BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMustafa Khasraw, MBChB, MD, FRCP, FRACP
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients who are pregnant or breastfeeding/chestfeeding
Patients with baseline corrected QT interval (QTc) > 480ms on screening electrocardiogram (ECG).
Known hypersensitivity to immunoglobulins or to any other component of BRiTE
Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate
Trial design
Treatments tested in this trial
- hEGFRvIII-CD3 (BRiTE)
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Lead sponsor
Duke University
Sponsor institution
Adaptin Bio
Collaborator
Source ClinicalTrials.gov