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.

Page 1 of 4 (13 locations)

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

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) | DecenTrialz