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NCT04006119 · ClinicalTrials.gov registry record · Phase 2

Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma

A Phase 2 study, sponsored by Alaunos Therapeutics.

Terminated
Registry status
Phase 2
Development phase
40
Enrollment target

NCT04006119 is a Phase 2 study that was terminated before completion, run by Alaunos Therapeutics. The registered enrollment target is 40 participants.

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The verdict

NCT04006119, a Phase 2 study, was terminated before completion, sponsored by Alaunos Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
40 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. Cemiplimab-rwlc (Libtayo) is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Libtayo (cemiplimab-rwlc) is currently FDA approved in the United States for metastatic cutaneous cell carcinoma (CSCC), but is not approved in glioblastoma. Cemiplimab-rwlc may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with cemiplimab-rwlc to enhance the IL-12 mediated effect observed to date. The main purpose of this study is to evaluate the safety and efficacy of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with cemiplimab-rwlc.

Interventions

  • DRUG Cemiplimab-Rwlc
  • BIOLOGICAL Ad-RTS-hIL-12
  • DRUG Veledimex

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-08-01
Est. Completion 2021-08-05
Phase Phase 2

Sponsor

Alaunos Therapeutics

22 total trials

What the Registry Record Tells You About NCT04006119

The ClinicalTrials.gov registry entry for NCT04006119 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alaunos Therapeutics, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Cemiplimab-Rwlc is the first listed.

NCT04006119 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04006119 about?

NCT04006119 is a clinical study titled "Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma". 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 NCT04006119?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2019-08-01. Estimated completion is 2021-08-05.

What interventions are being tested in trial NCT04006119?

The interventions under investigation include: Cemiplimab-Rwlc (DRUG), Ad-RTS-hIL-12 (BIOLOGICAL), Veledimex (DRUG).

Who is sponsoring clinical trial NCT04006119?

This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.