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DSG3-CAART Cell Therapy for Pemphigus Vulgaris
Study Summary
This trial is testing a new cell therapy for people with an autoimmune disorder that causes blisters on mucosal membranes. The goal is to find the maximum tolerated dose and best schedule for infusions of the therapy. The therapy has the potential to put the disease into complete remission.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My mPV has not improved with standard immune treatments.You have active myeloproliferative variant at the time of screening.I am on immunosuppressive drugs for an autoimmune disorder.I am taking more than 0.25mg/kg/day of Prednisone.You test positive for anti-DSG3 antibodies.I have been diagnosed with mucous membrane pemphigoid and tested positive for anti-DSG3.I have skin lesions due to pemphigus vulgaris, showing more skin than mouth involvement.I haven't taken Rituximab in the last year unless my symptoms worsened or my antibody levels increased.Your blood test shows that you have very low levels of a certain type of white blood cells called lymphocytes.You have been in a research study and received a new treatment in the past 6 months.
- Group 1: DSG3-CAART
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many facilities are conducting this experiment in the North American region?
"Currently, 10 sites are enrolling patients in their respective cities for this clinical trial. These include Houston, Seattle and Redwood City as well as 7 other locales. It is advised to select the closest clinic to reduce travel demands when participating in the study."
Is the recruitment process for this trial still open?
"According to clinicaltrials.gov, this medical research is presently seeking participants. It was initially posted on September 29th 2020 and amended as recently as October 3rd 2022."
To what extent is the test group for this experiment composed of participants?
"To ensure adequate sample size, Cabaletta Bio requires 39 patients who meet the study's prerequisites to complete their trial. The medical sites they are using include MD Anderson Texas Medical Center in Houston and University of Washington in Seattle."
Is the DSG3-CAART protocol sanctioned by the Food and Drug Administration?
"The safety of the drug DSG3-CAART was assessed to be a 1 due to its Phase 1 nature, which denotes that there is currently limited evidence for both efficacy and safe usage."
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