A Phase I Study of RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)
University of Florida
Summary
This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma.
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. Patients will may receive up to three pp65 RNA-LP vaccines (DP1) before receiving full dose monthly RNA-LPs (RNA loaded lipid particles, RNA-LPs, DP2). All participants will receive the same nu…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>/= 18years * Histopathologically proven GBM using the 2021 WHO Classification of Tumors of the CNS (WHO CNS5). * Unequivocal evidence of tumor progression as documented by brain MRI scan per RANO criteria. * Tumor must have a primary supratentorial component at the time of disease progression. * Patients must have received surgery and completed Fractionated Radiation therapy as frontline treatment for primary disease, either alone or with concurrent therapy (including temozolomide or another systemic chemotherapy agent). Patients must be at least 12 weeks post chem…
Interventions
- Biologicalpp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)
pp65 RNA loaded lipid particles or pp65 RNA-LPs administered intravenously
- BiologicalRNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)
personalized tumor mRNA, pp65 fl LAMP mRNA and DOTAP liposomes or RNA loaded lipid particles, RNA-LPs administered intravenously
Location
- UF HealthGainesville, Florida