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NCT03927222 · ClinicalTrials.gov registry record · Phase 2

Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma

A Phase 2 study, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT03927222: Clinical Trial Phase 2 study, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.

NCT03927222 is a Phase 2 study that was terminated before completion, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03927222, a Phase 2 study, was terminated before completion, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have undergone definitive tumor resection, are cytomegalovirus (CMV) positive and unmethylated, and completed standard temozolomide (TMZ) and radiation treatment. After completion of the standard of care radiotherapy with concurrent TMZ, patients will receive 1 cycle of dose-intensified TMZ followed by pp65-loaded dendritic cell (DC) vaccination beginning on day 23.

Primary Outcome

Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up has OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.

Interventions

  • DRUG Temozolomide
  • BIOLOGICAL GM-CSF
  • BIOLOGICAL Tetanus-Diphtheria Toxoid (Td)
  • BIOLOGICAL Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF
  • BIOLOGICAL 111-Indium-labeling of Cells for in vivo Trafficking Studies

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2019-09-30
Est. Completion 2023-02-10
Phase Phase 2

Why NCT03927222 stopped before completion

NCT03927222 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.

NCT03927222 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03927222 about?

NCT03927222 is a clinical study titled "Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma". This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have undergone definitive tumor rese...

What is the current status of trial NCT03927222?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2019-09-30. Estimated completion is 2023-02-10.

What interventions are being tested in trial NCT03927222?

The interventions under investigation include: Temozolomide (DRUG), GM-CSF (BIOLOGICAL), Tetanus-Diphtheria Toxoid (Td) (BIOLOGICAL), Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF (BIOLOGICAL), 111-Indium-labeling of Cells for in vivo Trafficking Studies (BIOLOGICAL).

Who is sponsoring clinical trial NCT03927222?

This trial is sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03927222's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03927222, the US trial registry maintained by the National Library of Medicine. NCT03927222 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.