eligibility_summary
Include: ≥18, newly dx supratentorial GBM (WHO4, IDH‑WT, MGMT‑unmethylated) after SOC RT±TMZ + 2 adjuvant TMZ, residual non‑CE disease amenable to catheter, CE lesion ≤3 cm, KPS>70, MRI‑eligible, adequate labs, contraception. Exclude: pregnancy, herniation, serious comorbidity/infection/immunosuppression, non‑SOC therapy, RT/TMZ ≤11 wks, multifocal/midline/subependymal/leptomeningeal or infratentorial/spinal disease, >4 mg/d dex, steroid myopathy, active other cancer/autoimmune, MRI/contrast limits.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: 1) D2C7-IT (D2C7-(scdsFv)-PE38KDEL) is a recombinant immunotoxin: an EGFR/EGFRvIII-targeting antibody fragment fused to Pseudomonas exotoxin A. Delivered intracerebrally by convection-enhanced delivery, it binds EGFR/EGFRvIII on glioma cells, is internalized, and the PE toxin inactivates EF2 to block protein synthesis, causing tumor cell death. 2) 2141-V11 is an agonist anti-CD40 monoclonal antibody. It is infused once intratumorally and then given by repeated perilymphatic subcutaneous injections near cervical lymph nodes to activate CD40 on antigen-presenting cells, triggering NF-kB signaling, upregulating costimulatory molecules, cytokine production, and priming/expansion of tumor-specific T cells. Targets/pathways: EGFR/EGFRvIII-positive tumor cells, CD40 on dendritic cells/macrophages/B cells in cervical lymph nodes, downstream T-cell mediated antitumor immunity.