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

Sponsors and collaborators