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NCT03679754 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
A Phase 1 study of Glioblastoma, sponsored by Alaunos Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT03679754: Completed Phase 1 study of Glioblastoma, sponsored by Alaunos Therapeutics.
NCT03679754 is a Phase 1 study of Glioblastoma that has completed, run by Alaunos Therapeutics. The registered enrollment target is 36 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (67% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03679754, a Phase 1 study of Glioblastoma, has completed, sponsored by Alaunos Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
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 intratumoral injection of Ad-RTS-hIL-12 given with oral veledimex.
Primary Outcome
Evaluation of adverse events as assessed by CTCAE v4.03. Adverse events will be summarized based on the incidence, intensity and type of adverse event.
Conditions Studied
Interventions
- BIOLOGICAL Ad-RTS-hIL-12
- DRUG veledimex
Study Locations (4)
California
- Cedars-Sinai Medical Center - Los Angeles
Illinois
- Northwestern Memorial Hospital - Chicago
New York
- NYU - Langone Health - New York
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2021-01-19 |
| Phase | Phase 1 |
What the finished NCT03679754 record still lists
NCT03679754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Ad-RTS-hIL-12 is the first listed.
NCT03679754 reports a single indexed study location in California, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT03679754 about?
NCT03679754 is a clinical study titled "Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102". 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 NCT03679754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-09-05. Estimated completion is 2021-01-19.
What conditions does trial NCT03679754 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT03679754?
The interventions under investigation include: Ad-RTS-hIL-12 (BIOLOGICAL), veledimex (DRUG).
Who is sponsoring clinical trial NCT03679754?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03679754 being conducted?
This trial has 4 study locations across California, Illinois, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03679754's enrollment target sits among peer trials
36 115th of 199 higher than 83 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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