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)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCabaletta Bio

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • DSG3-CAART
  • CABA-201

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

13
California
Stanford University, Dept. of Dermatology94063, Redwood City United States
UC Davis, Dept. of Dermatology95816, Sacramento United States
Connecticut
Yale University06520, New Haven United States
Illinois
Northwestern University60611, Chicago United States

Sponsors and collaborators

Cabaletta Bio

Lead sponsor