNM.
Primary Outcome Measure
Phase 1/2: Incidence and severity of adverse events (AEs) [ Time Frame: Up to 28 days after CABA-201 infusion ]
Central Contacts
- Cabaletta Bio267-759-3100
Locations (31)
Find similar trials in Orange, CA
By research site
University of California Irvine - Accepting Adult Patients· Orange, CAUniversity of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients· San Francisco, CAChildren's Hospital Colorado - Accepting Juvenile Patients· Aurora, COMayo Clinic Florida - Accepting Adult Patients· Jacksonville, FLJohns Hopkins All Children's Hospital - Accepting Juvenile Patients· St. Petersburg, FLChildren's Healthcare of Atlanta - Accepting Juvenile Patients· Atlanta, GA
Related Studies
- Adult and Juvenile MyositisRecruiting · National Institute of Environmental Health Sciences (NIEHS) · Atlanta, Georgia
- Studies of the Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases Including Juvenile DermatomyositisRecruiting · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Bethesda, Maryland
- Environmental Risk Factors for the Anti-synthetase SyndromeRecruiting · National Institute of Environmental Health Sciences (NIEHS) · Miami, Florida
- Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania