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RECRUITING
NCT04422912
PHASE1/PHASE2

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)

Sponsor: Cabaletta Bio

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-09-29

Completion Date

2029-01

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

DSG3-CAART

Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine.

BIOLOGICAL

CABA-201

Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.

Locations (13)

Stanford University, Dept. of Dermatology

Redwood City, California, United States

UC Davis, Dept. of Dermatology

Sacramento, California, United States

Yale University

New Haven, Connecticut, United States

Northwestern University

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mount Sinai - Icahn School of Medicine

New York, New York, United States

Columbia University

New York, New York, United States

University of North Carolina, Department of Dermatology

Chapel Hill, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center, Dept. of Dermatology

Dallas, Texas, United States

MD Anderson Texas Medical Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States