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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 belowSelect...
I am 18 years old or older.
Select...
I have completed radiation therapy for my new diagnosis, with or without temozolomide.
Select...
I have started or finished 6 cycles of temozolomide for my cancer with a specific gene change.
Select...
I am able to care for myself but may not be able to do active work.
Select...
My cancer has grown despite completing standard treatments including radiation and possibly chemotherapy.
Select...
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:Select...
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
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.
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.
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,431 Total Patients Enrolled
40 Trials studying Glioblastoma
1,836 Patients Enrolled for Glioblastoma
Mustafa Khasraw, MBChB, MD, FRCP, FRACPPrincipal InvestigatorDuke University
6 Previous Clinical Trials
219 Total Patients Enrolled
3 Trials studying Glioblastoma
138 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've finished standard radiation for my new diagnosis, and followed temozolomide treatment based on my MGMT status.My side effects from previous cancer treatments are mild.My condition did not worsen during or within 4 weeks after radiation therapy.I have been taking 2 mg or more of dexamethasone daily for the last 14 days.I had cancer before but have been disease-free for over 2 years.I finished IV antibiotics for an infection less than a week ago, not including preventive ones.I am 18 years old or older.I have completed radiation therapy for my new diagnosis, with or without temozolomide.I have not had any brain bleeding in the last 6 months.I have started or finished 6 cycles of temozolomide for my cancer with a specific gene change.I am able to care for myself but may not be able to do active work.My cancer has grown despite completing standard treatments including radiation and possibly chemotherapy.My brain tumor is a grade IV glioma with a specific EGFR mutation.
Research Study Groups:
This trial has the following groups:- Group 1: hEGFRvIII-CD3 (BRiTE) infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.