Open-label Study to Determine the Maximum Tolerated Dose of DSG3-CAART in Mucosal-dominant PV Patients (mPV)
Mucosal -Dominant Pemphigus Vulgaris
About this trial
This is an interventional treatment trial for Mucosal -Dominant Pemphigus Vulgaris focused on measuring Pemphigus, Pemphigus Vulgaris, CAAR-T Therapy, CAR-T Therapy, Desmoglein 3, Cell Therapy, Autoimmune Disease, Autoimmunity, Skin Diseases, Vesiculobullous, Immunotherapy, Adoptive, Immune System Diseases
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA
- mPV inadequately managed by at least one standard immunosuppressive therapies
- Active mPV at screening
- Anti-DSG3 antibody ELISA positive at screening
Exclusion Criteria:
- Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease
- Rituximab in last 12 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased
- Prednisone > 0.25mg/kg/day
- Other autoimmune disorder requiring immunosuppressive therapies
- Investigational treatment in last 6 months
- Absolute lymphocyte count < 1,000/µL at screening
Sites / Locations
- Stanford University, Dept. of DermatologyRecruiting
- UC Davis, Dept. of DermatologyRecruiting
- Northwestern UniversityRecruiting
- University of IowaRecruiting
- Mount Sinai - Icahn School of MedicineRecruiting
- University of North Carolina, Department of DermatologyRecruiting
- University of PennsylvaniaRecruiting
- UT Southwestern Medical Center, Dept. of DermatologyRecruiting
- MD Anderson Texas Medical CenterRecruiting
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Experimental
DSG3-CAART
Cohort A: Fractionated infusions of DSG3-CAART at increasing dose levels (6-9 groups) administered as a single cycle. Cohort B: Consolidation of infusion of DSG3-CAART to fewer fractionations than in Cohort A using the selected dose from Cohort A (1 group) administered as a single cycle. Cohort C: Infusion of final selected dose and fractionation of DSG3-CAART from Cohorts A and B (1 group) administered as a single cycle