An experimental trial to learn about hu14.18K322A treatment in children and adolescents with high-risk neuroblastoma.

You may be able to join if

• 1. ≥18 months to <18 years 2. Initially diagnosed with histologically proven HRNB with metastatic disease 3. Have evaluable or measurable disease per INRC, (Park, 2017) 4. Have a Lansky performance status of ≥50 or Karnofsky performance status ≥50% 5. Have recovered from the toxic effects of prior chemotherapies as per institutional guidelines 6. Are at least 2 weeks beyond any major tumor surgery and fully recovered from any post-surgical complications 7. Meet the following organ function criteria, as measured within 1 week prior to IMP dosing: a. BM function: i. Platelets ≥50 × 109/L ii. Absolute neutrophil count (ANC) ≥0.50 × 109/L b. Renal function: i. Age-adjusted serum creatinine ≤1.5 × ULN for age ii. eGFR at least 60 mL/min using the Schwartz formula c. Liver function: AST or ALT ≤3 × ULN and total bilirubin ≤1.5 × ULN. In case of liver metastases, AST or ALT ≤5 × ULN and total bilirubin ≤1.5 × ULN d. Cardiac function: i. Shortening fraction ≥27% or ejection fraction of ≥50% on echocardiogram ii. QTc on ECG using QTcF ≤ 450 msec e. Lung function: i. Pulse oximetry considered normal in room air, per Investigator judgment. No evidence of dyspnea at rest. f. CNS function: i. No clinical or radiological evidence of active CNS disease at the time of study enrollment ii. Participants with seizure disorders may be enrolled if seizures are well controlled on anti-seizure medications iii. No active CNS toxicity 8. Consent to pregnancy testing and use of an acceptable contraception method if applicable 9. If a fertile and sexually active male, agree to use condoms 10. Are willing and able to provide voluntary written informed assent 11. Parent or legal guardian is willing and able to provide and has provided voluntary written informed consent Sub Protocol A: a. Patients experiencing their first or second relapse having achieved disease stabilization or an initial response (SD, MR, PR or CR) to previous therapy b. If received prior anti-GD2 therapy, last dose administered at least 14 days previously and no ongoing toxicities c. If applicable, at least 6 weeks from AHCT following myeloablative therapy Sub Protocol B: a. HRNB participants who are first line refractory following a minimum of 4 cycles of induction chemotherapy with no history of PD, where refractory is defined as SD, MR or PR with at least one metastatic lesion remaining b. Identification of primary tumor documented c. Measurable disease by cross sectional imaging INRC, (Park, 2017).