RecruitingRecurrent Glioblastoma

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

Eligible age

18–80 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: University of Florida

You may qualify if…

✓ 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 chemoradiation completion.
✓ Patient must be at least 90 days from completion of prior radiation
✓ Any adverse events patient has experienced from prior therapy must have resolved to ≤ Gr. 1 according to CTCAE (NCI Common Terminology Criteria for Adverse Events) v5.0 prior to enrollment
✓ Patient must be either weaned off steroids or weaned onto physiologic dosing at the time of enrollment.

You may not qualify if…

✕ Patients who received prior treatment with bevacizumab.
✕ Known active infection (requiring treatment by antiviral or antibiotics) or immunosuppressive disease.
✕ Patients with multifocal recurrent disease characterized by more than one enhancing lesion separated by noncontiguous T2/FLAIR signal abnormality. Patients with recurrence outside of the original tumor site are eligible if there is stability at the original site of disease.
✕ Patients with uncontrolled seizure disorders
✕ Any patients that have received any live vaccines within 30 days prior to enrollment
✕ Tumors with primary localization to the brainstem or spinal cord
✕ Severe, active co-morbidity, defined as follows:
✕ Unstable angina and/or congestive heart failure requiring hospitalization.

Where it's recruiting

Florida

Gainesville

Source: ClinicalTrials.gov · NCT06389591 · last updated 2026-05-15