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Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
NCT05864534 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Balstilimab
- DRUG Liposomal Doxorubicin
- DRUG Botensilimab
- DEVICE Sonocloud-9 (SC-9)
Study Locations (1)
Illinois
- Northwestern University — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05864534
The ClinicalTrials.gov registry entry for NCT05864534 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,033 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 4 interventions — of which Balstilimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05864534 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05864534 about?
NCT05864534 is a clinical study titled "Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma". 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 nove...
What is the current status of trial NCT05864534?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2024-01-31. Estimated completion is 2026-08.
What conditions does trial NCT05864534 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma, Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05864534?
The interventions under investigation include: Balstilimab (DRUG), Liposomal Doxorubicin (DRUG), Botensilimab (DRUG), Sonocloud-9 (SC-9) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05864534?
This trial is sponsored by Northwestern University, which has 1,033 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05864534 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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