eligibility_summary
Age 1–31, high‑risk neuroblastoma with relapse/progression or refractory/persistent after ≥4 cycles. Disease must be documented by MIBG per rules or biopsy, or tumor in marrow. PS ≥50. Washouts: chemo 2w, biologic 7d, mAb 14d, cell 3w, RT 7d/12w, MIBG/HSCT 6w. Labs: ANC ≥750, PLT ≥75k (no tx), adequate renal/liver/cardiac, no active CNS. Exclusions include: pregnancy, major organ disease, infection, other cancer, prior allogeneic Tx/dialysis, recent steroids/immunosuppression.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase II single-arm chemoimmunotherapy for relapsed/refractory high‑risk neuroblastoma (“STING” acronym). Interventions: 1) Ex‑vivo expanded allogeneic Universal Donor TGFβ‑imprinted NK cells (cell therapy) engineered to resist TGF‑β–mediated suppression and enhance cytotoxicity/ADCC. 2) Dinutuximab (anti‑GD2 IgG1 monoclonal antibody) targeting GD2 on neuroblastoma to drive ADCC and complement killing. 3) Sargramostim/GM‑CSF (cytokine) activating myeloid effectors to augment ADCC. 4) Temozolomide (alkylating DNA‑methylating prodrug) inducing DNA damage. 5) Irinotecan (topoisomerase I inhibitor prodrug) causing replication‑associated DNA breaks. Targets/pathways: GD2+ neuroblastoma cells, NK cells and myeloid cells (neutrophils/macrophages), Fc‑mediated ADCC, overcoming TGF‑β immunosuppression, tumor DNA damage/repair pathways.