NCT05272371 Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease
| NCT ID | NCT05272371 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jagiellonian University |
| Condition | High-Risk Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-09-30 |
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 20 participants in total. It began in 2021-12-01 with a primary completion date of 2026-09-30.
⚠ 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
Safety evaluation and initial efficacy evaluation will be conducted in a group of patients as a non-commercial, open-label clinical trial of dinutuximab beta (Qarziba) phase IIa. The investigational medicinal product will be dinutuximab beta (anti-GD2 antibodies against GD2 disialoganglioside on NBL cells) at a dose of 10 mg / m2 / day by continuous infusion for 5 days in combination with irinotecan / temozolomide, topotecan / temozolomide or N5 / N6 chemotherapy GPOH protocol. The study group will be patients with recurrent / progression of NBL or disease resistant to first-line treatment, for whom there are currently no standards of management, and the treatment methods used so far do not give a chance to achieve a permanent remission of the disease. After diagnosis of relapse / progression or resistance to treatment, it is permissible to administer 2 cycles of standard chemotherapy prior to enrollment in the study. The study plans to recruit 20 patients who will receive 5-7 cycles of DB with chemotherapy. The choice of an appropriate chemotherapy regimen will depend on the patient's prior treatment and tolerance. The safety assessment will be conducted based on the registration of the types and frequency of adverse reactions identified on the basis of the registration of clinical parameters, symptoms and / or diseases reported by the patient or identified during the intervention and / or follow-up visits, abnormal laboratory and / or imaging test results. The initial assessment of the effectiveness will consist in comparing the percentage of objective responses obtained and the annual EFS and PFS (imaging tests, including scintigraphy, bone marrow examination and tumor markers). The study also included an exploratory evaluation of the usefulness of immunological, genetic and other studies.
Eligibility Criteria
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.
Contact & Investigator
Walentyna Balwierz, Prof.
PRINCIPAL INVESTIGATOR
Jagiellonian University
Frequently Asked Questions
Who can join the NCT05272371 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying High-Risk 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 NCT05272371 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 NCT05272371 currently recruiting?
Yes, NCT05272371 is actively recruiting participants. Contact the research team at walentyna.balwierz@uj.edu.pl for enrollment information.
Where is the NCT05272371 trial being conducted?
This trial is being conducted at Krakow, Poland.
Who is sponsoring the NCT05272371 clinical trial?
NCT05272371 is sponsored by Jagiellonian University. The principal investigator is Walentyna Balwierz, Prof. at Jagiellonian University. The trial plans to enroll 20 participants.