RecruitingAdult GlioblastomaHigh Grade GliomaWHO Grade III or IV Malignant Glioma
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Eligible age
4+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD
Sponsor: University of Florida
You may not qualify if…
- ✕ Stratum 1 (Adult GBM)
- ✕ Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)
- ✕ MGMT Methylated tumors
- ✕ Gliomatosis Cerebri
- ✕ Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
- ✕ Recurrent or multifocal malignant gliomas.
- ✕ Metastatic or leptomeningeal disease
- ✕ Residual post-surgical disease burden \> 3 cm as defined by longest perpendicular diameter on MRI.
Where it's recruiting
District of Columbia
Washington D.C.
Florida
Gainesville
Source: ClinicalTrials.gov · NCT04573140 · last updated 2026-06-25