Status:
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)
Lead Sponsor:
Cabaletta Bio
Conditions:
Pemphigus Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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-...
Detailed Description
Pemphigus vulgaris (PV) is a B-cell mediated autoimmune disorder in which painful blisters are formed on the skin or mucosal membrane, including the mouth, nose, throat, eyelids, anus, and genitals. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for DSG3-CAART: Closed to enrollment
- Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA
- mPV inadequately managed by at least one standard immunosuppressive therapies
- Active mPV at screening
- Anti-DSG3 antibody ELISA positive at screening
- Inclusion Criteria for CABA-201 sub-study: Open to enrollment
- Age ≥18
- Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and/or DIF
- PV inadequately managed by at least one standard immunosuppressive therapy
- Active PV at screening
- DSG3 ELISA positive at screening
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04422912
Start Date
September 29 2020
End Date
January 1 2029
Last Update
December 17 2025
Active Locations (13)
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1
Stanford University, Dept. of Dermatology
Redwood City, California, United States, 94063
2
UC Davis, Dept. of Dermatology
Sacramento, California, United States, 95816
3
Yale University
New Haven, Connecticut, United States, 06520
4
Northwestern University
Chicago, Illinois, United States, 60611