RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)
ConditionRecurrent Glioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)
- RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Florida
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov