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 is this study for? Adult patients with Mucosal-Dominant Pemphigus Vulgaris
What treatments are being studied? Autologous Desmoglein 3 CAR-T Cells
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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 \[CABA-201\]) in subjects with active, pemphigus vulgaris
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• 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
Locations
United States
California
Stanford University, Dept. of Dermatology
RECRUITING
Redwood City
UC Davis, Dept. of Dermatology
RECRUITING
Sacramento
Connecticut
Yale University
RECRUITING
New Haven
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
North Carolina
University of North Carolina, Department of Dermatology
WITHDRAWN
Chapel Hill
New York
Columbia University
RECRUITING
New York
Mount Sinai - Icahn School of Medicine
WITHDRAWN
New York
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
UT Southwestern Medical Center, Dept. of Dermatology
RECRUITING
Dallas
MD Anderson Texas Medical Center
RECRUITING
Houston
Washington
University of Washington
COMPLETED
Seattle
Contact Information
Primary
Cabaletta Bio
clinicaltrials@cabalettabio.com
+1 267 759 3100
Time Frame
Start Date: 2020-09-29
Estimated Completion Date: 2029-01
Participants
Target number of participants: 55
Treatments
Experimental: DSG3-CAART or CABA-201
Cohort A: Fractionated infusions of DSG3-CAART at increasing dose levels (6-9 groups) administered as a single cycle.~Cohort B: Consolidation of infusion of DSG3-CAART to fewer fractionations than in Cohort A using the selected dose from Cohort A (1 group) administered as a single cycle.~Cohort C: Infusion of final selected dose and fractionation of DSG3-CAART from Cohorts A and B (1 group) administered as a single cycle.~OR~CABA-201 Cohort: Single infusion of CABA-201.
Authors
Related Therapeutic Areas
Sponsors
Leads: Cabaletta Bio