eligibility_summary
Eligible: adults (≥18) with recurrent supratentorial GBM (WHO 4), biopsy-proven, KPS ≥70, adequate labs/organ function, MRI-capable, prior polio series plus IPOL boost 1–6 wks pre-infusion, consent. Exclude: pregnancy, herniation risk, serious infection/immunodeficiency, severe comorbidity, albumin allergy or agammaglobulinemia, recent anti-cancer therapy, brainstem/cerebellar/spinal or leptomeningeal disease, high-dose steroids/steroid myopathy, active malignancy, recent systemic autoimmune therapy, lomustine/dacarbazine allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Randomized Phase 2 in recurrent supratentorial GBM comparing lerapolturev (PVSRIPO) vs lomustine after maximal safe resection. Interventions/mechanisms: • Lerapolturev (type: oncolytic immunotherapy, live-attenuated poliovirus type 1 Sabin/rhinovirus chimera). Mechanism: binds poliovirus receptor CD155/Necl-5 highly expressed on GBM cells and antigen-presenting cells, replicates in tumor causing oncolysis and antigen release, triggers innate antiviral/type I IFN signaling and dendritic-cell activation, driving tumor-specific T-cell responses. Delivery: intratumoral CED x2 (4 days apart), then perilymphatic subcutaneous injections near cervical lymph nodes to boost nodal immunity. • Lomustine (type: nitrosourea alkylating chemotherapy). Mechanism: DNA alkylation/crosslinking → cytotoxicity. Targets/cellular pathways: GBM cells expressing CD155, tumor-resident APCs and cervical lymph-node dendritic cells/macrophages, innate antiviral (RIG-I/MDA5–IFN) and adaptive T-cell responses, DNA replication/repair pathways (lomustine).