Actively Recruiting
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Led by Cabaletta Bio · Updated on 2025-12-17
40
Participants Needed
13
Research Sites
430 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 1/2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells \[DSG3-CAART\] or CD19-specific Chimeric Antigen Receptor T cells \[CABA-201\]) in subjects with active, pemphigus vulgaris
CONDITIONS
Official Title
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of mucosal pemphigus vulgaris (mPV) by biopsy and positive anti-DSG3 antibody test (for DSG3-CAART; closed to enrollment)
- mPV inadequately managed by at least one standard immunosuppressive therapy (for DSG3-CAART; closed to enrollment)
- Active mucosal pemphigus vulgaris at screening (for DSG3-CAART; closed to enrollment)
- Positive anti-DSG3 antibody test at screening (for DSG3-CAART; closed to enrollment)
- Age 18 years or older (for CABA-201 sub-study; open to enrollment)
- Confirmed diagnosis of pemphigus vulgaris by biopsy and positive DSG3 ELISA, IIF, or DIF test (for CABA-201 sub-study; open to enrollment)
- Pemphigus vulgaris inadequately managed by at least one standard immunosuppressive therapy (for CABA-201 sub-study; open to enrollment)
- Active pemphigus vulgaris at screening (for CABA-201 sub-study; open to enrollment)
- Positive DSG3 ELISA test at screening (for CABA-201 sub-study; open to enrollment)
You will not qualify if you...
- Active cutaneous lesions indicating mucocutaneous rather than mucosal-dominant pemphigus vulgaris
- Received rituximab in the last 12 months unless symptoms have worsened or antibody levels have increased recently
- Taking prednisone at a dose higher than 0.25 mg/kg/day
- Having another autoimmune disorder requiring immunosuppressive therapy
- Received any investigational treatment within the last 3 months
- For CABA-201 sub-study: having paraneoplastic pemphigus or active cancer (except non-melanoma skin cancer) or cancer diagnosed within the last 5 years
- For CABA-201 sub-study: received rituximab or other anti-CD20 or anti-CD19 therapies within 12 months unless symptoms or antibody levels have worsened
- For CABA-201 sub-study: treatment with any investigational agent within 4 weeks or 5 half-lives, whichever is longer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Stanford University, Dept. of Dermatology
Redwood City, California, United States, 94063
Actively Recruiting
2
UC Davis, Dept. of Dermatology
Sacramento, California, United States, 95816
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Mount Sinai - Icahn School of Medicine
New York, New York, United States, 10029
Withdrawn
8
Columbia University
New York, New York, United States, 10032
Actively Recruiting
9
University of North Carolina, Department of Dermatology
Chapel Hill, North Carolina, United States, 27516
Withdrawn
10
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
UT Southwestern Medical Center, Dept. of Dermatology
Dallas, Texas, United States, 75235
Actively Recruiting
12
MD Anderson Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Washington
Seattle, Washington, United States, 98109
Completed
Research Team
C
Cabaletta Bio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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