Glioblastoma Clinical Trial
Official title:
A Phase I Study of hEGFRvIII-CD3 Bi-scFv (BRiTE) in Patients With WHO Grade IV Malignant Glioma
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.
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. ;
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