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This is an investigational autologous CAR T-cell therapy developed by Fuda Cancer Hospital in Guangzhou, China, for the treatment of advanced or recurrent HER2-positive breast cancer. The therapy involves the genetic modification of a patient's own T cells using a retroviral vector to express a chimeric antigen receptor (CAR) specific to the Human Epidermal Growth Factor Receptor 2 (HER2). The CAR construct includes a HER2-targeting single-chain variable fragment (scFv) coupled with CD28 and CD3 zeta intracellular signaling domains to provide both activation and co-stimulatory signals upon antigen binding. This cell-based immunotherapy is designed to selectively target and eliminate HER2-overexpressing malignant cells and is currently being evaluated in a Phase 1/2 clinical trial (NCT02547961) to assess safety, persistence, and therapeutic efficacy.
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