Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04422912 | 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) | PHASE1 | RECRUITING | 40 | — | — | Sep 29, 2020 | Jan 1, 2029 | May 29, 2026 | 13 | United States |
Incidence of adverse events that are related to DSG3-CAART therapy
Incidence and severity of AEs
| Arm | Type | Description |
|---|---|---|
| DSG3-CAART | EXPERIMENTAL | Single or multiple intravenous infusion(s) of DSG3-CAART at varying dose levels. This study is now closed to enrollment. |
| CABA-201 | EXPERIMENTAL | Infusion of CABA-201 with or without cyclophosphamide and fludarabine preconditioning, or with or without cyclophosphamide preconditioning. This sub-study is open to enrollment. |
| Name | Type | Description |
|---|---|---|
| DSG3-CAART | BIOLOGICAL | Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine. |
| CABA-201 | BIOLOGICAL | Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning. |
Inclusion Criteria for DSG3-CAART: Closed to enrollment * 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 positiv...