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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, an autoimmune blistering skin condition. It is designed to target and eliminate the specific immune cells that produce antibodies against desmoglein 3, a protein involved in skin cell adhesion, potentially reducing disease activity.
DSG3-CAART targets DSG3, which is desmoglein 3, a protein found on the surface of skin cells. The therapy is engineered to recognize and attack the B cells that produce autoantibodies against DSG3, which are responsible for the blistering seen in Pemphigus Vulgaris.
DSG3-CAART is being developed by Cabaletta Bio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CABA. The company is focused on developing targeted cellular therapies for autoimmune diseases.
DSG3-CAART is currently in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The drug has received Orphan Drug and Fast Track designations from the FDA, which are intended to expedite its development and review.
DSG3-CAART is being evaluated in a Phase 1/2 clinical trial with the identifier NCT04422912, known as the RESET-PV study. This open-label, controlled trial is recruiting approximately 40 participants with active Pemphigus Vulgaris in the United States. The study is not randomized or double-blinded.
DSG3-CAART is not the same as CABA-201. The RESET-PV trial is studying two separate investigational cell therapies: DSG3-CAART, which targets desmoglein 3, and CABA-201, which targets CD19. Both are being tested in patients with Pemphigus Vulgaris, but they have different molecular targets.