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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07343986
Phase
PHASE1
Status
Recruiting
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Conditions

  • Glioblastoma (GBM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • anti-EGFR bispecific-armed T cells — DRUG
    IN PROGRESS
  • Low-Intensity Focused Ultrasound — DEVICE
    Low-Intensity Focused Ultrasound will be used to open the blood-brain barrier

Study Details

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.

Key Dates

Start date
Mar 23, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Arm A will have Low-Intensity Focused Ultrasound (LIFU) after infusions 4 and 8.
  • Active Comparator: Arm B
    Arm B will have Low-Intensity Focused Ultrasound (LIFU) after infusions 1, 4 and 8.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Bettina Wagner, B.A.
[email protected]
434-243-7336
CJ Woodburn, B.S.
[email protected]
Camilo Fadul, M.D. (PRINCIPAL_INVESTIGATOR)

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University of Virginia· Charlottesville, VA

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