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A Vaccine (RNA-LP) for the Treatment of Recurrent Pediatric High-Grade Glioma and Recurrent Osteosarcoma, RNA PRIME Trial

Trial Status: active

This phase I/II trial tests the safety, side effects, and best dose of a vaccine, ribonucleic acid-lipid nanoparticle (RNA-LP), and to see how well it works in treating pediatric high-grade glioma (pHGG) and osteosarcoma (OSA) that has come back after a period of improvement (recurrent). The RNA-LP vaccine can stimulate the immune system to fight off tumor cells. There are two types of RNA-LP vaccines used in this trial. The first set of study vaccines contain a messenger ribonucleic acid (mRNA) and is called pp65 RNA-LP, which are given to try to change how the tumor behaves. These first study vaccines are “off the shelf” (readily available) and do not contain any genetic material specific to the tumor. The second set of RNA-LP vaccines includes genetic material from the tumor and is a personalized study vaccine called pp65/tumor mRNA RNA-LP. RNA-LP vaccines may help activate the immune system against the tumor and further help recognize attack the tumor cells in the body and not attack normal cells. Giving RNA-LP may be safe, tolerable, and/or effective in treating patients with recurrent pHGG and recurrent OSA.