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A Study to Evaluate Tabelecleucel in Participants With Epstein-barr Virus-associated Diseases

Testing Tabelecleucel for Epstein-Barr Virus-related conditions.

Recruiting
All
Phase 2

This study looks at how safe and effective a treatment called tabelecleucel is for people with diseases linked to the Epstein-Barr virus (EBV). EBV is a virus that can cause certain diseases. Tabelecleucel is a special type of cell treatment. The study is open-label, meaning all participants know they are getting the treatment. Participants will be grouped based on their specific EBV disease type.

Tabelecleucel is given through a vein (IV) once a week for three weeks in each cycle, which lasts 35 days. The treatment continues until the best possible response is achieved or if the disease worsens. There are safety checks 30 days after the last dose and follow-ups every three months for up to two years.

  • The study lasts up to two years, with regular follow-ups.
  • Participants are given tabelecleucel IV weekly for three weeks in 35-day cycles.
  • Participants must have an EBV-related disease and meet specific health criteria.

Participants must not have certain other diseases or be pregnant. They should also be willing to follow specific medical guidelines during the study.

Study details
    Epstein-Barr Virus (EBV)-Associated Diseases
    EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
    EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD)
    EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
    EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
    Solid Organ Transplant Complications
    Lymphoproliferative Disorders
    Allogeneic Hematopoietic Cell Transplant
    Stem Cell Transplant Complications
    EBV+ Sarcomas
    Leiomyosarcoma

NCT04554914

Atara Biotherapeutics

16 February 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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