A pivotal phase III trial to investigate the efficacy and safety of Epstein Barr virus specific T-cell therapy (EBV-CTL) for the treatment of patients with EBV Post-Transplant Lymphoproliferative Disorder (EBV-PTLD) following solid organ transplant (SOT)

Trial Profile

A pivotal phase III trial to investigate the efficacy and safety of Epstein Barr virus specific T-cell therapy (EBV-CTL) for the treatment of patients with EBV Post-Transplant Lymphoproliferative Disorder (EBV-PTLD) following solid organ transplant (SOT)

Planning
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2017

At a glance

  • Drugs Epstein-Barr virus-specific T-cell therapy Atara/MSKCC (Primary)
  • Indications Lymphoproliferative disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms ALLELE
  • Sponsors Atara Biotherapeutics
  • Most Recent Events

    • 20 Apr 2017 Planned initiation date changed from 1 Oct 2016 to 1 Jul 2017, according to an Atara Biotherapeutics media release.
    • 20 Apr 2017 According to an Atara Biotherapeutics media release, the Company expects to initiate this trial in the second half of the year 2017.
    • 03 Jan 2017 According to an Atara Biotherapeutics media release, the Company plans to submit in 2018 an application for Conditional Marketing Authorization Approval of ATA 129 in the treatment of patients with rituximab refractory EBV-PTLD following hematopoietic cell transplant (HCT). The Conditional MAA will be based on data from phase I and II studies and supported by available data from the pase III studies in rituximab refractory EBV-PTLD after HCT and solid organ transplantation (SOT).
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