Actively Recruiting
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Led by Y-mAbs Therapeutics · Updated on 2026-02-19
122
Participants Needed
26
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 bone and/or bone marrow
- Life expectancy of at least 6 months
You will not qualify if you...
- Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before first dose of GM-CSF
- Neuroblastoma outside bone and bone marrow
- Major organ dysfunction greater than Grade 2 except hearing loss, hematological status, kidney and liver function
- Active life-threatening infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
University of Florida
Gainesville, Florida, United States, 32611
Withdrawn
2
University of Chicago
Chicago, Illinois, United States, 60637
Withdrawn
3
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
5
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Withdrawn
6
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Withdrawn
7
The Hospital for Sick Children
Toronto, Canada, M5G 1X8
Actively Recruiting
8
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
9
Hopital pour enfants de la Timone
Marseille, Marseille, France, 13005
Withdrawn
10
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
11
Johannes Gutenberg-Universität
Mainz, Germany
Actively Recruiting
12
University Hospital Regensburg
Regensburg, Germany
Actively Recruiting
13
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
14
Queen Mary Hospital
Hong Kong, Hong Kong
Active, Not Recruiting
15
Tata Memorial Centre
Mumbai, India, 400012
Actively Recruiting
16
Giannina Gaslini Hospital
Genoa, Genoa, Italy, 16147
Actively Recruiting
17
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milan, Italy, 20133
Actively Recruiting
18
Ospedale Pediatrico Bambino Gesù
Rome, Italy
Actively Recruiting
19
Hospital Sant Joan de Déu
Barcelona, Spain, 08950
Actively Recruiting
20
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Actively Recruiting
21
Hospital Universitario Virgen Del Rocío
Seville, Spain
Actively Recruiting
22
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
23
The Royal Glasgow Children's Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
24
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
25
The Royal Marsden
London, United Kingdom, SW3 6JJ
Withdrawn
26
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
R
Rhiannon Wright
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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