eligibility_summary
Key eligibility: NB at diagnosis (histology or BM+catecholamines), high-risk (MYCN-amplified stage L2/M/MS any age or MYCN-nonamplified stage M ≥18 mo), completed frontline therapy with CR (BM MRD allowed) ±ASCT, age ≥12 mo, life exp >6 mo, consent. Exclude: PD, recent therapy/ASCT/131I-MIBG, prior anti-GD2, PS<50%, cardiac/pulmonary issues, infections, growth factors/immunosuppression, allergies, CNS NB, seizures, poor labs, eGFR<60, noncompliance, pregnancy/inadequate contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT06047535: Single-arm, phase 4 maintenance trial in high-risk neuroblastoma in first complete response. Interventions: (1) Naxitamab—type: humanized anti-GD2 monoclonal antibody, MOA: binds GD2 on neuroblastoma cells to trigger immune killing via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). (2) GM-CSF (sargramostim)—type: cytokine/myeloid growth factor, MOA: expands and activates granulocytes and monocytes/macrophages via CSF2 receptor, enhancing Fcγ receptor–mediated ADCC/phagocytosis against GD2-bound tumor cells. (3) Isotretinoin (13-cis-retinoic acid)—type: oral retinoid, MOA: activates RAR/RXR signaling to induce differentiation and apoptosis of residual neuroblastoma cells. Targets/pathways: GD2 on neuroblastoma, myeloid effector cells (neutrophils, monocytes/macrophages), Fc-mediated cytotoxicity, GM-CSF–driven myelopoiesis, retinoid receptor transcriptional programs.