Ultrasound + Immunotherapy for Glioblastoma
(BATs FUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for glioblastoma, a type of brain cancer. It combines a special immunotherapy using anti-EGFR bispecific-armed T cells (a type of white blood cell that helps fight infections) with focused ultrasound to open the blood-brain barrier, which usually blocks treatments. The trial aims to determine if this combination is safe and can effectively reach the tumor. Individuals newly diagnosed with a specific type of glioblastoma who have undergone surgery to remove most of the tumor might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on anticoagulant therapy or ongoing immunosuppressive therapy, except for corticosteroids. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that using EGFR BATs, a type of immune cell therapy, to treat glioblastoma is generally safe. One study found that participants received the highest dose of EGFR BATs without major safety issues and experienced significant anti-tumor effects.
Research on low-intensity focused ultrasound (LIFU) has shown it is also safe. LIFU has been used to open the blood-brain barrier, a protective layer around the brain, without causing serious side effects. Some mild effects, like tiny red spots on the skin, have been reported but are not serious.
Overall, previous studies indicate that both EGFR BATs and LIFU treatments have been well-tolerated. This suggests they are safe for human use, although the current study will provide more insights into their combined effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using anti-EGFR bispecific-armed T cells for glioblastoma because it represents a different approach compared to the current standard treatments, which typically include surgery, radiation, and chemotherapy. Most treatments work by directly attacking cancer cells or slowing their growth. However, this new treatment uses a type of immunotherapy that targets the epidermal growth factor receptor (EGFR), a protein often overexpressed in glioblastoma, potentially increasing the precision and effectiveness of the attack on cancer cells. Additionally, combining this with Low-Intensity Focused Ultrasound (LIFU) could enhance the delivery and impact of the treatment, opening new avenues for fighting this aggressive form of brain cancer.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
Research has shown that a new type of immune cell treatment, called anti-EGFR bispecific-armed T cells, may help treat glioblastoma, a type of brain cancer. One study found that patients lived 63.6% longer on average compared to those who did not receive this treatment. These T cells have also destroyed up to 85% of certain glioblastoma cells in lab tests.
In this trial, participants will receive anti-EGFR bispecific-armed T cells combined with low-intensity focused ultrasound (LIFU). LIFU is another promising approach that can help deliver drugs more effectively to brain tumors. Clinical studies have shown that using LIFU can help some patients with glioblastoma live without the disease worsening for up to 14 months. Together, these treatments aim to boost the immune system's ability to attack tumor cells and improve how treatments reach the brain. Participants in Arm A will receive LIFU after infusions 4 and 8, while those in Arm B will receive LIFU after infusions 1, 4, and 8.12467Who Is on the Research Team?
Camilo Fadul, M.D.
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for patients with a new diagnosis of MGMT unmethylated IDH wild-type glioblastoma. Participants will use their own activated T-cells, modified to target the tumor, in combination with ultrasound therapy designed to enhance treatment delivery across the blood-brain barrier.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive infusions of EGFR BATs and undergo Low-Intensity Focused Ultrasound (LIFU) for blood-brain barrier opening
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- anti-EGFR bispecific-armed T cells
- Low-Intensity Focused Ultrasound
Trial Overview
The study tests if low-intensity focused ultrasound can improve brain tumor treatment by making it easier for engineered immune cells (EGFR-BATs) to enter the brain. Patients are divided into two groups; one receives more frequent ultrasound treatments than the other to see which is better at allowing these special cells into the tumor area.
How Is the Trial Designed?
2
Treatment groups
Active Control
Arm A will have Low-Intensity Focused Ultrasound (LIFU) after infusions 4 and 8.
Arm B will have Low-Intensity Focused Ultrasound (LIFU) after infusions 1, 4 and 8.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Focused Ultrasound Foundation
Collaborator
NaviFUS Corporation
Industry Sponsor
Citations
Efficacy and safety of low- and high-intensity focused ...
LIFU with carboplatin yielded progression-free survival (PFS) of 2.5–4.11 months and overall survival (OS) of 10.0–14.0 months, with subgroups ...
2.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov/41507561/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1hwQrn1DrkW0IYY-TwhK_LY_mvFnh6IJgOvHT5n5q3-hOpjgyk&fc=None&ff=20260113183212&v=2.18.0.post22+67771e2and high-intensity focused ultrasound in glioblastoma: a ...
Efficacy and safety of low- and high-intensity focused ultrasound in glioblastoma: a systematic review of preclinical and clinical studies.
3.
medschool.umaryland.edu
medschool.umaryland.edu/news/2025/clinical-trial-using-focused-ultrasound-with-chemotherapy-finds-potential-survival-benefit-for-brain-cancer-patients.html2025 Archives - Clinical Trial Using Focused Ultrasound ...
Results were published in the journal Lancet Oncology and show that trial participants had nearly 14 months of median progression-free survival, ...
Glioblastoma
Focused ultrasound is a noninvasive therapy that is transforming the treatment and quality of life for patients with glioblastoma.
5.
braintumorcenter.ucsf.edu
braintumorcenter.ucsf.edu/news/new-focused-ultrasound-clinical-trial-recurrent-glioblastomaNew Focused Ultrasound Clinical Trial for Recurrent ...
Preliminary findings from a phase I study in patients with recurrent glioblastoma showed that after focused ultrasound, carboplatin levels were 5.9 times higher ...
6.
fusfoundation.org
fusfoundation.org/posts/glioblastoma-clinical-trial-focused-ultrasound-blood-brain-barrier-opening-is-safe-provides-possible-survival-benefit/Glioblastoma Clinical Trial: Focused Ultrasound Blood ...
Data from a proof-of-concept study show that it is safe to use focused ultrasound blood-brain barrier opening before chemotherapy in patients ...
Study of Low-Intensity Focused Ultrasound in Combination ...
This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening ...
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