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    DRUG:

    Unituxin (dinutuximab)

    i
    Other names: Ch14.18, Ch 14.18UTC, MOAB Ch14.18, OP-08
    Company:
    Ohara Pharma, United Therapeutics Corporation
    Drug class:
    GD2 ganglioside inhibitor
    Related drugs:
    8d
    NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=42, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Sep 2026 --> Mar 2026
    Trial completion • Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
    2ms
    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
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • daretabart (hu1418K322A)
    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) | Initiation date: May 2026 --> Jul 2026
    Trial initiation date
    |
    cyclophosphamide • topotecan • Qarziba (dinutuximab beta) • iberdomide (CC-220) • Unituxin (dinutuximab) • Leukine (sargramostim)
    2ms
    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
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN expression
    |
    everolimus • Unituxin (dinutuximab) • tozasertib (MK-0457)
    3ms
    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
    |
    lenalidomide • Unituxin (dinutuximab)
    3ms
    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
    |
    lenalidomide • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    3ms
    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
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    3ms
    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
    |
    cyclophosphamide • topotecan • Qarziba (dinutuximab beta) • iberdomide (CC-220) • Unituxin (dinutuximab) • Leukine (sargramostim)
    4ms
    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
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    4ms
    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
    |
    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)
    |
    Unituxin (dinutuximab)
    4ms
    Immunotherapeutic advances in pediatric neuroblastoma: Overcoming resistance through biomarker-guided combinations. (PubMed, Biomed Pharmacother)
    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.
    Review • Journal • IO biomarker
    |
    ALK (Anaplastic lymphoma kinase) • CD276 (CD276 Molecule) • CSF2 (Colony stimulating factor 2) • L1CAM (L1 cell adhesion molecule)
    |
    ALK mutation
    |
    Unituxin (dinutuximab)
    4ms
    Rapid Administration Pilot for Infusing Dinutuximab (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, Children's Hospital Los Angeles | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    temozolomide • cyclophosphamide • irinotecan • topotecan • Unituxin (dinutuximab)