P1, N=13, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Sep 2025 --> Dec 2026 | Trial primary completion date: Sep 2025 --> Dec 2026

P1, N=27, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027

P3, N=1449, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed

P1/2, N=76, Not yet recruiting, National Cancer Institute (NCI)

P2, N=94, Active, not recruiting, Children's Oncology Group | Trial completion date: Apr 2026 --> Mar 2029

The GADEKILL γδ T and NK cells were analyzed by flow cytometry for the expression of activating and inhibitory receptors and for cytotoxicity against NB, both with and without dinutuximab-β, at a 1:1 effector-to-target ratio...Finally, NB cell lysis positively correlated with B7H6 and BTN2A1, and B7H6-blocking experiments revealed a significant decrease in target cell lysis when cells highly expressing B7H6 were used as targets. Our study demonstrated the potential antineuroblastoma activity of the GADEKILL, supporting its therapeutic use, particularly in the context of relapsed/refractory R/R HR-NB with low GD2 expression.

Naxitamb+GM-CSF is a good option to consolidate post-relapse CR of HR-NB. The encouraging long-term outcome cannot be attributed solely to naxitamab+GM-CSF given post-protocol therapies.

All sensitivity unadjusted and adjusted comparisons supported the results of the base-case analysis. Dinutuximab beta significantly prolonged OS compared to historical control cohorts not treated with dB in both unadjusted and adjusted indirect comparisons.

Recent advances in immunotherapy have reshaped the treatment landscape, with anti-GD2 monoclonal antibodies such as dinutuximab and naxitamab demonstrating significant clinical benefit, especially when combined with granulocyte-macrophage colony-stimulating factor (GM-CSF)...This review synthesizes current evidence on immunotherapeutic strategies in neuroblastoma, highlighting resistance pathways, biomarker-driven approaches, and the evolving clinical trial landscape. Future directions emphasize personalized, biomarker-guided immunotherapy to improve efficacy, reduce toxicity, and establish durable, curative outcomes for children with neuroblastoma.

P1, N=11, Active, not recruiting, Children's Hospital Los Angeles | Recruiting --> Active, not recruiting

P3, N=5, Recruiting, Federal Research Institute of Pediatric Hematology, Oncology and Immunology

For patients ≥547 days old, any age cut-off ≤40 months discriminated younger (superior EFS/OS) versus older patients; no cut-off was optimal. OCAYA diagnosed 2010-2022 (post-immunotherapy era) had superior outcomes versus 2003-2009. Stratification by comprehensive molecular biomarkers will likely best inform novel therapeutic strategies for OCAYA.