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 Active Systemic Lupus Erythematous, Sponsored by Cabaletta Bio, Inc.
Learn more about our Phase 1/2 study in lupus 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 Lupus Erythematosus & Lupus Nephritis
What is systemic lupus erythematosus?
Systemic lupus erythematosus (SLE), or lupus, is a chronic autoimmune disorder in which the body’s own defense system, the immune system, attacks the body by mistake. In lupus, some cells of the immune system, called B cells, produce autoantibodies that attack healthy tissue, leading to inflammation and damage in multiple organs, including the skin, joints, kidneys, heart and lungs.
Lupus nephritis (LN) is a serious manifestation of SLE that occurs when lupus affects the kidneys. LN can lead to kidney failure and the need for dialysis and/or a kidney transplant if not adequately treated.
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-SLE trial?
RESET-SLE is a phase 1/2 clinical trial being conducted to evaluate the effects of the investigational cell treatment CABA-201 for the treatment of SLE in patients with active LN or active SLE without renal involvement.
What is CABA-201?
CABA-201 is the investigational treatment used in the RESET-SLE study. This clinical trial evaluates the safety, tolerability and effectiveness of CABA-201 in the treatment of lupus.
CABA-201 is an investigational chimeric antigen receptor (CAR) T cell therapy designed to treat lupus 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-SLE trial?
You or someone you know may be eligible to participate if you:
- Are 18 to 65 years of age.
- Have a diagnosis of SLE.
- Have a positive antinuclear antibody (ANA) titer or anti-dsDNA antibody.
- For LN participants only: Have active, biopsy-proven LN class III or IV, with or without the presence of class V.
- Have active disease despite being on medications to treat lupus.
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-SLE study, you will:
- Play an important role in understanding lupus.
- 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.