RecruitingPhase 1Phase 2NCT04422912

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)

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

Sponsor

Cabaletta Bio

Enrollment

40 participants

Start Date

Sep 29, 2020

Study Type

INTERVENTIONAL

Conditions

Pemphigus Vulgaris

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CABA-201 and a biological treatment called DSG3-CAART for people with pemphigus vulgaris. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDSG3-CAART

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

BIOLOGICALCABA-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

View Full Details on ClinicalTrials.gov

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NCT04422912

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