NCT07399821 An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
| NCT ID | NCT07399821 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Princess Maxima Center for Pediatric Oncology |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 22 participants in total. It began in 2025-11-05 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a non-randomized, open label phase Ib/II dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients. The aim of this imaging study is to determine a safe and effective dose of anti-GD2-800CW for intra-operative detection of neuroblastoma using NIR fluorescence.
Eligibility Criteria
Inclusion Criteria: * Patients with the diagnosis of neuroblastoma as defined by histopathology (confirmed by the PMC Department of Pathology), who will be operated for NB as standard of care procedure * Patients older than 1 year of age and not older than 18 years. * Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations Exclusion Criteria: * Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy * Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within during the screening period and before the administration of the IMP. * Breast feeding. * Sexually active participants not willing to use highly effective contraceptive method (pearl index \<1) as defined in CTFG HMA 2020 (Appendix I) during trial participation and until 6 months after end of protocol therapy. * Patients that received prior treatment with chimeric antibodies.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07399821 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07399821 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07399821 currently recruiting?
Yes, NCT07399821 is actively recruiting participants. Contact the research team at trialmanagement@prinsesmaximacentrum.nl for enrollment information.
Where is the NCT07399821 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT07399821 clinical trial?
NCT07399821 is sponsored by Princess Maxima Center for Pediatric Oncology. The trial plans to enroll 22 participants.