Using dinutuximab beta with chemotherapy to treat high-risk neuroblastoma in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and initial efficacy of dinutuximab beta, an anti-GD2 antibody, in combination with various chemotherapy regimens for children with high-risk neuroblastoma that is refractory to standard treatments or has relapsed. The trial aims to recruit 20 patients aged 1-18 years who have not responded to first-line therapies. Participants will receive dinutuximab beta via continuous infusion for five days, alongside chemotherapy agents such as irinotecan, temozolomide, or topotecan. The study is designed to assess the potential for achieving a permanent remission in a population with limited treatment options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).
2. Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.
3. Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria).
4. Life expectancy ≥6 months.
5. Obtaining the informed written consent of the patient and/or statutory representative for the treatment.
6. Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding.
7. Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study.

Exclusion Criteria:

1. Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
2. Patients with neurological toxicities of ≥2 CTCAE WHO grade.
3. Active life-threatening infection until stabilization of the patient's condition.
4. Pregnancy and / or lactation.
5. Sexually active patients who refuse to use an effective method of contraception.
6. Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study.
7. Radiotherapy within 3 weeks prior to the start of the study.
8. Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL).
9. Lack of informed written consent to treatment.

Where it's running

• University Children Hospital
  Krakow, Malopolska, Poland Recruiting

Study contacts

• Principal investigator: Walentyna Balwierz, Prof. — Jagiellonian University
• Study coordinator: Walentyna Balwierz, Prof.
• Email: walentyna.balwierz@uj.edu.pl
• Phone: +48 12 333 92 20

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dinutuximab-beta with chemotherapy in newly diagnosed high-risk neuroblastoma

  This pilot study tests whether adding the antibody dinutuximab-beta to standard induction chemotherapy is safe and helps shrink tumors in kids and young adults with newly diagnosed high-risk neuroblastoma.

  Recruiting at 2 sites Phase 1 Chang Gung Memorial Hospital · Taipei, Taiwan and 1 other locations · NCT07688252

• hu14.18K322A with temozolomide and irinotecan for relapsed or refractory high‑risk neuroblastoma

  This trial will test whether the anti‑GD2 antibody hu14.18K322A given with temozolomide and irinotecan helps children and teens (18 months to 18 years) with relapsed or refractory high‑risk neuroblastoma.

  Recruiting at 20 sites Phase 2/3 Renaissance Pharma Ltd. · San Francisco, California and 19 other locations · NCT07549321

• Naxitamab added to standard induction therapy for newly diagnosed high-risk neuroblastoma

  This study tests whether adding Naxitamab and GM-CSF to the standard induction therapy improves outcomes for children and young people with newly diagnosed high-risk neuroblastoma.

  Recruiting Phase 2 Shaare Zedek Medical Center · Jerusalem · NCT07537400

• Dual-target GD2 and B7-H3 CAR-NK therapy for children and young adults with relapsed or refractory neuroblastoma

  This trial tries an off-the-shelf CAR-NK cell treatment that targets GD2 and B7-H3 for children and young adults whose high-risk neuroblastoma has returned or not responded to prior therapy.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07502287

• Iberdomide added to chemoimmunotherapy for relapsed or refractory neuroblastoma

  This study tests whether adding iberdomide to a chemoimmunotherapy regimen helps children and young people with relapsed, refractory, or progressing neuroblastoma.

  Recruiting at 4 sites Phase 1/2 National Cancer Institute (NCI) · Oakland, California and 3 other locations · NCT07437963

• Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for relapsed or refractory neuroblastoma in children

  This trial tests a four-drug combination to see if it can control neuroblastoma in children whose disease has come back or not responded to treatment.

  Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07318831

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.