eligibility_summary
Inclusion: confirmed high‑risk neuroblastoma, age ≥1, consent, contraception if sexually active, negative urine pregnancy test for post‑menarche sexually active females. Exclusion: significant organ toxicity, allergy to anti‑GD2/GM‑CSF, pregnant/breastfeeding, recent/concurrent investigational drug, eligible for/in active Y‑mAbs naxitamab trial, noncompliance/unsafe, LVEF <50%/cardiac disease, poor lung function (SpO2<94%). With GM‑CSF: active progression, primary/soft‑tissue disease, or CNS mets.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 2, single-center trial testing: 1) Naxitamab (hu3F8) ± GM-CSF: Naxitamab is a humanized IgG1 anti-GD2 monoclonal antibody that binds GD2 on neuroblastoma cells, triggering Fcγ receptor–mediated ADCC and complement-dependent cytotoxicity, GM-CSF (recombinant cytokine) expands/activates granulocytes/monocytes/macrophages to enhance ADCC. 2) Naxitamab + GM-CSF + irinotecan/temozolomide: Irinotecan (topoisomerase I inhibitor) and temozolomide (DNA-alkylating agent) induce DNA damage in proliferating tumor cells. 3) The above plus sintilimab: Sintilimab is an anti–PD-1 monoclonal antibody that blocks PD-1/PD-L1 signaling to restore T-cell activity. Targets/pathways: GD2 on neuroblastoma cells, Fc-mediated ADCC/complement, myeloid activation, DNA replication/repair (Topo I, alkylation), PD-1 immune checkpoint on T cells.