Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

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

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma (NCT05864534) is a Phase 2 interventional studying Newly Diagnosed Glioblastoma and Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype, sponsored by Northwestern University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Newly Diagnosed Glioblastoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2 wild-type - Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated - Available paraffin embedded tumor tissue for the study - Have completed standard radiotherapy with or without temozolomide - 18 years of age or older - Able to undergo contrast-enhanced MRI - Have an Eastern Cooperative Oncology Group/World Health Organization performance status ≤ 2 - Size and location of the residual tumor and/or resection cavity must allow to be able to be covered by the sonication field - Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications - Have the ability to understand and willingness to sign a written willing to sign a consent form prior to registration on study. - Be willing and able to comply with the protocol. - Have adequate organ and bone marrow function - Agree to use adequate contraception if appropriate Who Should NOT Join This Trial: Patients will be ineligible if they have: - Multifocal tumor (unless all localized in a 50-mm diameter area accessible to ultrasound field) or tumor located in the posterior fossa. - Uncontrolled epilepsy. - Received other investigational agents within 2 weeks of registration - Received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study. - Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmune conditions (where your immune system attacks your own body)) - Uncontrolled illness - History of active malignancy other than the brain tumor within 12 months prior to registration. - Are pregnant or breastfeeding. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2 wild-type * Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated * Available paraffin embedded tumor tissue for the study * Have completed standard radiotherapy with or without temozolomide * 18 years of age or older * Able to undergo contrast-enhanced MRI * Have an Eastern Cooperative Oncology Group/World Health Organization performance status ≤ 2 * Size and location of the residual tumor and/or resection cavity must allow to be able to be covered by the sonication field * Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications * Have the ability to understand and willingness to sign a written informed consent prior to registration on study. * Be willing and able to comply with the protocol. * Have adequate organ and bone marrow function * Agree to use adequate contraception if appropriate Exclusion Criteria: Patients will be ineligible if they have: * Multifocal tumor (unless all localized in a 50-mm diameter area accessible to ultrasound field) or tumor located in the posterior fossa. * Uncontrolled epilepsy. * Received other investigational agents within 2 weeks of registration * Received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study. * Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmune disease) * Uncontrolled illness * History of active malignancy other than the brain tumor within 12 months prior to registration. * Are pregnant or breastfeeding.

Treatments Being Tested

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Northwestern University

Chicago, Illinois, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05864534), the sponsor (Northwestern University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05864534 clinical trial studying?

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 activat… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05864534?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05864534?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05864534. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05864534. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.