eligibility_summary
Eligible: Newly diagnosed INSS neuroblastoma, age ≤21 at diagnosis and >12 months at enrollment. Stage 4: >18 mo, or 12–18 mo with unfavorable biology (e.g., MYCN amp, poor histology, DNA index=1), or any age with MYCN amp. Stage 3: MYCN amp, or >18 mo with poor histology. Stage 2A/2B: MYCN amp. Exclude: <1 y, Stage 3 with favorable biology, recent immunosuppression, investigational drugs, major comorbidities/conditions impeding participation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial NCT06574698 tests adding naxitamab (DANYELZA), an anti-GD2 IgG1 monoclonal antibody immunotherapy, during induction chemotherapy for newly diagnosed high‑risk neuroblastoma. Mechanism: naxitamab binds the disialoganglioside GD2 on neuroblastoma cells and mediates immune effector killing via Fc-dependent antibody‑dependent cellular cytotoxicity (ADCC) by NK cells, antibody‑dependent cellular phagocytosis (ADCP) by macrophages, and complement‑dependent cytotoxicity (CDC). Target cells/pathways: GD2-positive neuroblastoma cells, engagement of Fcγ receptors on NK cells/macrophages and activation of the complement cascade. Study aim: improve end‑of‑induction response and overall survival in pediatric/AYA high‑risk patients in a prospective single‑arm setting.