A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients (NCT07549321) | Clinical Trial Compass
RecruitingPhase 2/3
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
United States144 participantsStarted 2026-03-30
Plain-language summary
Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years. Most patients have 'high-risk' disease, with spread of the disease to different sites (metastases). This multinational study aims to find out how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A (daretabart) is when used together with chemotherapy to treat children and young people who have high-risk neuroblastoma.
Who can participate
Age range
18 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Are ≥18 months to \<18 years of age at time of informed consent or assent.
. Are initially diagnosed with histologically proven HRNB with metastatic disease.
. Have evaluable or measurable disease per International Neuroblastoma Response Criteria (INRC)
. Have a Lansky performance status of ≥50 (≤16 years ) or Karnofsky performance status ≥50% (for \>16 years).
. Have recovered from the toxic effects of prior chemotherapies
. Are at least 2 weeks beyond any major tumor surgery
. Meet the following organ function criteria, as measured within 1 week prior to Investigational Medicinal Product (IMP) dosing:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate (ORR)
Timeframe: Assessed at end of treatment (up to 12 months)
2
Metastatic complete response rate (mCRR)
Timeframe: Assessed at end of treatment (up to 12 months)
. BM function: i. Platelets ≥50 × 109/L ii. Absolute neutrophil count (ANC) ≥0.50 × 109/L
Exclusion criteria
. Any active uncontrolled infection at the time of enrollment. Any known history of infection with human immunodeficiency virus (HIV), or active or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
. Any contraindications to any of the study treatments.
. Patients with \>Grade 2 diarrhea.
. Patients with disease of any major organ system that would compromise their ability to withstand chemoimmunotherapy.
. Patients who have undergone a prior allogeneic stem cell transplant \< 6 months ago or have undergone a solid organ transplant.
. Patients who are on hemodialysis.
. Patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study except to manage allergic reactions
. Patients on any other immunosuppressive medications