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 Systemic Sclerosis, Sponsored by Cabaletta Bio, Inc.
Learn more about our Phase 1/2 study in systemic sclerosis 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 Systemic Sclerosis
What is systemic sclerosis?
Systemic sclerosis (SSc) is a rare autoimmune disease that can affect the skin and organs in the body such as the heart, lungs and kidneys. The cause of SSc is unknown, but it is thought to involve the immune system attacking tissues throughout the body. The immune system is made up of different types of white blood cells, including B cells. Abnormal B cells are thought to cause inflammation and damage seen in SSc.
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-SSc trial?
RESET-SSc is a phase 1/2 clinical trial being conducted to evaluate the effects of the investigational cell treatment CABA-201 for the treatment of systemic sclerosis (SSc).
What is CABA-201?
CABA-201 is the investigational treatment used in the RESET-SSc study. This clinical trial evaluates the safety, tolerability and effectiveness of CABA-201 in the treatment of systemic sclerosis.
CABA-201 is an investigational chimeric antigen receptor (CAR) T cell therapy designed to treat systemic sclerosis 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-SSc trial?
You or someone you know may be eligible to participate if you:
- Are 18 to 70 years of age.
- Have a diagnosis of limited or diffuse systemic sclerosis.
- Have active disease despite being on medications to treat systemic sclerosis.
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-SSc study, you will:
- Play an important role in understanding systemic sclerosis.
- 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.