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)

PHASE1RecruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

September 29, 2020

Primary Completion Date

January 31, 2029

Study Completion Date

January 31, 2029

Conditions
Pemphigus Vulgaris
Interventions
BIOLOGICAL

DSG3-CAART or CABA-201

"Intravenous infusions of DSG3-CAART alone at different doses and different fractionations. Subjects may also receive varying doses of DSG3-CAART as part of a sub-study, which will employ pre-treatment with intravenous immunoglobulin, cyclophosphamide, and with or without fludarabine to potentially increase the in vivo expansion, persistence and activity of DSG3-CAART.~OR~CABA-201: Single intravenous infusion of CABA-201."

Trial Locations (13)

10029

WITHDRAWN

Mount Sinai - Icahn School of Medicine, New York

10032

RECRUITING

Columbia University, New York

19104

RECRUITING

University of Pennsylvania, Philadelphia

27516

WITHDRAWN

University of North Carolina, Department of Dermatology, Chapel Hill

52242

RECRUITING

University of Iowa, Iowa City

60611

RECRUITING

Northwestern University, Chicago

75235

RECRUITING

UT Southwestern Medical Center, Dept. of Dermatology, Dallas

77030

RECRUITING

MD Anderson Texas Medical Center, Houston

94063

RECRUITING

Stanford University, Dept. of Dermatology, Redwood City

95816

RECRUITING

UC Davis, Dept. of Dermatology, Sacramento

98109

COMPLETED

University of Washington, Seattle

06520

RECRUITING

Yale University, New Haven

02115

RECRUITING

Brigham and Women's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cabaletta Bio

INDUSTRY