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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 Chemo

Clinical Trial Details

This clinical trial is for men and women who have Epstein-Barr Virus- Associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD) following a solid organ transplant or Allogeneic Hematopoietic Cell Transplant (HCT) who did not respond well to treatment with rituximab or rituximab and chemotherapy.
   
The purpose of this study is to test how well tabelecleucel works for these groups of patients and to see what side effects may occur. 

Tabelecleucel is made by taking donor cells from a healthy person, 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 patient in need of treatment.
  
Treatment with tabelecleucel is experimental which means it is not yet approved by the United States Food and Drug Administration (FDA).

All study participants will receive tabelecleucel via an intravenous infusion (IV). Participation in this study will last for approximately 5 years. 

Key Eligibility: 
  1. Prior solid organ transplant of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these; or prior allogeneic Allogeneic Hematopoietic Cell Transplant (HCT)
  2. A diagnosis of Epstein-Barr Virus- Associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD)

Detailed eligibility will be reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1911021137

ClinicalTrials.gov:

NCT03394365

Sponsor:

ATA129-EBV-302

Status

Open to Enrollment

Age Group

Adult

Sponsor