Phase 12 Study of Autologous CART Cell Therapies DSG3-CAART and CABA-201 for Active Pemphigus Vulgaris

What this Trial Is About

Researchers are evaluating autologous Chimeric Antigen Receptor T cells CART cells in people with active pemphigus vulgaris PV, a condition causing painful blisters on skin and mucous membranes. This phase 12 open-label study includes two parts the main study focused on DSG3-CAART therapy for mucosal PV patients not well controlled by standard treatments, and a sub-study assessing CABA-201 therapy in mucosal-dominant and mucocutaneous PV patients. The study aims to find safe dosing and to understand if these therapies can control disease activity. The main study now closed to enrollment tested different doses and infusion schedules of DSG3-CAART, sometimes combined with other treatments. The open sub-study involves a single infusion of CABA-201 with varying preconditioning regimens using cyclophosphamide and fludarabine. Treatments are given intravenously, and the sub-study is currently enrolling participants. Participants will be monitored for adverse events up to 3 months for DSG3-CAART and up to 156 weeks for CABA-201. Researchers will measure safety, immune cell levels, antibody changes, disease activity scores, and remission status over up to 36 months. The study includes regular clinical assessments, laboratory tests, and ongoing safety follow-up to evaluate treatment effects and tolerability.

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)