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A patient-specific cancer vaccine created by harvesting and culturing autologous tumor cells, transducing them ex vivo with the human B7-1 (CD80) gene to enforce co-stimulatory molecule expression, irradiating, and then administering them subcutaneously to stimulate anti-tumor T-cell responses; often evaluated in combination with systemic interleukin-2 to expand vaccine-activated T cells. In a renal cell carcinoma Phase I study, the approach was feasible and well tolerated with no significant vaccine-related toxicity, and showed partial responses and stable disease in some patients; Phase II evaluation in stage IV renal cell carcinoma was subsequently conducted. Mechanistically, enforced B7-1 expression provides CD28-mediated co-stimulation to T cells encountering tumor antigens, converting tolerizing interactions into activating signals to elicit cytotoxic anti-tumor immunity. Developers included academic investigators conducting gene-modified autologous tumor cell vaccine trials in metastatic renal cell carcinoma. [1][6][9]
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