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 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.
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)
Enter a location and click search to find clinical trials sorted by distance.
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