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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)
Biological/Vaccinepp65 RNA loaded lipid particles or pp65 RNA-LPs administered intravenously
RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)
Biological/Vaccinepersonalized tumor mRNA, pp65 fl LAMP mRNA and DOTAP liposomes or RNA loaded lipid particles, RNA-LPs administered intravenously
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Arm 1: pp65 RNA-LPs (DP1) before biopsyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines
Manufacturing feasibility will be determined based on the percentage of vaccines that are successfully manufactured in the DLT window during the first three vaccines. If two-thirds of vaccines are successfully manufactured with Qa/Qc clearance, the investigators will conclude that RNA-LPs can be successfully manufactured.
Time frame
from the date of surgery until administration of third vaccine, up to 20 weeks2
Incidence of investigational treatment related toxicities
AEs and SAEs must be reported begins at time of first investigational product is received and ends 30 days after last investigational product is given.
Time frame
from first vaccine to 30 days after last dose of vaccine administered, up to 17 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov