Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Mehrdad Abedi, MD

Description

Summary

Mucosal-dominant pemphigus vulgaris (mPV) is a B-cell mediated autoimmune disorder in which painful blisters are formed on the mucosal membrane, including the mouth, nose, throat, eyelids, anus, and genitals. This phase 1 study is being conducted to find the maximum tolerated dose and optimal fractionated infusion schedule of an investigational cell therapy, DSG3-CAART, that can be given to patients with mPV who are inadequately managed by standard therapies. DSG3-CAART may potentially lead to complete and durable remission of disease.

Official Title

A Phase 1, Open-label, Safety and Dosing Study of Autologous Desmoglein 3 Chimeric Autoantibody Receptor T Cells (DSG3-CAART) in Subjects With Active, Anti-DSG3, Mucosal-dominant Pemphigus Vulgaris

Keywords

Mucosal -Dominant Pemphigus Vulgaris Pemphigus Pemphigus Vulgaris CAAR-T Therapy CAR-T Therapy Desmoglein 3 Cell Therapy Autoimmune Disease Autoimmunity Skin Diseases, Vesiculobullous Immunotherapy, Adoptive Immune System Diseases DSG3-CAART

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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 6 months
  • Absolute lymphocyte count < 1,000/µL at screening

Locations

  • UC Davis, Dept. of Dermatology accepting new patients
    Sacramento California 95816 United States
  • Stanford University, Dept. of Dermatology accepting new patients
    Redwood City California 94063 United States

Lead Scientist at UC Davis

  • Mehrdad Abedi, MD
    Professor, Hematology and Oncology. Authored (or co-authored) 61 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cabaletta Bio
Links
Sign up for this study
ID
NCT04422912
Phase
Phase 1
Study Type
Interventional
Last Updated