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 Clinical Trial for Patients with Pemphigus Vulgaris (PV), Sponsored by Cabaletta Bio, Inc.
Learn more about our Phase 1/2 trial in pemphigus vulgaris 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 Pemphigus Vulgaris
What is pemphigus vulgaris?
Pemphigus vulgaris (PV) is an autoimmune disease that occurs when the immune system produces antibodies that attack a protein called desmoglein (DSG). DSG normally enables skin cells and the cells lining the inside of your mouth, nose, throat, eyelids, etc. to bind tightly together. Disruption by the antibodies directed to DSG causes the painful blisters and erosions characteristic of PV. Although the trigger of PV is unknown, these antibodies are produced by B cells, a type of white blood cell in the immune system.
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-PV trial?
RESET-PVTM trial is a Phase 1/2 clinical trial being conducted to evaluate the effects of the investigational cell treatment CABA-201 in patients with pemphigus vulgaris (PV) who have active disease.
What is CABA-201?
CABA-201 is the investigational treatment used in the RESET-PV trial. This clinical trial evaluates the safety, tolerability and effectiveness of CABA-201 in the treatment of pemphigus vulgaris.
CABA-201 is an investigational chimeric antigen receptor (CAR) T cell therapy designed to treat pemphigus vulgaris 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-PV trial?
You or someone you know may be eligible to participate if you:
- Are 18 to 70 years of age.
- Have a diagnosis of pemphigus vulgaris which is not improving or is getting worse after trying to control it with other treatments.
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-PV trial, you will:
- Play an important role in understanding pemphigus vulgaris.
- 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.
What is DSG3-CAART?
This trial, formerly referred to as the DesCAARTesTM clinical trial, has also included evaluation of an investigational product called Desmoglein 3 Chimeric Autoantibody Receptor T (DSG3-CAART) cells in people with mucosal pemphigus vulgaris. The trial is not currently dosing patients with DSG3-CAART as clinical and translational data are being evaluated.