eligibility_summary
Inclusion: Adults with recurrent GBM after RT+temozolomide, MRI/biopsy‑confirmed progression, life ≥12 wk, KPS≥70/ECOG≤2, healed craniotomy. Phase 2B: first‑line only, IDH‑WT, TTFields ≥18 h/d. Exclusion: prior bevacizumab, high‑dose steroids, bleeding risk/anticoagulation, cardiac disease, autoimmune/IBD/transplant, uncontrolled seizures (2B), poor labs or ≤40 kg, pregnancy/nursing, recent surgery/experimental tx. 2B: prior TTFields/PD‑1, active implants, hydrogel allergy, brainstem‑adjacent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06061809 tests multi‑modal therapy for recurrent/progressive glioblastoma. Interventions/mechanisms: 1) N‑803 (nogapendekin alfa inbakicept, ALT‑803/Anktiva) — IL‑15 superagonist cytokine complex that expands/activates NK cells and CD8+ T cells (memory/effector) via IL‑15/IL‑15R signaling, enhancing cytotoxicity without expanding Tregs. 2) PD‑L1 t‑haNK — allogeneic NK cell therapy (engineered NK‑92) expressing a PD‑L1–targeting CAR and high‑affinity CD16 to kill PD‑L1+ tumor and immunosuppressive cells and mediate ADCC. 3) Bevacizumab — anti‑VEGF‑A monoclonal antibody that inhibits angiogenesis/endothelial proliferation and normalizes tumor vasculature. 4) Tumor Treating Fields (TTFields, 200 kHz device) — alternating electric fields that disrupt mitotic spindle/abscission in dividing tumor cells. Targets/pathways: IL‑15–driven NK/CD8 activation, PD‑L1 on GBM and myeloid cells, VEGF‑A/VEGFR angiogenic pathway, and tumor cell mitosis.