RNA-lipid nanoparticle vaccine for newly diagnosed glioblastoma
A phase I study of RNA-lipid particle vaccines for newly-diagnosed glioblastoma, IND19304 08/21/2020
A new RNA-based lipid nanoparticle vaccine aims to help people newly diagnosed with glioblastoma by training their immune system to recognize and attack the tumor.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Florida NIH-funded |
| Lab location | 1 site (Gainesville, United States) |
| Project ID | NIH-11162296 on NIH RePORTER |
What this research studies
If I join, doctors will give me an experimental vaccine made from tumor RNA packaged in multi-layer lipid nanoparticles designed to mimic a viral infection and jump-start immune responses. The treatment is given systemically and is intended to activate dendritic cells and T cells that can target glioma cells inside the brain. Researchers have seen strong anti-tumor effects in mouse models and encouraging safety and survival signals in a large-animal (pet dog) trial, and the therapy now has FDA IND clearance to begin human testing. This is an early-phase (Phase I) clinical effort focused on people with newly diagnosed glioblastoma to learn about safety, immune effects, and initial signs of benefit.
Who could benefit from this research
Good fit: People newly diagnosed with glioblastoma who are medically stable after initial surgery and able to receive an experimental immunotherapy are the likely candidates.
Not a fit: Patients without glioblastoma, those with recurrent disease who no longer meet the trial criteria, or people with certain uncontrolled autoimmune conditions may not be eligible or likely to benefit.
Why it matters
Potential benefit: If successful, the vaccine could help the immune system attack glioblastoma cells and potentially slow tumor growth or improve survival.
How similar studies have performed: Preclinical mouse studies showed robust anti-tumor activity and a canine glioma trial showed the vaccine was feasible, safe, immunologically active, and associated with improved overall survival compared with historical controls, but human data are still novel.
Where this research is happening
Gainesville, United States
- University of Florida — Gainesville, United States (Active)
Researchers
- Principal investigator: Sayour, Elias — University of Florida
- Study coordinator: Sayour, Elias
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.