Trials / Recruiting
RecruitingNCT06154252
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
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- Sponsor
- Cabaletta Bio · Industry
- Sex
- All
- Age
- 6 Years – 75 Years
- Healthy volunteers
- Not accepted
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 subtypes of IIM, including dermatomyositis (DM), anti-synthetase syndrome (ASyS), immune-mediated necrotizing myopathy (IMNM), and juvenile idiopathic inflammatory myopathy (JIIM), are thought to involve B cells that cause the body to attack different tissues in the body. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with DM, ASyS, IMNM, or JIIM who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.
Conditions
- Idiopathic Inflammatory Myopathy
- Dermatomyositis
- Anti-Synthetase Syndrome
- Immune-Mediated Necrotizing Myopathy
- Juvenile Dermatomyositis
- Juvenile Polymyositis
- Juvenile Idiopathic Inflammatory Myopathy (JIIM)
- Juvenile Myositis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CABA-201 following preconditioning with fludarabine and cyclophosphamide | Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2028-07-01
- Completion
- 2028-07-01
- First posted
- 2023-12-04
- Last updated
- 2026-04-16
Locations
33 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06154252. Inclusion in this directory is not an endorsement.