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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 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03334305
The ClinicalTrials.gov registry entry for NCT03334305 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which TTRNA-DC vaccines with GM-CSF is the first listed.
NCT03334305 reports 0 study locations.
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.
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