Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Running, not enrolling · Phase 2

Conditions studied: Neuroblastoma

In brief

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Key facts

Study ID

NCT03363373

Run by

Y-mAbs Therapeutics

People needed

122

Starts

2018-04-03

Expected to finish

2028-04-01

Last updated by the study team

2026-07-30

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria
• High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow.
• Life expectancy ≥ 6 months

You may not qualify if…

• Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
• Evaluable neuroblastoma outside bone and bone marrow
• Existing major organ dysfunction > Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
• Active life-threatening infection

Where it is running

• Riley Hospital for Children — Indianapolis, Indiana, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The Hospital for Sick Children — Toronto, Canada
• Rigshospitalet — Copenhagen, Denmark
• University Medical Center Hamburg-Eppendorf — Hamburg, Germany
• Johannes Gutenberg-Universität — Mainz, Germany
• University Hospital Regensburg — Regensburg, Germany
• Hong Kong Children's Hospital — Hong Kong, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong
• Tata Memorial Centre — Mumbai, India
• Giannina Gaslini Hospital — Genoa, Genoa, Italy
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Milan, Italy
• Ospedale Pediatrico Bambino Gesù — Rome, Italy
• Hospital Sant Joan de Déu — Barcelona, Spain
• Hospital Infantil Universitario Niño Jesús — Madrid, Spain
• Hospital Universitario Virgen Del Rocío — Seville, Spain
• Hospital Universitario y Politécnico La Fe — Valencia, Spain
• The Royal Glasgow Children's Hospital — Glasgow, United Kingdom
• Leeds General Infirmary — Leeds, United Kingdom
• University Hospital Southampton — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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