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NCT05660408 · ClinicalTrials.gov registry record · Phase 1
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
A Phase 1 study of Recurrent High Grade Glioma and Recurrent Pulmonary Osteosarcoma, sponsored by University of Florida.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05660408: Active Phase 1 study of Recurrent High Grade Glioma and Recurrent Pulmonary Osteosarcoma, sponsored by University of Florida.
NCT05660408 is a Phase 1 study of Recurrent High Grade Glioma and Recurrent Pulmonary Osteosarcoma that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 36 participants, above the 28-participant average among 4 other Recurrent High Grade Glioma trials with a reported enrollment target (29% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05660408, a Phase 1 study of Recurrent High Grade Glioma and Recurrent Pulmonary Osteosarcoma, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The Investigators have demonstrated in preclinical studies that RNA liposomes activate APCs, induce antigen-specific T cell immunity, and can supplant DCs in a cell therapy model for HGG and have shown feasibility and activity of this approach in preclinical models and in canine patients with a spontaneous malignant glioma. In one arm of this study, we will investigate the safety and immunologic activity of RNA-LP vaccines in pediatric patients with recurrent pHGG. The investigators have also shown that intravenous administration of tumor mRNA loaded lipid particles (LPs) localizes primarily to lung, transfect antigen presenting cells (APCs) and lead to an activated T cell response for induction of anti-tumor immunity. In contrast to other formulations, RNA-LPs recruit multiple arms of the immune system (i.e. innate/adaptive), and remodel the systemic/intratumoral immune milieu, which remain potent barriers for vaccine, cellular, and checkpoint inhibiting immunotherapies. After only a single RNA-LP vaccine, the bulk of systemic and intratumoral dendritic cells (DCs) in mice display an activated phenotype; these activated DCs (harvested from tumors) expand antigen specific T cell immunity. In immunologically resistant pulmonary osteosacroma murine tumor models (i.e. K7M2), RNA-LPs induce robust anti-tumor efficacy in settings where immune checkpoint inhibitors (i.e. anti-PD-L1 therapy) do not confer therapeutic benefit. The investigators have already demonstrated safety of RNA-LPs in acute/chronic murine toxicity studies, and in client-owned canine trial. In this study, we will investigate the manufacturing feasibility, safety and immunologic activity of RNA-LP vaccine in patients with recurrent pulmonary or unresectable osteosarcoma and recurrent pHGG.
Primary Outcome
Determine the maximum tolerated dose of RNA-LP vaccine based on frequency of dose-limiting toxicities.
Conditions Studied
Interventions
- BIOLOGICAL pp65 RNA LP (DP1)
- BIOLOGICAL pp65/tumor mRNA RNA-LP (DP2)
- PROCEDURE Surgical Biopsy/Resection
Study Locations (1)
Florida
- UF Health - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-03-12 |
| Est. Completion | 2035-10 |
| Phase | Phase 1 |
What the registry record for NCT05660408 still lists
NCT05660408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, above the 28-participant average among 4 other Recurrent High Grade Glioma trials with a reported enrollment target (29% higher).
The record links to 2 conditions, with Recurrent High Grade Glioma appearing as the primary indexed condition, and to 3 interventions - of which pp65 RNA LP (DP1) is the first listed.
NCT05660408 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05660408 about?
NCT05660408 is a clinical study titled "RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors". The Investigators have demonstrated in preclinical studies that RNA liposomes activate APCs, induce antigen-specific T cell immunity, and can supplant DCs in a cell therapy model for HGG and have shown feasibility and activity of this approach in preclinical models and in canine patients with a spon...
What is the current status of trial NCT05660408?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-03-12. Estimated completion is 2035-10.
What conditions does trial NCT05660408 study?
This clinical trial studies the following conditions: Recurrent High Grade Glioma, Recurrent Pulmonary Osteosarcoma.
What interventions are being tested in trial NCT05660408?
The interventions under investigation include: pp65 RNA LP (DP1) (BIOLOGICAL), pp65/tumor mRNA RNA-LP (DP2) (BIOLOGICAL), Surgical Biopsy/Resection (PROCEDURE).
Who is sponsoring clinical trial NCT05660408?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05660408 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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