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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)

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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

What is being tested

Sponsor: Cabaletta Bio · Participants: 40 · Started: Sep 29, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04422912

Locations in the U.S.

CaliforniaStanford University, Dept. of Dermatology, Redwood City
UC Davis, Dept. of Dermatology, Sacramento
ConnecticutYale University, New Haven
IllinoisNorthwestern University, Chicago
IowaUniversity of Iowa, Iowa City
MassachusettsBrigham and Women's Hospital, Boston
New YorkColumbia University, New York
PennsylvaniaUniversity of Pennsylvania, Philadelphia
TexasUT Southwestern Medical Center, Dept. of Dermatology, Dallas
MD Anderson Texas Medical Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.