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NCT06389591 · ClinicalTrials.gov registry record · Phase 1
RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)
A Phase 1 study of Recurrent Glioblastoma, sponsored by University of Florida.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06389591: Active Phase 1 study of Recurrent Glioblastoma, sponsored by University of Florida.
NCT06389591 is a Phase 1 study of Recurrent Glioblastoma that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 24 participants, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06389591, a Phase 1 study of Recurrent Glioblastoma, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)
- BIOLOGICAL RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)
Study Locations (1)
Florida
- UF Health - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-12-02 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What the registry record for NCT06389591 still lists
NCT06389591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1) is the first listed.
NCT06389591 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06389591 about?
NCT06389591 is a clinical study titled "RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)". 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.
What is the current status of trial NCT06389591?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-12-02. Estimated completion is 2027-12-01.
What conditions does trial NCT06389591 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma.
What interventions are being tested in trial NCT06389591?
The interventions under investigation include: pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1) (BIOLOGICAL), RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06389591?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06389591 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06389591's enrollment target sits among peer trials
24 41st of 62 higher than 21 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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