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NCT04903795 · ClinicalTrials.gov registry record · Phase 1

BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma

A Phase 1 study, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.

Not yet
Registry status
Phase 1
Development phase
18
Enrollment target

NCT04903795: Clinical Trial Phase 1 study, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.

NCT04903795 is a Phase 1 study that has not yet begun recruiting, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04903795, a Phase 1 study, has not yet begun recruiting, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This Phase 1 study will assess the safety of a novel brain Bispecific T cell engager (BRiTE) in patients with newly diagnosed or recurrent World Health Organization (WHO) Grade 4 glioblastoma (GBM). Owing to its short half-life, the study drug, BRiTE, will be continuously infused intravenously (IV) for 4 days (96 hours) in a 28-day cycle. Given that BRiTE specifically exerts its effects on tumor cells expressing the Epidermal Growth Factor Receptor variant III (EGFRvIII) mutation, we will only enroll patients with EGFRvIII-positive tumors in this study. The primary objective is to evaluate the safety and tolerability of continually infused BRiTE in ndGBM and rGBM patients and determine the maximum tolerated dose (MTD) for continuously infused BRiTE.

Primary Outcome

Proportion of patients with DLT within each dose level

Interventions

  • DRUG hEGFRvIII-CD3 (BRiTE)

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2026-08
Est. Completion 2027-12
Phase Phase 1

What is known before NCT04903795 opens enrollment

NCT04903795 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which hEGFRvIII-CD3 (BRiTE) is the first listed.

NCT04903795 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04903795 about?

NCT04903795 is a clinical study titled "BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma". This Phase 1 study will assess the safety of a novel brain Bispecific T cell engager (BRiTE) in patients with newly diagnosed or recurrent World Health Organization (WHO) Grade 4 glioblastoma (GBM). Owing to its short half-life, the study drug, BRiTE, will be continuously infused intravenously (IV) ...

What is the current status of trial NCT04903795?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-08. Estimated completion is 2027-12.

What interventions are being tested in trial NCT04903795?

The interventions under investigation include: hEGFRvIII-CD3 (BRiTE) (DRUG).

Who is sponsoring clinical trial NCT04903795?

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 NCT04903795's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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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Source: ClinicalTrials.gov NCT04903795, the US trial registry maintained by the National Library of Medicine. NCT04903795 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.