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A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia

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Trial Profile

A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Jun 2022

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At a glance

  • Drugs Anti CD19 Chimeric Antigen Receptor T cell therapy Takara Bio (Primary) ; Cyclophosphamide
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms TBI-1501
  • Sponsors Otsuka Pharmaceutical; Takara Bio
  • Most Recent Events

    • 15 Jun 2022 Status changed from recruiting to active, no longer recruiting.
    • 09 Nov 2021 According to an Otsuka Pharmaceutical media release, under this termination, Takara Bio regains technical, intellectual property and other rights granted by Takara Bio to Otsuka. In addition, in the future Takara Bio will not receive lump-sum payments upon achievement of milestones under this agreement or receive any sales proceeds for clinical trial product sales.
    • 09 Nov 2021 According to an Otsuka Pharmaceutical media release, the company has decided jointly with Takara Bio Inc, to terminate agreements on co-development and exclusive marketing of CD19-targeted CAR gene therapies (TBI-1501). In consideration of the lengthy period for clinical development and the competitive landscape, the two companies have decided to terminate the agreement.

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