Ultrasound + Immunotherapy for Glioblastoma
(BATs FUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-intensity focused ultrasound would induce blood-brain barrier opening and increase the permeability of the adoptive immunotherapy. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.
Who 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
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.