RecruitingNeuroblastoma
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Eligible age
1+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Sun Yat-Sen University Cancer Center
You may qualify if…
- ✓ 1)Confirmed diagnosis of high-risk NB 2)1 year of age or above 3)Patient or parent/guardian must provide written informed consent to participate 4)If patient is sexually active, the patient agrees to use effective contraception 5)Confirmed negative urine pregnancy test for sexually active female of child-bearing potential (post-menarche)
You may not qualify if…
- ✕ 1. Significant organ toxicity
- ✕ 2. Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components.
- ✕ 3. Patient is pregnant, planning to become pregnant (while being treated with naxitamab) or is currently breastfeeding
- ✕ 4. Patient will undergo treatment with another investigational drug, whilst being treated with naxitamab or has received another investigational drug within the 4 weeks prior to commencing treatment with naxitamab
- ✕ 5. Patient is either eligible and able to participate in or is currently participating in an active interventional Y-mAbs sponsored clinical trial with naxitamab within the indication applied for
- ✕ 6. Patient is unable to comply with the naxitamab treatment or has a medical condition that would potentially increase the severity of the toxicities experienced from naxitamab treatment at the discretion of the treating physician
- ✕ 7. Left ventricular ejection fraction of \<50% by echocardiography OR other clinically relevant cardiac disorders at the discretion of the investigator
- ✕ 8. Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry \< 94% and/or abnormal pulmonary function tests if these assessments are clinically indicated
Source: ClinicalTrials.gov · NCT06013618 · last updated 2025-06-17