Definition

A preparation of autologous, interleukin-15 (IL-15)-expanded, human epidermal growth factor receptor 2 (EGFR2; HER2; ErbB2)-specific, cluster of differentiation 4 (CD4)-positive T lymphocytes, with potential immunostimulating and antineoplastic activities. Autologous HER2-specific CD4+ T cells are expanded ex vivo with IL-15. Upon reintroduction into the patient, the autologous IL-15-expanded HER2-specific CD4+ T-cells recognize and stimulate a T-cell-mediated immune response against HER2-expressing tumor cells. HER2, a receptor tyrosine kinase (RTK) mutated or overexpressed in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization. IL-15 is a cytokine that enhances T-cell expansion.