Recruiting
Phase 2

Immune Modulation

Sponsor:

Northwestern University

Code:

NCT05864534

Conditions

Newly Diagnosed Glioblastoma

Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype

Gliosarcoma

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Balstilimab

Botensilimab

Liposomal Doxorubicin

Sonocloud-9 (SC-9)

Study Details

Brief 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

Newly Diagnosed Glioblastoma

Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype

Gliosarcoma

Glioblastoma Multiforme

Study ID

NCT05864534

Start date

Jan 19, 2024

Status verified date

Aug, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Jul 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blood-brain barrier opening with concomitant BAL, BOT, DOX

Patients will undergo implantation of Sonocloud-9 after completion of radiotherapy. Within 21 days after implant, ultrasound-based BBB opening with concomitant administration of DOX (30 mg) + BAL (450 mg) every 3 weeks, and BOT (dose 1mg/kg) every 6 weeks will be initiated.

Interventions

Balstilimab

Balstilimab 450 mg IV over 30 minutes every 3 weeks

Botensilimab

Botensilimab1mg/kg mg IV over 30 minutes every 6 weeks

Liposomal Doxorubicin

Liposomal Doxorubicin 30 mg IV over 30 minutes every 3 weeks

Sonocloud-9 (SC-9)

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

Primary outcome measure

  • Unacceptable toxicity rate [ Time Frame: 42 days ]
  • Landmark survival analyses [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Neurological Surgery

(312) 695-8143braintumortrials@nm.org

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Neurological Surgery

(312) 695-8143braintumortrials@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Immunotherapy
  • Ultrasound
  • Blood-brain barrier
  • Sonocloud
  • Balstilimab (BAL)
  • Botensilimab (BOT)
  • Doxorubicin (DOX)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-14.