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DSG3-CAART · 1 trial · 1 indication
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| 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...
DSG3-CAART is an investigational cell therapy being studied for the treatment of Pemphigus Vulgaris, a rare autoimmune blistering skin disease. It is designed to target and eliminate the specific immune cells that produce antibodies against desmoglein 3, a protein essential for skin cell adhesion. The drug is currently in Phase 1 clinical development.
DSG3-CAART targets desmoglein 3, a protein involved in cell-to-cell adhesion in the skin. The therapy is engineered to recognize and destroy the autoreactive B cells that produce antibodies against desmoglein 3, which are responsible for the blistering seen in Pemphigus Vulgaris. This targeted approach aims to halt the autoimmune attack while preserving normal immune function.
DSG3-CAART is being developed by Cabaletta Bio, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CABA. The company specializes in developing engineered T cell therapies for autoimmune diseases. Cabaletta Bio is conducting the clinical trials for DSG3-CAART in patients with Pemphigus Vulgaris.
DSG3-CAART is currently in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials. The drug has received Orphan Drug and Fast Track designations from the FDA, which may expedite its development and review process.
DSG3-CAART is being studied in a single clinical trial with the identifier NCT04422912, known as the RESET-PV study. This is a Phase 1/2, open-label, controlled trial enrolling approximately 40 participants with active Pemphigus Vulgaris in the United States. The study is currently recruiting patients aged 18 years and older.
DSG3-CAART and CABA-201 are distinct investigational therapies, though they are both being studied in the same clinical trial for Pemphigus Vulgaris. DSG3-CAART is a chimeric autoantibody receptor T cell therapy targeting desmoglein 3, while CABA-201 is a CD19-specific chimeric antigen receptor T cell therapy. Both are being evaluated in the RESET-PV study.