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Long-term continuous infusion of anti-GD2 antibody CH14.18/CHO in relapsed/refractory High-Risk neuroblastoma patients.

Trial Profile

Long-term continuous infusion of anti-GD2 antibody CH14.18/CHO in relapsed/refractory High-Risk neuroblastoma patients.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Dinutuximab beta (Primary) ; Aldesleukin; Isotretinoin
  • Indications Neuroblastoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Apeiron Biologics
  • Most Recent Events

    • 28 Jul 2023 According to a Recordati media release, to obtain FDA approval of a Biologics License Application (BLA) for the registration of Qarziba in the United States, preparatory activities are ongoing for a Type C Meeting with the FDA, expected in second half of 2023.
    • 05 Jun 2018 Results assessing a correlation between lymphocyte subsets, functional immune-parameters and survival in patients treated with ch14.18/CHO combined with interleukin-2 , presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
    • 18 Dec 2017 According to an APEIRON Biologics media release, results of this study were a key component of Marketing Authorisation Application for dinutuximab beta to the European Medicines Agency granted in May, 2017. Data will be used for Biologics Licence Application (BLA) to the FDA in the U.S. which is expected during 2018.
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