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Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Sponsor: Y-mAbs Therapeutics
Summary
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
Official title: A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Key Details
Gender
All
Age Range
1 Year - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2018-04-03
Completion Date
2028-04
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
GM-CSF + Naxitamab
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody
Locations (26)
University of Florida
Gainesville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
The Hospital for Sick Children
Toronto, Canada
Rigshospitalet
Copenhagen, Denmark
Hopital pour enfants de la Timone
Marseille, Marseille, France
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
The Royal Marsden
London, United Kingdom
University Hospital Southampton
Southampton, United Kingdom