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An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases (EBVision)

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Trial Profile

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases (EBVision)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Tabelecleucel (Primary)
  • Indications Epstein-Barr virus infections; Haemophagocytic lymphohistiocytosis; Leiomyosarcoma; Lymphoproliferative disorders; Post-transplant lymphoproliferative disorder; Sarcoma
  • Focus Therapeutic Use
  • Acronyms EBVision
  • Sponsors Atara Biotherapeutics

Most Recent Events

  • 05 May 2025 Status changed from suspended to recruiting.
  • 05 May 2025 According to Atara Biotherapeutics media release, announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Ataras active Investigational New Drug (IND) applications for the EBVALLO (tabelecleucel) program, enabling resumption of clinical trials.
  • 07 Mar 2025 According to an Atara Biotherapeutics Media Release, company is currently undertaking efforts to support the third-party manufacturer in addressing the FDA's requests in order to lift the hold and support BLA resubmission; the Company anticipates providing a regulatory update in the second quarter of 2025.

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