eligibility_summary
Eligible: adults (≥18) with confirmed R/M or unresectable HNSCC, RECIST-measurable disease, 1–2 prior systemic lines incl anti–PD-1/L1 (≥2 wks since last therapy), ECOG 0–1, adequate labs, baseline imaging, PD-L1 and HPV (if available), negative pregnancy test/contraception, consent. Exclude: ≥3 lines, RT <10 d, solid organ transplant, active CNS mets (treated/stable allowed), significant autoimmune on steroids, uncontrolled illness, active HBV/HCV, other active cancers, pregnancy/breastfeeding. HIV ok if VL undetectable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: 1) PD-L1 t-haNK: allogeneic NK-92–derived NK cell therapy engineered to recognize PD‑L1 and equipped with high‑affinity CD16 (FcγRIIIa) to enhance antibody‑dependent cellular cytotoxicity (ADCC), provides direct CAR‑NK killing of PD‑L1+ tumor cells and robust ADCC. 2) N‑803 (Anktiva): recombinant human IL‑15 superagonist cytokine complex, activates and expands NK and CD8+ T cells via IL‑15Rβ/γc signaling, improving effector function and persistence. 3) Cetuximab: anti‑EGFR IgG1 monoclonal antibody, blocks EGFR signaling and opsonizes tumor cells to trigger ADCC. Cells/pathways targeted: PD‑L1 on tumor cells, EGFR on HNSCC, IL‑15 receptor pathway in NK and CD8 T cells, FcγRIIIa‑mediated ADCC, infused NK‑92 effectors plus endogenous NK and CD8+ T cells.