RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)

Description

This is a first in human Phase I study of RNA-LP vaccines for recurrent adult glioblastoma. Participants will receive two study drug products. The first, pp65 RNA-LP, is a messenger RNA (mRNA) pp65 vaccine given for the first 3 vaccines to try to change how the tumor behaves. The second study drug RNA-LP, given as monthly vaccines 4-15, includes pp65 mRNA and tumor RNA from each patient’s tumor tissue.

There will be two groups in this study, one that will start pp65 RNA-LP prior to surgery and the other will start RNA-LP following the procedure. All participants will receive the same number of vaccines, up to 15. Study group assignment is done randomly (by chance) and is similar to the tossing of a coin. Neither the participant nor your study doctor can decide group assignment.

The immunotherapy with RNA lipid particle (RNA-LP) vaccines is the treatment portion of this study. During this study, we will make, test and give the RNA-LP vaccine therapy. As part of this study, participants will undergo up to 4 additional MRIs.