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NCT03334305 · ClinicalTrials.gov registry record · Phase 1
Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03334305: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT03334305 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03334305, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
It is believed that the body's immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use a patient's tumor to make a vaccine which we hope will stimulate T-cells to kill tumor cells and leave normal cells alone. High grade gliomas (HGGs) are very aggressive and difficult for the body's immune system to attack. Before T-cells can become active against tumor cells, they require strong stimulation by special "stimulator" cells in the body called Dendritic Cells (DCs) which are also part of the immune system. DCs can recognize the cancer cells and then activate the T lymphocytes, and create this strong stimulation. The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC vaccines can be given safely. Most importantly, this study is also to determine whether the T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells in the brain.
Primary Outcome
Percentage of subjects with grade 3 or greater adverse events. Adverse events (AEs) were summarized in the safety population (N = 5) at the participant level. For each AE term, a participant was counted once using the maximum observed CTCAE grade. Recurrent occurrences of the same AE in a participant were not counted multiple times.
Interventions
- BIOLOGICAL TTRNA-DC vaccines with GM-CSF
- BIOLOGICAL TTRNA-xALT
- DRUG Td vaccine
- BIOLOGICAL Autologous Hematopoietic Stem cells (HSCs)
- DRUG Dose-intensified TMZ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2025-03-20 |
| Phase | Phase 1 |
Why NCT03334305 stopped before completion
NCT03334305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which TTRNA-DC vaccines with GM-CSF is the first listed.
NCT03334305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03334305 about?
NCT03334305 is a clinical study titled "Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas". It is believed that the body's immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated e...
What is the current status of trial NCT03334305?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-08-27. Estimated completion is 2025-03-20.
What interventions are being tested in trial NCT03334305?
The interventions under investigation include: TTRNA-DC vaccines with GM-CSF (BIOLOGICAL), TTRNA-xALT (BIOLOGICAL), Td vaccine (DRUG), Autologous Hematopoietic Stem cells (HSCs) (BIOLOGICAL), Dose-intensified TMZ (DRUG).
Who is sponsoring clinical trial NCT03334305?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03334305's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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