Multicenter, Open Label, Phase 3 Trial of ATA129 for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)
Sponsor: |
Atara Biotherapeutics, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR0163 |
U.S. Govt. ID: |
NCT03394365 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as mono. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, when their immune system is not working properly (like people who have had a transplant and must be on medications that suppress their immune system), 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) where EBV infects immune cells in your blood, called B cells. In patients who have had an SOT, their immune system is suppressed to prevent the body from rejecting the transplanted organ, and these infected immune cells can lead to cancer. The purpose of this study is to test how well the EBV-CTLs work to treat EBV-PTLD following SOT in patients who have failed rituximab or rituximab plus chemotherapy treatment and to see what side effects happen. Your participation will help us to understand more about EBV-CTLs.
Investigator
Ran Reshef, MD
Have you had a prior kidney, liver, heart, lung, pancreas, small bowel (or any combination of these) transplant? |
Yes |
No |
Have you been diagnosed with EBV-associated Post-Transplant Lymphoproliferative Disease (EBV-PTLD)? |
Yes |
No |