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Study of Low-Intensity Focused Ultrasound with Immunotherapy for Glioblastoma

This study is testing a new approach for people with newly diagnosed glioblastoma (a type of brain cancer) that is unmethylated and IDH wildtype, and expresses EGFR. It combines a drug called anti-EGFR bispecific-armed T cells with Low-Intensity Focused Ultrasound. The ultrasound is used to temporarily open the blood-brain barrier (a protective layer around the brain) to help the drug reach the tumor better. Researchers want to see how safe this combination is and if it's possible to give the recommended dose of the drug. They will also track any side effects. You may be able to join if you are between 18 and 70 years old, have a good performance status, and your tumor meets specific criteria. This study plans to enroll 12 participants.

Study design
This is a Phase 1 interventional study, which means it's an early-stage study focused on safety. It plans to include 12 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The safety and feasibility of the treatment will be evaluated at 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07343986

Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma

Recruiting
PHASE1Ages 18–70InterventionalTreatment
University of Virginia
~12 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:anti-EGFR bispecific-armed T cellsLow-Intensity Focused Ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The safety of this treatment will be evaluated through the number of participants experiencing Grade ≥3 dose-limiting toxicities (DLTs).
Measured over 8 weeks
+3 more outcomes measured

Conditions

Glioblastoma (GBM)

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Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Camilo Fadul, M.D. · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Bettina Wagner, B.A.
[email protected]
434-243-7336
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

There is a history of a recent (within one year) myocardial infarction or stroke.
There is a current or prior history of angina/coronary symptoms requiring medications and/or a history of depressed left ventricular function (LVEF \< 45%).
Patient has a pacemaker. 17. There is clinical evidence of congestive heart failure requiring medical management. 18. Has Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). 19. Has received a live vaccine within 30 days of leukapheresis. 20. Has received any treatment for GBM besides surgery. 21. Females must not be pregnant or breastfeeding. 22. Ongoing immunosuppressive therapy except for corticosteroids 23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 24. A patient may be excluded if, in the opinion of the treating investigator, the patient is not capable of being compliant.

What this trial measures

  • The safety of this treatment will be evaluated through the number of participants experiencing Grade ≥3 dose-limiting toxicities (DLTs).8 weeks

    The safety will be evaluated by determining the number of participants who experience Grade ≥3 DLTs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during EGFR BAT and LIFU BBB opening after RT/TMZ. The scale displays Grades 1 through 5 and refers to the severity of the AE. A higher grade (e.g., 5) represents a worse outcome.

  • The feasibility of this treatment will be determined by the proportion of participants achieving ≥75% of the recommended EGFR BATs dose8 weeks

    The feasibility of this treatment will be determined by calculating the proportion of participants achieving ≥75% (60 x 10\^9 EGFR BATs) of the recommended Phase II EGFR BAT dose.

  • Incidence and severity of treatment-emergent adverse events (AEs) based on physical examination, vital signs, laboratory parameters, serum chemistry and hematology8 weeks

    Safety will be quantified using AE counts and severity grading per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Physical examinations, vital signs, and laboratory studies will be recorded.

  • Brain uptake of 89Zr-oxine-labeled EGFR BATs measured by PET standardized uptake values (SUV) with and without LIFU BBB opening8 weeks

    Three PET imaging scans will be taken to quantify trafficking of labeled EGFR BATs into the GBM microenvironment. PET signal (SUV) will be compared across time points and between LIFU BBB-opened and non-opened regions.