RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Glioblastoma
This study is testing RNA-Lipid Particle (RNA-LP) vaccines for adults with recurrent glioblastoma (a type of brain cancer). The goal is to see if these vaccines can be safely made and given, and to find the highest safe dose. You would receive two types of vaccines: first, pp65 RNA loaded lipid particles (DP1), and then personalized RNA loaded lipid particles (DP2) which include RNA from your own tumor. This treatment works by using your body's immune system (immunotherapy) to fight the cancer. To join, you must be between 18 and 80 years old, have glioblastoma that has returned, and show clear signs of tumor growth on an MRI. The study is currently unclear about its recruitment status and plans to enroll 24 participants.
- Study design
- This is a Phase 1 study, meaning it's the first time these vaccines are being tested in humans. It will enroll 24 participants to evaluate safety and manufacturing feasibility.
- What's involved
- You would receive up to 15 vaccines intravenously. You would also undergo up to 4 additional MRI scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the first vaccine until 30 days after the last dose, for up to 17 months.
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NCT06389591
RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)
Recruiting
PHASE1Ages 18–80InterventionalTreatmentUniversity of FloridaInvestigator-initiated
~24 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines
Measured over from the date of surgery until administration of third vaccine, up to 20 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Ashley Ghiaseddin, MD · PRINCIPAL_INVESTIGATOR · University of Florida
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Patient must be a candidate for surgery/biopsy as acceptable standard of care for sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).
A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment.
Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Bone Marrow:
ANC (Absolute neutrophil count) ≥ 1,500µl (unsupported)
Platelets ≥ 100/µl (unsupported for at least 3 days)
Hemoglobin \> 8 g/dL
Renal:
BUN ≤ 25 mg/dl
Creatinine ≤ 1.7 mg/dl
Hepatic
Bilirubin ≤ 2.0 mg/dl
ALT ≤ 5 times institutional upper limits of normal for age
AST ≤ 5 times institutional upper limits of normal for age
Patient must be able to give consent.
For women of childbearing potential (WOCBP), negative serum/urine pregnancy test at enrollment.
WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
Males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.
Exclusion
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.
Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.
Acute bacterial or fungal infection requiring intravenous treatment at study treatment.
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at study treatment
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Patients with autoimmune disease requiring medical management with immunosuppressants.
Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Women of childbearing potential must not be pregnant or breast-feeding.
Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to projected first dose of study treatment.
Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations
What this trial measures
- Percentage of vaccines meeting release criteria in the DLT window during the first three vaccinesfrom the date of surgery until administration of third vaccine, up to 20 weeks
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.
- Incidence of investigational treatment related toxicitiesfrom first vaccine to 30 days after last dose of vaccine administered, up to 17 months
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.