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    DRUG:

    daretabart (hu1418K322A)

    i
    Other names: hu1418K322A, Hu14.18K322A, Hu14.18
    Associations

    News

    Trials
    Company:
    Essential Pharma, Renaissance Pharma, St. Jude Children's Research Hospital
    Drug class:
    GD2 ganglioside inhibitor
    Related drugs:
    Associations

    News

    Trials
    18d
    SHINE: A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients (clinicaltrials.gov)
    P2/3, N=144, Recruiting, Renaissance Pharma Ltd.
    New P2/3 trial
    |
    temozolomide • irinotecan • daretabart (hu1418K322A)
    26d
    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)
    7ms
    A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
    P2, N=54, Recruiting, St. Jude Children's Research Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CSF2 (Colony stimulating factor 2)
    |
    temozolomide • irinotecan • Anktiva (nogapendekin alfa inbakicept-pmln) • Leukine (sargramostim) • daretabart (hu1418K322A)
    9ms
    A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, St. Jude Children's Research Hospital | Initiation date: Jul 2025 --> Dec 2025
    Trial initiation date
    |
    CSF2 (Colony stimulating factor 2)
    |
    temozolomide • irinotecan • Anktiva (nogapendekin alfa inbakicept-pmln) • Leukine (sargramostim) • daretabart (hu1418K322A)
    10ms
    A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, St. Jude Children's Research Hospital
    New P2 trial
    |
    CSF2 (Colony stimulating factor 2)
    |
    temozolomide • irinotecan • Anktiva (nogapendekin alfa inbakicept-pmln) • Leukine (sargramostim) • daretabart (hu1418K322A)
    1year
    Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
    P2, N=153, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • daretabart (hu1418K322A)
    over2years
    Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
    P2, N=153, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    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)
    3years
    KIR/KIR-ligand genotypes and clinical outcomes following chemoimmunotherapy in patients with relapsed or refractory neuroblastoma: a report from the Children's Oncology Group. (PubMed, J Immunother Cancer)
    These findings are consistent with those of prior studies showing that KIR/KIR-ligand genotypes are associated with clinical outcomes following anti-GD2 immunotherapy in children with neuroblastoma. The current study confirms the importance of KIR/KIR-ligand genotype in the context of I/T/DIN/GM-CSF chemoimmunotherapy administered to patients with relapsed or refractory disease in a clinical trial. These results are important because this regimen is now widely used for treatment of patients at time of first relapse/first declaration of refractory disease. Efforts to assess the role of NK cells and genes that influence their function in response to immunotherapy are ongoing.
    Clinical data • Journal • IO biomarker
    |
    NCAM1 (Neural cell adhesion molecule 1) • CSF2 (Colony stimulating factor 2) • KLRB1 (Killer Cell Lectin Like Receptor B1)
    |
    temozolomide • irinotecan • temsirolimus • Unituxin (dinutuximab) • daretabart (hu1418K322A)
    4years
    Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. (PubMed, J Clin Oncol)
    Adding hu14.18K322A to induction chemotherapy improved early objective responses, significantly reduced tumor volumes in most patients, improved end-of-induction response rates, and yielded an encouraging 3-year EFS. These results, if validated in a larger study, may be practice changing.
    Clinical • P2 data • Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    melphalan • busulfan • daretabart (hu1418K322A)
    over4years
    Global Neuroblastoma Network: An international multidisciplinary neuroblastoma tumor board for resource-limited countries. (PubMed, Pediatr Blood Cancer)
    This report shows the utility of an international tumor board for LMIC focused on a challenging solid tumor where local expertise may be limited, with international multidisciplinary expert participation and educational sessions.
    Journal
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    daretabart (hu1418K322A)
    5years
    Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
    P2, N=153, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Jul 2021 --> Dec 2023 | Trial primary completion date: Jan 2021 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2)
    |
    MYCN amplification
    |
    cisplatin • doxorubicin hydrochloride • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • cyclophosphamide intravenous • daretabart (hu1418K322A)