Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.
Are You an Eligible Patient?
A Phase 1/2 Open-Label Study of Autologous CD19-Specific Chimeric Antigen Receptor T Cells (CABA-201) in Idiopathic Inflammatory Myopathy, Sponsored by Cabaletta Bio, Inc.
Learn more about our Phase 1/2 study in myositis through our clinical trial page at ClinicalTrials.gov.
Contact Us
Are you wondering if this clinical trial is right for you? To find out more, contact the study team using the information below.
Learn About Idiopathic Inflammatory Myopathy (IIM), or Myositis
What is myositis?
Myositis is a group of autoimmune diseases characterized by inflammation and muscle weakness. Myositis results when your body’s own defense system, the immune system, attacks the muscles in your body by mistake. In some cases, myositis may also affect other organs in the body, such as the lungs, heart or skin. There are several subtypes of myositis, including dermatomyositis, antisynthetase syndrome and immune-mediated necrotizing myopathy.
Learn About Our Trial
What is a clinical trial?
A clinical trial is designed to evaluate whether an investigational treatment is safe and effective for use in humans.
What is Cabaletta’s RESET-Myositis Trial?
RESET-Myositis is a phase 1/2 clinical trial being conducted to evaluate the effects of the investigational cell treatment CABA-201 in patients with dermatomyositis (DM), antisynthetase syndrome (ASyS) and immune-mediated necrotizing myopathy (IMNM) who have active disease.
What is CABA-201?
CABA-201 is the investigational treatment used in the RESET-Myositis study. This clinical trial evaluates the safety, tolerability and effectiveness of CABA-201 in the treatment of myositis.
CABA-201 is an investigational chimeric antigen receptor (CAR) T cell therapy designed to treat myositis by targeting the B cells that may be causing the disease.
CABA-201 is made from your own T cells, a type of white blood cell, and uses your own immune system to get rid of the disease-causing B cells and to restore healthy B cells in your body.
Who can participate in Cabaletta’s RESET-Myositis trial?
You or someone you know may be eligible to participate if you:
- Are 18 to 75 years of age (adult cohorts).
- Are 6 to 17 years of age (juvenile cohort).
- Have a diagnosis of myositis.
- Have at least one autoantibody associated with one of the myositis subtypes: dermatomyositis, antisynthetase syndrome or immune-mediated necrotizing myopathy.
- Have active disease despite being on medications to treat myositis.
Additional requirements will apply, and only a study doctor can determine eligibility to participate in the study. Sites involved in the study are listed at ClinicalTrials.gov.
Why participate in this study?
By participating in the RESET-Myositis study, you will:
- Play an important role in understanding myositis.
- Receive study-related care, tests and procedures from a study doctor at no cost to you.
- Receive compensation for your time during certain study visits and reimbursement for reasonable travel expenses.
What are the potential risks of participating in this trial?
Therapy with CAR T cells may cause serious and potentially life-threatening side effects. The potential risks of participating in this clinical trial will be explained to you before you decide whether to participate.