Actively Recruiting
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Led by Sun Yat-Sen University Cancer Center · Updated on 2025-06-17
120
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen University Cancer Center
Lead Sponsor
H
Hainan General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an prospective study to evaluate the safety and efficacy of naxitamab monotherapy or combined with chemotherapy or combined with chemotherapy and checkpoint inhibitor in the treatment of pediatric high-risk and refractory/relapsed neuroblastoma in Sun Yat-sen University Cancer Center.
CONDITIONS
Official Title
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of high-risk neuroblastoma
- Age 1 year or older
- Patient or parent/guardian provides written informed consent
- If sexually active, agrees to use effective contraception
- Negative urine pregnancy test for sexually active females of child-bearing potential (post-menarche)
You will not qualify if you...
- Significant organ toxicity
- Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or GM-CSF
- Currently pregnant, planning pregnancy during naxitamab treatment, or breastfeeding
- Receiving another investigational drug during naxitamab treatment or within 4 weeks prior
- Participation in another active Y-mAbs clinical trial with naxitamab for the same indication
- Unable to comply with naxitamab treatment or has medical condition increasing risk of treatment toxicity
- Left ventricular ejection fraction below 50% or other significant cardiac disorders
- Inadequate pulmonary function with symptoms or abnormal tests
- For naxitamab plus GM-CSF treatment only: active progression of neuroblastoma
- Active neuroblastoma at primary site or soft-tissue metastasis
- Known central nervous system metastases at start of naxitamab treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang, MD
CONTACT
J
Juan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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