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)
Start Date
9/29/2020
Completion Date
1/1/2029
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
Detailed Description
Pemphigus vulgaris (PV) is a B-cell mediated autoimmune disorder in which painful blisters are formed on the skin or mucosal membrane, including the mouth, nose, throat, eyelids, anus, and genitals. This phase 1/2 study is being conducted in two parts. The first part is the main study 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 mucosal PV who are inadequately managed by standard therapies. This study is closed to enrollment. The second part is a sub-study is being conducted to investigate if CABA-201, also called resecabtagene autoleucel, or "rese-cel", can be safely administered while achieving clinical responses without the need for preconditioning in mucosal-dominant PV (mPV) and mucocutaneous PV (mcPV) patients. This sub-study is open to enrollment. DSG3-CAART or CABA-201 may potentially lead to complete and durable remission of disease.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
DSG3-CAART
CABA-201
Conditions
Locations
Stanford University, Dept. of Dermatology
Redwood City, California 94063
United States
UC Davis, Dept. of Dermatology
Sacramento, California 95816
United States
Yale University
New Haven, Connecticut 06520
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Iowa
Iowa City, Iowa 52242
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Mount Sinai - Icahn School of Medicine
New York, New York 10029
United States
Columbia University
New York, New York 10032
United States
University of North Carolina, Department of Dermatology
Chapel Hill, North Carolina 27516
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
UT Southwestern Medical Center, Dept. of Dermatology
Dallas, Texas 75235
United States
MD Anderson Texas Medical Center
Houston, Texas 77030
United States
University of Washington
Seattle, Washington 98109
United States