BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma

Inclusion criteria

• ✓. Age ≥ 18 years old at the time of entry into the study
• ✓. For both newly diagnosed and recurrent patients, pathologically documented supratentorial WHO grade 4 GBM with a confirmed EGFRvIII mutation at the most recent diagnosis, with radiographic contrast enhancing disease that is ≤ 4 cm in maximal diameter in any plane before resection.
• ✓. Patients with methylated MGMT promoter status should have received standard of care concomitant RT and TMZ, followed by 6 cycles of adjuvant TMZ, before they can participate in this study
• ✓. Patients with an unmethylated MGMT promoter status should have received standard of care RT, but need not have received concomitant TMZ or 6 cycles of adjuvant TMZ and can be enrolled after 4 weeks from completion of standard of care RT
• ✓. Patients whose MGMT status is unknown or indeterminate will be treated as though they have a methylated MGMT promotor status for eligibility purposes
• ✓. RT for 3 or 6-week courses are accepted as follows:
• ✓. Patients who progress during RT or within 4 weeks after completion of RT are not eligible.
• ✓. Karnofsky Performance Score (KPS) ≥ 70%

Exclusion criteria