ALLELE
Research type
Research Study
Full title
Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)
IRAS ID
272571
Contact name
Sridhar Chaganti
Contact email
Sponsor organisation
Atara Biotherapeutics, Inc.
Eudract number
2017-002949-30
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as “glandular fever”. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, for people whose immune system is not working properly (like people who have had a transplant and those who have immune disorders), EBV can cause certain diseases where cells grow abnormally. EBV-associated Post-Transplant Lymphoproliferative Disease (EBV-PTLD) is a condition that can occur after a solid organ transplant (SOT) or allogeneic haematopoietic cell transplant (HCT) where EBV infects immune cells in the blood, called B cells. In patients who have had an SOT or a HCT, their immune system is suppressed because of the transplant, and these infected immune cells can become cancerous.
Tabelecleucel is made by taking donor cells from a healthy person, growing the cells that fight EBV (EBV-CTLs) in a laboratory for several weeks, and then storing them in a freezer until they are matched to a patient in need of treatment. No genetic modifications are done to the cells. This process is repeated using multiple donors in order to create a library of tabelecleucel products.
The purpose of this study is to test how well tabelecleucel works to treat EBV-PTLD following SOT or HCT in patients who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen.
Up to 66 participants will enroll in this research study, at approximately 50 locations worldwide. Participants may be in the study for up to 5 years in total each, including 12 months of treatment.REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0085
Date of REC Opinion
17 Jul 2020
REC opinion
Further Information Favourable Opinion