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)
Condition(s) studied
Investigational drug(s) / intervention(s)
DSG3-CAART: Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine.
CABA-201: Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.
Study 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
Primary outcome measure(s)
- Adverse events, including Dose Limit Toxicity — 3 months
Incidence of adverse events that are related to DSG3-CAART therapy - For CABA-201 Sub-study: To evaluate adverse events reported by subjects — Up to 28 days after CABA-201 infusion
Incidence and severity of AEs
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Stanford University, Dept. of Dermatology | Redwood City | California | Recruiting |
| UC Davis, Dept. of Dermatology | Sacramento | California | Recruiting |
| Yale University | New Haven | Connecticut | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Mount Sinai - Icahn School of Medicine | New York | New York | Withdrawn |
| Columbia University | New York | New York | Recruiting |
| University of North Carolina, Department of Dermatology | Chapel Hill | North Carolina | Withdrawn |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| UT Southwestern Medical Center, Dept. of Dermatology | Dallas | Texas | Recruiting |
| MD Anderson Texas Medical Center | Houston | Texas | Recruiting |
| University of Washington | Seattle | Washington | Completed |
More Cabaletta Bio trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04422912 on ClinicalTrials.gov ↗ ← All trials in the USA