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

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

Trial Details

NCT ID
NCT07343986
Phase
PHASE1
Sponsor
University of Virginia
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • anti-EGFR bispecific-armed T cells
  • Low-Intensity Focused Ultrasound
Locations (sample)
  • Charlottesville, Virginia, United States|38.02931,-78.47668

Key Eligibility Criteria

  • Newly diagnosed supratentorial glioblastoma or gliosarcoma IDH wildtype and MGMT unmethylated that express EGFR (score ≥ 1 by IHC)) and confirmed b…
  • Age ≥ 18 and ≤ 70 years at the time of signing informed consent.
  • Karnofsky Performance Status (KPS) ≥ 70.
  • Be willing and able to provide written informed consent for the trial.

For full eligibility, visit ClinicalTrials.gov.

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