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This is an investigational personalized RNA-lipid particle (RNA-LP) vaccine system developed by the University of Florida for the treatment of recurrent high-grade glioma and recurrent or unresectable osteosarcoma in pediatric and young adult patients. The vaccine regimen consists of two components: DP1, an off-the-shelf vaccine containing mRNA encoding the cytomegalovirus (CMV) phosphoprotein 65 (pp65) antigen used to prime the immune response, and DP2, a patient-specific vaccine containing both pp65 mRNA and personalized tumor-derived mRNA. These mRNAs are encapsulated in DOTAP-based cationic lipid particles. Administered intravenously, the RNA-LPs are designed to localize to lymphoid tissues, transfect and activate antigen-presenting cells (APCs), and induce potent antigen-specific T-cell immunity to overcome the immunosuppressive environment of high-grade brain and bone tumors.
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