eligibility_summary
Inclusion: Adults (≥18) with newly diagnosed IDH1/2–wildtype, MGMT-unmethylated GBM, completed standard RT±TMZ, ECOG/WHO ≤2, lesion coverable by sonication, MRI-capable, tissue available, adequate organ/bone marrow, contraception, consent/compliance, no prior immunotherapy. Exclusion: multifocal/posterior fossa (unless within 50 mm), uncontrolled epilepsy/illness, checkpoint inhibitor contraindication, recent investigational agents, similar-drug allergy, other active cancer ≤12 mo, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Sonocloud-9 implant (9 ultrasound emitters) plus IV microbubbles to transiently open the blood–brain barrier (BBB) every 3 weeks, balstilimab (anti–PD-1 monoclonal antibody, 450 mg q3w), botensilimab (Fc‑enhanced anti–CTLA-4 monoclonal antibody, 1 mg/kg q6w), liposomal doxorubicin (anthracycline chemotherapy, 30 mg q3w). Mechanisms: Ultrasound/microbubble BBB opening increases intratumoral delivery. Balstilimab blocks PD‑1 on T cells to restore effector function. Botensilimab blocks CTLA‑4 to enhance T‑cell priming and deplete intratumoral Tregs via Fc‑mediated cytotoxicity. Liposomal doxorubicin kills tumor cells via DNA intercalation/topoisomerase II inhibition and can induce immunogenic cell death. Targets: BBB endothelial tight junctions, PD‑1/CTLA‑4 checkpoints on T cells (CD8+ and Tregs), glioblastoma cells.