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    DRUG CLASS:

    GD2 ganglioside inhibitor

    Related drugs:
    5d
    Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5 (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Shaare Zedek Medical Center
    New P2 trial
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    ALK (Anaplastic lymphoma kinase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CSF2 (Colony stimulating factor 2)
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    ALK mutation • MYCN amplification
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    Danyelza (naxitamab-gqgk)
    6d
    Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
    P2, N=153, Completed, St. Jude Children's Research Hospital | Active, not recruiting --> Completed
    Trial completion
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    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
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    MYCN amplification
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    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • daretabart (hu1418K322A)
    7d
    Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (clinicaltrials.gov)
    P1/2, N=76, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: May 2026 --> Jul 2026
    Trial initiation date
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    cyclophosphamide • topotecan • Qarziba (dinutuximab beta) • iberdomide (CC-220) • Unituxin (dinutuximab) • Leukine (sargramostim)
    14d
    Concurrent naxitamab and lorlatinib in a patient with refractory high-risk neuroblastoma: a case report. (PubMed, Front Oncol)
    Mild adverse events occurred during the combined immunotherapy, including transient hypotension managed with intravenous fluids and abdominal and leg pain that improved with analgesics. In conclusion, our case showed that combination therapy with naxitamab and lorlatinib may improve long-term outcomes and reduce chemotherapy-related toxicity.
    Journal • IO biomarker
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    ALK (Anaplastic lymphoma kinase)
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    ALK mutation
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    oncoReveal™ Multi-Cancer with CNV & RNA Fusion Panel
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    Lorbrena (lorlatinib) • Danyelza (naxitamab-gqgk)
    20d
    Role of Anti-GD2 Targeted PEG-b-PLGA Nanoparticles in the Treatment of MYCN Driven Neuroblastoma. (PubMed, ACS Appl Bio Mater)
    Everolimus (EVER) and tozasertib (TOZA) encapsulated in NP and targeted with dinutuximab β (DTX-β). DTX-β/EVER-TOZA@PEG-b-PLGA may exert cytotoxic and apoptotic effects in NB. The use of targeted nanocarriers in NB treatment may enhance cytotoxic and apoptotic responses specifically in the tumor region.
    Journal
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    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
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    MYCN expression
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    everolimus • Unituxin (dinutuximab) • tozasertib (MK-0457)
    26d
    End-of-Induction Response and Tolerability of High-Risk Neuroblastoma Treated with Chemoimmunotherapy-Modified N7 Regimen with Dinutuximab Beta. (PubMed, Cancers (Basel))
    The incorporation of dinutuximab beta into a modified N7 induction regimen demonstrates a satisfactory EOI response rate and a manageable safety profile in children with HR-NB. These preliminary results support the feasibility of this chemoimmunotherapy approach and warrant further investigation in larger cohorts to confirm its efficacy in long-term survival outcomes.
    Journal
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    CSF2 (Colony stimulating factor 2)
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    Qarziba (dinutuximab beta)
    1m
    NANT 2013-01: Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (clinicaltrials.gov)
    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
    Trial completion date • Trial primary completion date
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    lenalidomide • Unituxin (dinutuximab)
    2ms
    NANT: Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (clinicaltrials.gov)
    P1, N=27, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date
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    lenalidomide • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    2ms
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
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    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    2ms
    Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (clinicaltrials.gov)
    P1/2, N=76, Not yet recruiting, National Cancer Institute (NCI)
    New P1/2 trial
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    cyclophosphamide • topotecan • Qarziba (dinutuximab beta) • iberdomide (CC-220) • Unituxin (dinutuximab) • Leukine (sargramostim)
    2ms
    Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
    P2, N=94, Active, not recruiting, Children's Oncology Group | Trial completion date: Apr 2026 --> Mar 2029
    Trial completion date
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    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    2ms
    The gamma delta T/NK cell product GADEKILL as a novel immunotherapeutic tool for neuroblastoma patients: role of B7H6 and BTN2A1 in tumor cell killing. (PubMed, Front Immunol)
    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.
    Journal • IO biomarker
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    LAMP1 (Lysosomal Associated Membrane Protein 1) • BTN2A1 (Butyrophilin Subfamily 2 Member A1) • CALR (Calreticulin) • BTN3A1 (Butyrophilin Subfamily 3 Member A1) • NKG2D (killer cell lectin like receptor K1)
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    Unituxin (dinutuximab)