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NCT03330197 · ClinicalTrials.gov registry record · Phase 1
A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG
A Phase 1 study, sponsored by Alaunos Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03330197: Clinical Trial Phase 1 study, sponsored by Alaunos Therapeutics.
NCT03330197 is a Phase 1 study that was terminated before completion, run by Alaunos Therapeutics. 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
NCT03330197, a Phase 1 study, was terminated before completion, sponsored by Alaunos Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex in the pediatric population.
Primary Outcome
Dose Limiting Toxicities are defined as events that occur during the first 28 days (Day 0 - Day 28) that meets one of the following criteria: * Any local reaction that requires operative intervention and is felt to be attributable to study drug * Any local reaction that has life-threatening consequences requiring urgent intervention or results in death and is felt to be attributable to study drug * Any Grade 3 or higher non-hematologic adverse event that is at least possibly related to study dr
Interventions
- BIOLOGICAL Ad-RTS-hIL-12
- DRUG Oral Veledimex - Arm 1 (Pediatric Brain Tumor)
- DRUG Oral Veledimex - Arm 2 (DIPG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2021-09-10 |
| Phase | Phase 1 |
Why NCT03330197 stopped before completion
NCT03330197 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 3 interventions - of which Ad-RTS-hIL-12 is the first listed.
NCT03330197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03330197 about?
NCT03330197 is a clinical study titled "A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG". This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to...
What is the current status of trial NCT03330197?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-09-26. Estimated completion is 2021-09-10.
What interventions are being tested in trial NCT03330197?
The interventions under investigation include: Ad-RTS-hIL-12 (BIOLOGICAL), Oral Veledimex - Arm 1 (Pediatric Brain Tumor) (DRUG), Oral Veledimex - Arm 2 (DIPG) (DRUG).
Who is sponsoring clinical trial NCT03330197?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03330197'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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