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Clinical Trial Summary

This phase 1 study will evaluate a novel hEGFRvIII-CD3-biscFv Bispecific T cell engager (BRiTE) in patients diagnosed with pathologically documented World Health Organization (WHO) grade 4 malignant glioma (MG) with an EGFRvIII (epidermal growth factor receptor variant III) mutation (either newly diagnosed or at first progression/recurrence). The primary objective is to evaluate the safety of BRiTE in such patients.


Clinical Trial Description

A maximum of 18 patients with pathologically documented supratentorial WHO grade 4 malignant glioma with an EGFRvIII mutation (either newly diagnosed or at first progression/recurrence) will be treated in this study after undergoing standard of care radiation therapy (XRT) and providing informed consent. After completion of a minimum of 6 cycles of adjuvant temozolomide (TMZ), or at first progression, eligible patients will receive a bolus BRiTE injection followed by a 28-day safety monitoring period. Blood will be drawn to assess the pharmacokinetics (PKs) of BRiTE injection, as well as to investigate the immune system response to BRiTE injection and evaluate for cytokine release syndrome (CRS). Following the 28-day monitoring period, patients will be passively followed as part of their standard of care follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04903795
Study type Interventional
Source Duke University
Contact Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Phone 9196845301
Email dukebrain1@dm.duke.edu
Status Not yet recruiting
Phase Phase 1
Start date December 2026
Completion date December 2026

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