OncoMatch/Clinical Trials/NCT07375563
Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma
Is NCT07375563 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Dinutuximab beta, temozolomide, irinotecan, autologous NK cell and irinotecan, temozolomide, dinutuximab beta, NK-cell product for neuroblastoma (nb).
Treatment: Dinutuximab beta, temozolomide, irinotecan, autologous NK cell · irinotecan, temozolomide, dinutuximab beta, NK-cell product — Neuroblastoma (NB) is a malignant neoplasm of the sympathetic nervous system, occurring in 1 in 8,000 live births, accounting for 6-10% of all childhood malignant neoplasms and responsible for 12-15% of mortality -, making it the most common and life-threatening extracranial tumor in childhood. Patients with stage 4 high-risk NB is the subgroup with the poorest prognosis. Within this group, two subgroups with an extremely unfavorable disease course are distinguished: patients with a poor response to the induction phase of therapy (refractory disease) and patients with relapsed or progressive disease. Nowadays, 10-15% of patients show a poor end-induction response, whereas achieving a good end-induction response associated with better long-term survival. Improvement of the response to induction therapy may contribute to better treatment outcomes in newly diagnosed high-risk NB patients and can be achieved by intensification of the induction phase to decrease the number of patients with refractory disease. Also intensification of the second-line therapy may contribute to better responses in patients with relapsed and progressive disease. Protocol aimed to overcome heterogeneous tumor drug resistance through the synergistic interaction of cytostatic and immunobiological agents in combination with NK cell therapy. This approach combines cytotoxic agents with anti-GD2 monoclonal antibodies (mAb) to enhance antitumor activity. Cultured, ex vivo-activated autologous NK cells are infused to compensate for effector cell depletion during therapy and to augment antibody-dependent cellular cytotoxicity (ADCC), potentially improving clinical outcomes. This comprehensive approach opens novel prospects for enhancing treatment efficacy in patients with refractory and relapsed high-risk NB. The expected outcomes of this protocol include a significant increase in therapeutic efficacy indicators - objective response rate (ORR), overall survival (OS), progression-free survival (PFS) and relapse-free survival (RFS), as well as in patient quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Disease stage
Required: Stage HIGH-RISK (GPOH-NB 2004)
Excluded: Stage LOW-RISK, INTERMEDIATE-RISK
Patients stratified to the high-risk group according to the criteria of the German Society of Pediatric Oncology and Hematology (GPOH) - NB 2004
Prior therapy
Must have received: induction chemotherapy — induction phase
patients who have completed the induction phase of therapy (6 cycles of N5/N6)
Lab requirements
Kidney function
creatinine clearance or GFR > 60 mL/min/1.73 m²
Liver function
ALT/AST activity < 5 × ULN
Cardiac function
No clinical signs of heart failure; LVEF ≥ 55%
Adequate liver function: alanine aminotransferase (ALT) / aspartate aminotransferase (AST) activity < 5 × upper limit of normal (ULN). Adequate renal function: creatinine clearance or glomerular filtration rate (GFR) > 60 mL/min/1.73 m². No clinical signs of heart failure; left ventricular ejection fraction (LVEF) ≥ 55%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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