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NCT04254419 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells
A Phase 1 study of High Grade Glioma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04254419: Recruiting Phase 1 study of High Grade Glioma, sponsored by Nationwide Children's Hospital.
NCT04254419 is a Phase 1 study of High Grade Glioma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 18 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04254419, a Phase 1 study of High Grade Glioma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Each patient will receive up to 12 cycles of TGFβi NK cell infusions. Each cycle will be of 4 weeks duration. During the first 3 weeks, TGFβi NK cells will be infused once weekly. The 4th week will be a rest week. TGFβi NK cell infusions should be delivered at least 3 days apart (e.g., Friday of Week 1 and Monday of Week 2). Dose will be escalated in an inter-patient stepwise fashion consisting of 3 dose levels.
Primary Outcome
To determine the maximum tolerated dose (MTD) and/or the RP2D of UD TGFβi NK cells that have been propagated ex vivo with genetically modified feeder cells and administered using an Ommaya reservoir (into tumor cavity) or a programable ventriculoperitoneal shunt (intraventricular).
Conditions Studied
Interventions
- BIOLOGICAL NK cells
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-03-04 |
| Est. Completion | 2031-10 |
| Phase | Phase 1 |
What NCT04254419 shows while recruiting
NCT04254419 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 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (72% lower).
The record links to 1 condition, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which NK cells is the first listed.
NCT04254419 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04254419 about?
NCT04254419 is a clinical study titled "Phase 1 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells". Each patient will receive up to 12 cycles of TGFβi NK cell infusions. Each cycle will be of 4 weeks duration. During the first 3 weeks, TGFβi NK cells will be infused once weekly. The 4th week will be a rest week. TGFβi NK cell infusions should be delivered at least 3 days apart (e.g., Friday of Wee...
What is the current status of trial NCT04254419?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-03-04. Estimated completion is 2031-10.
What conditions does trial NCT04254419 study?
This clinical trial studies the following conditions: High Grade Glioma.
What interventions are being tested in trial NCT04254419?
The interventions under investigation include: NK cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04254419?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04254419 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for High Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04254419's enrollment target sits among peer trials
18 33rd of 42 higher than 8 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma 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.
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