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RECRUITING
NCT05864534
PHASE2

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Official title: A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-01-31

Completion Date

2026-08

Last Updated

2025-10-03

Healthy Volunteers

No

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

Locations (1)

Northwestern University

Chicago, Illinois, United States