OncoMatch/Clinical Trials/NCT07343986
Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma
Is NCT07343986 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including anti-EGFR bispecific-armed T cells and Low-Intensity Focused Ultrasound for glioblastoma (gbm).
Treatment: anti-EGFR bispecific-armed T cells · Low-Intensity Focused Ultrasound — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: EGFR overexpression (score ≥ 1 by ihc)
Required: IDH1 wild-type
Required: MGMT unmethylated
Prior therapy
Must have received: surgery — newly diagnosed
Maximal surgical debulking of the tumor was performed where residual contrast enhancement is 2 cm3 or less on immediate post-operative MRI. Intraoperative post-resection MRI is acceptable.
Cannot have received: any treatment for GBM besides surgery
Has received any treatment for GBM besides surgery.
Cannot have received: biopsy only
Patients undergoing only biopsy (partial resection or greater is required).
Lab requirements
Blood counts
Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days before leukapheresis.
Kidney function
Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days before leukapheresis.
Liver function
Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days before leukapheresis.
Cardiac function
No recent (within one year) myocardial infarction or stroke; no current or prior history of angina/coronary symptoms requiring medications and/or a history of depressed left ventricular function (LVEF < 45%); no pacemaker; no clinical evidence of congestive heart failure requiring medical management.
Demonstrate adequate organ function as defined in Table 1. Cardiac Status: Patients will be ineligible for treatment on this protocol if (before protocol entry): 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. There is clinical evidence of congestive heart failure requiring medical management.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Virginia · Charlottesville, Virginia
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