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BRiTE Study for Glioblastoma

This study is testing a new treatment called hEGFRvIII-CD3 (BRiTE) for people with newly diagnosed or recurrent glioblastoma (a type of brain tumor). BRiTE is a "bispecific T cell engager," meaning it helps your body's immune cells (T cells) find and attack tumor cells that have a specific marker called EGFRvIII. To join, you must have glioblastoma with this EGFRvIII mutation. The main goal of this Phase 1 study is to see how safe BRiTE is and to find the highest dose that can be given safely. BRiTE will be given continuously through an IV for 4 days in a 28-day cycle. The study plans to enroll up to 18 patients.

Study design
This is a Phase 1 interventional study, meaning it's an early-stage study to test safety. It plans to enroll a maximum of 18 participants.
What's involved
You would receive hEGFRvIII-CD3 (BRiTE) continuously through an IV for 4 days (96 hours) in a 28-day cycle. The primary safety measurement will be taken during the first 28 days of treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoint, dose-limiting toxicity (DLT), is measured during the first 28 days from the start of the BRiTE infusion.

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NCT04903795

BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
~18 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:hEGFRvIII-CD3 (BRiTE)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT)
Measured over Begins with the infusion of BRiTE during Cycle 1 and goes through 28 days from the time of initiation of the infusion

Conditions

Newly Diagnosed Glioblastoma
Recurrent Glioblastoma

Explore related trials

GlioblastomaEGFR NP_005219.2:p.K29_N298insG

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Mustafa Khasraw, MBChB, MD, FRCP, FRACP · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Mustafa Khasraw, MBChB, MD, FRCP, FRACP
[email protected]
9196845301
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Typically, 59.4-60 Gy over approximately 6 weeks duration, if under 65 years old
A minimum of 40 Gy over 3 weeks duration, if 65 years or older 5. Patients who progress during RT or within 4 weeks after completion of RT are not eligible.

What this trial measures

  • Dose-limiting toxicity (DLT)Begins with the infusion of BRiTE during Cycle 1 and goes through 28 days from the time of initiation of the infusion

    Proportion of patients with DLT within each dose level