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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hours post brite injection
Awards & highlights

BRiTE Trial Summary

This trial is testing a new cancer treatment for patients with a certain type of brain tumor. The treatment involves using the patient's own immune cells to attack the tumor. The goal is to see if the treatment is safe and effective.

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.Check my eligibility
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.See study design
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.

BRiTE Trial 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.

BRiTE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity (DLT)
Secondary outcome measures
Objective response rate (ORR)
Pharmacokinetic (PK) of BRiTe observed during the injection of BRiTE

BRiTE 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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,052 Total Patients Enrolled
39 Trials studying Glioblastoma
1,643 Patients Enrolled for Glioblastoma
Mustafa Khasraw, MBChB, MD, FRCP, FRACPPrincipal InvestigatorDuke University
6 Previous Clinical Trials
197 Total Patients Enrolled
3 Trials studying Glioblastoma
116 Patients Enrolled for Glioblastoma

Media Library

hEGFRvIII-CD3 (BRiTE) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04903795 — Phase 1
Glioblastoma Research Study Groups: hEGFRvIII-CD3 (BRiTE) infusion
Glioblastoma Clinical Trial 2023: hEGFRvIII-CD3 (BRiTE) Highlights & Side Effects. Trial Name: NCT04903795 — Phase 1
hEGFRvIII-CD3 (BRiTE) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903795 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA ratified hEGFRvIII-CD3 (BRiTE) for use yet?

"Taking into account the preliminary nature of Phase 1 trials, our team at Power has rated hEGFRvIII-CD3 (BRiTE) a 1 on the safety scale. This is because there is limited data available to support its efficacy and security."

Answered by AI

Is entry into this trial currently available to those wishing to participate?

"The clinicaltrials.gov website reveals that this medical research, which was first posted on May 1st 2023, is not presently recruiting patients for participation. Nonetheless, there are a plethora of other trials currently enrolling individuals at present."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Bispecific T Cell Engager BRiTE for Patients With Grade IV Malignant Glioma
2024. "Bispecific T Cell Engager BRiTE for Patients With Grade IV Malignant Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903795.
~12 spots leftby Dec 2024
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