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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 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.
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.
Interventions
- DRUG hEGFRvIII-CD3 (BRiTE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-08 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04903795
The ClinicalTrials.gov registry entry for NCT04903795 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mustafa Khasraw, MBChB, MD, FRCP, FRACP, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which hEGFRvIII-CD3 (BRiTE) is the first listed.
NCT04903795 reports 0 study locations.
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.
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