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Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

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Trial Profile

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2024

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At a glance

  • Drugs Tabelecleucel (Primary)
  • Indications Diffuse large B cell lymphoma; Lymphoproliferative disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms ALLELE
  • Sponsors Atara Biotherapeutics

    • Most Recent Events

    • 28 Mar 2024 According to an Atara Biotherapeutics media release, company expects to receive $20 million of regulatory milestones in Apr. based on the recent positive preBLA meeting, another $20 million in connection with BLA acceptance, and the remaining $60 million in potential regulatory milestones in connection with BLA approval. Pierre Fabre Laboratories will reimburse Atara for Ebvallo regulatory and development costs through BLA approval, and purchase drug inventory manufactured through BLA transfer.
    • 28 Mar 2024 According to an Atara Biotherapeutics media release, company ecently held a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) that supports its plan to submit the tab-cel relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) Biologics License Application (BLA) in Q2 2024.
    • 31 Jan 2024 Results published in an Atara Biotherapeutics media release.
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