BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Study ID
NCT04903795
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • hEGFRvIII-CD3 (BRiTE) — DRUG
    Bispecific T cell engager possessing one effector binding arm specific for the epsilon subunit of CD3 (a signaling molecule complex associated with the T cell receptor on T cells) while the opposing target-binding arm is directed against the hEGFRvIII epitope that is differentially expressed on the surface of tumor cells

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: hEGFRvIII-CD3 (BRiTE) infusion
    Five escalating doses of continuously-infused BRiTE are planned: #1: 0.91 mcg/kg/day , #2: 2.88 mcg/kg/day, #3: 9.10 mcg/kg/day, #4: 28.78 mcg/kg/day, and #5: 91.00 mcg/kg/day.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
[email protected]
9196845301
Stevie Threatt, BA
[email protected]
9196845301
Mustafa Khasraw, MBChB, MD, FRCP, FRACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Duke University Medical Center· Durham, NC

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