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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: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT04963413 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of patients who are able to generate at least 3 CMV pp65 RNA-pulsed DCs vaccines
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 |
Why NCT04963413 stopped before completion
NCT04963413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04963413's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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