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NCT04963413 · ClinicalTrials.gov registry record · Phase 1
RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04963413 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 6 participants.
The verdict
NCT04963413, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
In prior trials of CMV RNA-pulsed dendritic cell vaccines, there has been a narrow window between surgery and initiation of chemoradiation to enroll patients and perform leukapheresis (to obtain cells needed to generate investigational vaccine). Patients who had started chemoradiation were not eligible to participate. In this study, the investigators propose to conduct a pilot study to evaluate the ability to generate pp65 full-length LAMP RNA-pulsed DCs in patients who have completed standard external beam radiation and concomitant temozolomide who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.
Interventions
- BIOLOGICAL Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-01-13 |
| Est. Completion | 2023-09-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04963413
The ClinicalTrials.gov registry entry for NCT04963413 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 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 1 intervention - of which Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF is the first listed.
NCT04963413 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04963413 about?
NCT04963413 is a clinical study titled "RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.". In prior trials of CMV RNA-pulsed dendritic cell vaccines, there has been a narrow window between surgery and initiation of chemoradiation to enroll patients and perform leukapheresis (to obtain cells needed to generate investigational vaccine). Patients who had started chemoradiation were not eligi...
What is the current status of trial NCT04963413?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-01-13. Estimated completion is 2023-09-28.
What interventions are being tested in trial NCT04963413?
The interventions under investigation include: Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF (BIOLOGICAL).
Who is sponsoring clinical trial NCT04963413?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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