What side effects are associated with this type of intervention?

Common side effects of treatments for Glioblastoma, especially those involving immunotherapies like Bispecific T cell engagers targeting EGFRvIII and CD3, include cytokine release syndrome (CRS), which can cause fever, fatigue, and muscle pain. Other potential side effects are neurotoxicity, leading to headaches, confusion, or seizures, and hematologic toxicities such as neutropenia and anemia. Additionally, patients may experience gastrointestinal symptoms like nausea and diarrhea, as well as skin reactions at the injection site.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, an oral chemotherapy drug, and bevacizumab, an anti-angiogenic therapy. While there are no FDA-approved treatments specifically targeting EGFRvIII with a Bispecific T cell engager like BRiTE, ongoing research and clinical trials are exploring novel immunotherapies and targeted treatments. These include various forms of CAR T-cell therapies and other bispecific antibodies aimed at enhancing the immune system's ability to target and destroy glioblastoma cells.

What other types of research exist?

Promising novel alternatives to BRiTE for Glioblastoma patients include: 1) CAR T-cell therapies targeting EGFRvIII or other glioblastoma-specific antigens, 2) Oncolytic virus therapies such as DNX-2401, 3) Immune checkpoint inhibitors like pembrolizumab combined with other agents, and 4) Tumor Treating Fields (TTF) in combination with standard therapies. These alternatives are currently being explored in clinical trials and have shown potential in improving outcomes for glioblastoma patients.

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CAR T-cell Therapy

BRiTE for Glioblastoma (BRiTE Trial)

Phase 1

Waitlist Available

Led By Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Completion of standard of care radiation therapy with or without temozolomide for newly diagnosed patients

Must not have

Patients on corticosteroids ≥ 2 mg dexamethasone daily within 14 days of 1st BRiTE injection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 hours post brite injection

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called BRiTE for patients with aggressive brain cancer that have a specific mutation. BRiTE helps the immune system recognize and destroy cancer cells by connecting immune cells directly to the cancer.

Who is the study for?

Adults with Grade IV malignant glioma and EGFRvIII mutation, who've completed standard radiation therapy. Eligible if KPS is ≥70%, liver function is adequate, not pregnant or breastfeeding, no recent severe infections or unresolved toxicities from previous treatments (except stable conditions like hair loss), and willing to use effective birth control.

What is being tested?

The trial tests a new cancer treatment called BRiTE for patients with specific brain tumors. It's in phase 1 to check safety. Patients must have the EGFRvIII mutation and meet certain health criteria to join.

What are the potential side effects?

Potential side effects of BRiTE are not detailed here but may include reactions related to immune system activation given its nature as an immunotherapy agent. Side effects could range from mild infusion-related symptoms to more serious organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have completed radiation therapy for my new diagnosis, with or without temozolomide.

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I have started or finished 6 cycles of temozolomide for my cancer with a specific gene change.

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I am able to care for myself but may not be able to do active work.

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My cancer has grown despite completing standard treatments including radiation and possibly chemotherapy.

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My brain tumor is a grade IV glioma with a specific EGFR mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking 2 mg or more of dexamethasone daily for the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 hours post brite injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 hours post brite injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 hours post brite injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicity (DLT)

Secondary study objectives

Objective response rate (ORR)

Pharmacokinetic (PK) of BRiTe observed during the injection of BRiTE

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: hEGFRvIII-CD3 (BRiTE) infusionExperimental Treatment1 Intervention

Four escalating doses of BRiTE are planned: #1: 57.0 ng/kg, #2: 570.0 ng/kg, #3: 5700.0 ng/kg, and #4: 57000.0 ng/kg.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments often include surgery, radiation therapy, and chemotherapy with agents like temozolomide, which damages the DNA of cancer cells, leading to cell death. Targeted therapies, such as EGFR inhibitors, aim to block the signals that promote tumor growth. The BRiTE trial investigates a Bispecific T cell engager that targets EGFRvIII and CD3, which works by directing the patient's T cells to attack tumor cells expressing the EGFRvIII mutation. This approach is significant for Glioblastoma patients as it offers a more precise attack on cancer cells, potentially improving treatment efficacy and reducing damage to healthy tissues.