Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Solid Tumor	NCT ID:	NCT03394365
Trial Phases:	Phase III	Protocol IDs:	ATA129-EBV-302 (primary) NCI-2018-00043
Eligibility:	0 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Atara Biotherapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT03394365

Summary

The purpose of this study is to determine the clinical benefit and characterize the
safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated
post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ
transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2)
allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Objectives

This is a multicenter, open-label, phase 3 study to assess the efficacy and safety of
tabelecleucel for the treatment of EBV+ PTLD in the setting of SOT after failure of
rituximab and rituximab plus chemotherapy (SOT cohort) or HCT after failure of rituximab
(HCT cohort).

Enrollment will be preceded by confirmation of availability of partially human leukocyte
antigen (HLA) matched and restricted tabelecleucel for the participant.

Study procedures and product administration will be the same for each cohort.
Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each
cycle, participants will receive intravenous tabelecleucel at a dose of 2×10^6 cells/kg
on Days 1, 8, and 15, followed by observation through Day 35. Treatment will continue
until maximal response, unacceptable toxicity, initiation of non protocol therapy, or
failure of tabelecleucel with up to 2 different HLA restrictions (SOT cohort) or up to 4
different HLA restrictions (HCT cohort). The study includes a total of 5 years of
follow-up for disease and survival status.

This protocol has been amended to include the HCT cohort from clinical study
ATA129-EBV-301 (NCT03392142).

NOTE, 29 April 2020: Enrollment is temporarily paused at study site/locations with status
"active, not recruiting" due to COVID-19 restrictions.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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