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)
Recruiting now · Phase 1/Phase 2
Conditions studied: Pemphigus Vulgaris
In brief
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
Key facts
- Study ID
- NCT04422912
- Run by
- Cabaletta Bio
- People needed
- 40
- Starts
- 2020-09-29
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease
- Rituximab in last 12 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased
- Prednisone > 0.25mg/kg/day
- Other autoimmune disorder requiring immunosuppressive therapies
- Investigational treatment in last 3 months
- Exclusion Criteria for CABA-201 sub-study
- Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer) or malignancy diagnosed within the previous 5 years
- Have received rituximab or other anti-CD20 or anti-CD19 therapies in last 12 months unless anti-DSG3 antibody titers have recently increased or PV symptoms have recently worsened
- Prednisone > 0.25mg/kg/day
- Other autoimmune disorder requiring immunosuppressive therapies
- Treatment with any investigational agent within 4 weeks or 5 half-lives, whichever is longer.
Where it is running
- UT Southwestern Medical Center, Dept. of Dermatology — Dallas, Texas, United States (enrolling)
- MD Anderson Texas Medical Center — Houston, Texas, United States (enrolling)
- Stanford University, Dept. of Dermatology — Redwood City, California, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- UC Davis, Dept. of Dermatology — Sacramento, California, United States (enrolling)
- Columbia University — New York, New York, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- University of Washington — Seattle, Washington, United States
- Mount Sinai - Icahn School of Medicine — New York, New York, United States
- University of North Carolina, Department of Dermatology — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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