Study on Tabelecleucel for Treating Epstein-Barr Virus-Associated Diseases

Sponsor: Atara Biotherapeutics

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04554914

Provider View

This clinical trial is testing the effectiveness and safety of a treatment called tabelecleucel for people with diseases linked to the Epstein-Barr virus (EBV).

Patient Parameters

Program Overview

The study aims to find out how well tabelecleucel works and how safe it is for treating diseases associated with the Epstein-Barr virus (EBV). Participants will be grouped based on their specific EBV-related condition, such as certain types of lymphoproliferative diseases (LPD) or sarcomas. The treatment involves receiving tabelecleucel through an IV over a 35-day cycle, with regular monitoring to assess the response and any side effects. The study will continue until the disease progresses, the treatment is no longer tolerated, or other treatments are started. Participants will have follow-up visits to monitor their health and the disease's status.

Description

This study is testing a treatment called tabelecleucel for people with diseases linked to the Epstein-Barr virus (EBV). It's a Phase 2 study, meaning it's focused on understanding how well the treatment works and its safety. Participants will be divided into groups based on their specific EBV-related condition, such as certain types of lymphoproliferative diseases (LPD) or sarcomas.

Tabelecleucel will be given in cycles lasting 35 days. During each cycle, participants will receive the treatment through an IV once a week for three weeks, followed by a period of observation. The treatment will continue until the disease progresses, the treatment is no longer tolerated, or other treatments are started. For those with EBV+ sarcoma, the treatment may continue for up to 12 months or until two complete responses are achieved.

After finishing the treatment, participants will have a follow-up visit 30 days later and then every three months to check on their health and the disease's status. The study will use an adaptive design, meaning the number of participants in each group may change based on early results. The study will continue until 24 months after the first dose for each participant.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with an EBV+ disorder.
  • Good overall health, with a performance status score of 3 or less for those aged 16 and older, or a Lansky score of 20 or more for those aged 1 to 15.
  • Adequate organ function unless the organ issues are due to the EBV-related disease.

Cohort-specific Inclusion Criteria:

  • For those with PID LPD:

    • Disease that has returned or is newly diagnosed and not suitable for standard treatment.
    • Confirmed EBV+ LPD through biopsy or positive cerebrospinal fluid (CSF) test.
    • May have disease in the body, brain, or both.

  • For those with AID LPD:

    • Disease that has returned or is newly diagnosed and not suitable for standard treatment.
    • Confirmed EBV+ LPD through biopsy or positive CSF test.
    • May have disease in the body, brain, or both.

  • For those with CNS PTLD:

    • Disease that has returned or is newly diagnosed and not suitable for standard treatment.
    • Confirmed EBV+ CNS PTLD through biopsy or positive CSF test.
    • May have disease in the brain or both body and brain.

  • For those with EBV+ PTLD:

    • Confirmed EBV+ PTLD not suitable for standard treatment.
    • Must have measurable disease.

  • For those with sarcoma or smooth muscle tumors:

    • Rapidly progressing EBV+ sarcoma or smooth muscle tumor not suitable for standard treatment.
    • Confirmed EBV+ sarcoma through biopsy.
    • Must have measurable disease.

Exclusion Criteria

  • Active or untreated types of lymphoma or other cancers needing systemic treatment.
  • Serious active infections or history of HIV.
  • Severe graft-versus-host disease or need for life support.
  • Recent use of certain treatments or therapies.
  • Pregnant or breastfeeding women.
  • Unable to follow birth control guidelines during and after the study.
  • Need for high-dose steroids or other specific treatments.
  • Conditions that could risk study outcomes or life expectancy under 60 days.
  • History of certain transplants for those with PID LPD or AID LPD.
  • Previous systemic therapy for PTLD for those with EBV+ PTLD.

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