MedTrace Logo

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

NCT05864534 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-13

No results posted yet for this study

Summary

Brain tumor treatment is hampered by the blood-brain barrier (BBB). This barrier prevents drugs carried in the bloodstream from getting into the brain. If the BBB can be opened, making it temporarily more permeable, drugs may able to better reach the brain tumor. In this trial we will implant a novel device with 9 ultrasound emitters, allowing temporary and reversible opening of the BBB to maximize brain penetration of drugs that modulate the immune system. The device will be implanted after radiation is completed. Immune modulating drugs will be given every 3 weeks in conjunction with activation of the device to open the BBB.

The objectives of this trial are to establish whether it is safe and feasible to administer immune modulating drugs in this manner, and identify whether the treatment is effective in treating glioblastoma.

Conditions

  • Gliosarcoma
  • Newly Diagnosed Glioblastoma
  • Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype
  • Glioblastoma Multiforme

Interventions

DRUG

Balstilimab

Balstilimab 450 mg IV over 30 minutes every 3 weeks

DRUG

Botensilimab

Botensilimab1mg/kg mg IV over 30 minutes every 6 weeks

DRUG

Liposomal Doxorubicin

Liposomal Doxorubicin 30 mg IV over 30 minutes every 3 weeks

DEVICE

Sonocloud-9 (SC-9)

Device activation of 9 ultrasound emitters during IV injection of microbubbles every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Adam Sonabend, MD · Northwestern University

  • Roger Stupp, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-19
Primary Completion
2031-07-31
Completion
2031-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864534 on ClinicalTrials.gov