eligibility_summary
Eligible: ≥12 months, high-risk neuroblastoma/ganglioneuroblastoma (refractory/relapsed/progressive or persistent after ≥4 cycles) or relapsed/refractory osteosarcoma, measurable disease, PS ≥50, recovered from prior therapy, adequate organ function (marrow/renal/liver/EF or FS, no dyspnea). Excluded: prior T‑cell therapy, pregnancy, active CNS disease, allo‑SCT, hemodialysis, active infection, HIV/HBV/HCV, prior dinutuximab intolerance, arrhythmias/myocarditis, live vaccine <30d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1 dose‑escalation testing a chemoimmunotherapy combo in relapsed/refractory neuroblastoma or osteosarcoma: 1) Allogeneic ex vivo expanded γδ T cells (adoptive cell therapy) — MHC‑independent cytotoxicity against stress‑ligand–expressing tumor cells, recognize phosphoantigens. 2) Dinutuximab (anti‑GD2 IgG1 monoclonal antibody) — binds GD2 on tumor cells to drive ADCC and complement‑mediated lysis. 3) Temozolomide (alkylating agent) — DNA O6‑methylation leading to tumor cell death. 4) Irinotecan (topoisomerase I inhibitor prodrug to SN‑38) — induces DNA breaks. 5) Zoledronic acid (nitrogen‑bisphosphonate) — inhibits farnesyl pyrophosphate synthase in the mevalonate pathway, increasing IPP to activate Vγ9Vδ2 γδ T cells, also anti‑osteoclast. Targets/pathways: GD2+ tumor cells, γδ T‑cell cytotoxicity, ADCC/complement, DNA damage pathways, and the mevalonate/IPP axis.