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Anti-HER2 CAR-T cell therapy is a form of adoptive cell immunotherapy currently under investigation for the treatment of HER2-positive solid tumors. The therapy involves harvesting a patient's T cells and engineering them to express a chimeric antigen receptor (CAR) specific to the HER2 (ERBB2) protein, which is frequently overexpressed in cancers such as breast, gastric, and ovarian malignancies. These engineered cells typically incorporate intracellular signaling domains, such as CD3-zeta, along with co-stimulatory domains like CD28 or 4-1BB (CD137) to enhance T-cell activation, persistence, and anti-tumor efficacy. Administered via intravenous infusion following lymphodepleting chemotherapy, this modality aims to overcome the immunosuppressive microenvironment of solid tumors. Multiple academic and commercial entities are developing various iterations of this platform, which are currently primarily in Phase 1 clinical trials.
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