eligibility_summary
Eligibility: Consent, age 1–<25, histologic high‑grade osteosarcoma in 1st/2nd relapse with CR or focal PR after ≥2nd‑line therapy (≤2 unilateral lung nodules), KPS/Lansky ≥60, life ≥3 mo, non‑heme tox <G2, adequate marrow/organ, LVEF>50%, tumor tissue available. Exclude: other recent cancer, active HBV/HCV/HIV, progression/multifocal disease, prior anti‑GD2, recent surgery/RT/chemo/immuno/investigational drug/live vaccine, steroids near tx, neuropathy/photophobia ≥G2, uncontrolled illness/seizures, pregnant/lactating, contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Dinutuximab beta (Qarziba), a chimeric IgG1 anti-GD2 monoclonal antibody immunotherapy. Dosing: continuous IV 14 mg/m2/day on days 1–5 every 28 days for 5 cycles as maintenance after response in relapsed/refractory high‑grade osteosarcoma. Mechanism of action: binds the disialoganglioside GD2 on tumor cells and triggers immune effector killing via Fc-mediated antibody‑dependent cell‑mediated cytotoxicity (ADCC) and phagocytosis, and complement‑dependent cytotoxicity (CDC). Targets: GD2-expressing osteosarcoma cells, engages innate immune effectors (NK cells, macrophages, neutrophils) through Fcγ receptors and activates the complement cascade. No IL‑2 or GM‑CSF co-therapy planned. Trial: Phase II, single-arm, status suspended (study not started).