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BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma

ConditionsNewly Diagnosed GlioblastomaRecurrent Glioblastoma
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: hEGFRvIII-CD3 (BRiTE) infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Proportion of patients with DLT within each dose level

Time frame
Begins with the infusion of BRiTE during Cycle 1 and goes through 28 days from the time of initiation of the infusion

Secondary outcomes

1

Objective response rate (ORR)

ORR per Response Assessment in Neuro-Oncology Criteria (RANO 2.0)

Time frame
8 weeks
2

Pharmacokinetic (PK) of BRiTE observed during Cycle 1 of BRiTE infusion

Changes in levels of BRiTE from baseline (prior to start of BRiTE infusion)

Time frame
Prior to initiation of Cycle 1 (each cycle is 28 days) of BRiTE infusion (baseline; on Day 0) till 1 hour after the end of infusion (on Day 4)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Lead sponsor

Duke University

Sponsor institution

Adaptin Bio

Collaborator

Source ClinicalTrials.gov
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