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CAR T-cell Therapy

DSG3-CAART Cell Therapy for Pemphigus Vulgaris

Phase 1
Recruiting
Research Sponsored by Cabaletta Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
mPV inadequately managed by at least one standard immunosuppressive therapies
Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

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.

Who is the study for?
This trial is for patients with mucosal-dominant pemphigus vulgaris (mPV) who haven't responded well to standard treatments. They must have active mPV symptoms, a positive anti-DSG3 antibody test, and a confirmed diagnosis. People can't join if they've had certain other treatments recently or have another autoimmune disease needing treatment.Check my eligibility
What is being tested?
The study is testing DSG3-CAART, an experimental cell therapy aimed at achieving long-lasting remission in mPV patients. The goal is to find the highest dose that's safe and work out the best schedule for giving it to patients.See study design
What are the potential side effects?
Since this is a phase 1 trial determining the maximum tolerated dose of DSG3-CAART, specific side effects are not listed but may include reactions related to immune system activation or suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My mPV has not improved with standard immune treatments.
Select...
I have been diagnosed with mucous membrane pemphigoid and tested positive for anti-DSG3.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events, including Dose Limit Toxicity
Secondary outcome measures
Cellular kinetics profile of DSG3-CAART
Change in DSG3 autoantibody titer
Clinical remission: complete remission off therapy and complete remission on minimal therapy
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DSG3-CAARTExperimental Treatment1 Intervention
Cohort A: Fractionated infusions of DSG3-CAART at increasing dose levels (6-9 groups) administered as a single cycle. Cohort B: Consolidation of infusion of DSG3-CAART to fewer fractionations than in Cohort A using the selected dose from Cohort A (1 group) administered as a single cycle. Cohort C: Infusion of final selected dose and fractionation of DSG3-CAART from Cohorts A and B (1 group) administered as a single cycle

Find a Location

Who is running the clinical trial?

Cabaletta BioLead Sponsor
4 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

DSG3-CAART (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04422912 — Phase 1
Pemphigus Vulgaris Research Study Groups: DSG3-CAART
Pemphigus Vulgaris Clinical Trial 2023: DSG3-CAART Highlights & Side Effects. Trial Name: NCT04422912 — Phase 1
DSG3-CAART (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04422912 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~16 spots leftby Sep 2026