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NCT04573140 · ClinicalTrials.gov registry record · Phase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
A Phase 1 study of High Grade Glioma and Adult Glioblastoma, sponsored by University of Florida.
- Active
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04573140 is a Phase 1 study of High Grade Glioma and Adult Glioblastoma that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 28 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04573140, a Phase 1 study of High Grade Glioma and Adult Glioblastoma, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD
Conditions Studied
Interventions
- BIOLOGICAL Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)
Study Locations (1)
Florida
- UF Health - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04573140
The ClinicalTrials.gov registry entry for NCT04573140 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (57% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs) is the first listed.
NCT04573140 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04573140 about?
NCT04573140 is a clinical study titled "A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)". The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients wit...
What is the current status of trial NCT04573140?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-12-13. Estimated completion is 2029-07-01.
What conditions does trial NCT04573140 study?
This clinical trial studies the following conditions: High Grade Glioma, Adult Glioblastoma, WHO Grade III or IV Malignant Glioma.
What interventions are being tested in trial NCT04573140?
The interventions under investigation include: Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04573140?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04573140 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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