Open-label study to assess efficacy and safety of taelecleucel in EBV
Research type
Research Study
Full title
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
IRAS ID
1003416
Contact name
Sridhar Chaganti
Contact email
Sponsor organisation
Atara Biotherapeutics, Inc.
Eudract number
2020-000177-25
Research summary
This is an open-label, phase 2 study to assess the efficacy and safety of Tabelecleucel in
participants with Epstein-Barr Virus-associated Diseases (EBV). EBV is the virus that
causes mononucleosis, also known as “glandular fever”. Almost all adults have had
EBV. For most people, approximately 95%, EBV never causes a health problem.
However, for people whose immune system is not working properly, EBV can cause
certain diseases where cells grow abnormally.
This study aims to determine the clinical benefit of a study medication named
tabelecleucel in participants with EBV. Tabelecleucel, is made by taking blood cells from
a healthy person (donor), growing the cells that fight EBV in a laboratory for several
weeks, and then storing them in a freezer until they are matched to a participants in need
of treatment. No genetic modifications are done to the cells.
Before participants can enter the study they will be checked to see if there is a study
medication that is a match to them, this is called an inventory check. Up to 228
participants are expected to take part in this study at around 50 locations worldwide.
There are 6 cohorts of participants based on the specific disease type of the participant.
The overall participation, including the screening period, may last up to 2 years and 4
weeks. Participants will be expected to complete 17-20 study visits and have 5
images/scans collected.
Depending on the cohort a participant is enrolled in, study procedures (such as blood
tests/physical exams/eye exams/tumour biopsies) will be required. Some cohorts require
lumbar punctures, PET Scans, CT Scans or MRI Scans.REC name
North East - York Research Ethics Committee
REC reference
20/NE/0252
Date of REC Opinion
12 Jan 2021
REC opinion
Further Information Favourable Opinion