eligibility_summary
Inclusion: ≥18, KPS ≥70, LE ≥3 mo, MRI‑proven recurrent supratentorial HGG (GBM 1st recurrence—Sched 4/4a) post radiation+temozolomide, surgery planned with no cavity‑ventricle connection, labs: ANC ≥1000, Plt ≥100k, bili ≤2, AST ≤4×ULN, Cr ≤ULN, washouts: targeted ≥2 wk, bev ≥4 wk, TMZ 23 days, prior AEs resolved, consent, contraception/negative test. Exclusion: multifocal disease, on therapy, prior neural stem cells, >G1 AEs, cannot MRI, CNS viral infection, coagulopathy, uncontrolled illness/other cancer, pregnant/breastfeeding, serious medical/psychiatric illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05139056 (Phase I). Intervention: NSC-CRAd-S-pk7, a biological, cell-based oncolytic virotherapy. Neural stem cells (NSCs) are used as tumor-tropic carriers to deliver a conditionally replicative adenovirus (CRAd-S-pk7) directly into the resection cavity via intracerebral catheter, with repeat dosing weekly or every 2 weeks. Mechanisms of action: (1) Targeted oncolysis—viral replication is driven by the survivin (BIRC5) promoter, active in high-grade glioma cells, (2) Enhanced infection—pk7 polylysine fiber modification enables CAR-independent entry via heparan sulfate proteoglycans, (3) Immune activation—tumor lysis may elicit anti-tumor T-cell responses. Cells/pathways targeted: glioblastoma/high-grade glioma cells with high survivin expression, HSPG-mediated viral entry, downstream induction of anti-tumor immunity with assessment of cytokines and T-cell exhaustion in CSF. Procedure includes surgical resection plus intracavitary dosing.