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Participants who have failed rituximab will receive IV tabelecleucel.

Participants who have failed both rituximab and chemotherapy will receive IV tabelecleucel.

Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

tabelecleucel

Aditi Mehta, DO

Amandeep Salhotra, MD

Huynh Cao, MD

Neena Kapoor, MD

Herbert Eradat, MD

William Asch, MD

Udeme Ekong, MD

Amer Beitinjaneh, MD, MPH, MSc

Suhag Parikh, MD

Jean Koff, MD

Sonali Chaudhury, MD

Satayaijt Kosuri, MD

Patrick Hagen, MD

Jean Yared, MD

Sarah Nikiforow, MD

Armin Ghobadi, MD

Koen Van Besien, MD

Ran Reshef, MD

Kevin Curran, MD

Michael Kent, MD

Matthew McKinney, MD

Hanna Rabi, MD

Robert Baiocchi, MD, PhD

Nemecek Eneida, MD

Nancy Bunin, MD

Michelle Hudspeth, MD

Bhagirathbhai Dholaria, MD

Luis Pineiro, MD

Tamra Slone, MD

Kris Michael Mahadeo, MD

James Butterworth, MD

Shyam Panicker, MD, MBBS, MRCP, FRACP, FRCPA

Daniel Chambers, MBBS, MRCP, FRACP, MD

Devendra Hiwase, MD

Rachel Conyers, MD, MBBS, FRACP

Duncan Purtill, MD, MBBS, FRACP, FRCPA

Nina Worel, MD

Willems Evelyne, MD

Daan Dierickx, MD

Victor Lewis, MD

Joerg Krueger, MD

Arjun Law, MD

Edouard Forcade, MD

Eolia Brissot, MD

Franck Morschhauser, MD

Benedicte Neven, MD

Sylvain Choquet, MD

Roberto Cairoli, MD

Patrizia Comoli, MD

Simona Sica, MD

Franco Locatelli, MD

Giaccone Luisa, MD

Eva González-Barca, MD

Lucrecia Yanez, MD

Pere Barba, MD

Gillen Oarbeascoa, MD

Jose Perez-Simon, MD

Juan Montoro, MD

Sridhar Chaganti, MD

Daniele Avenoso, MD

Eduardo Olavarria, MD

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.

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.

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

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

Atara Biotherapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT03394365	Epstein-Barr Vi... Solid Organ Tra... Lymphoprolifera... Allogeneic Hema... Stem Cell Trans...	tabelecleucel	-	Atara Biotherapeutics
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	NCT03394365	Epstein-Barr Vi... Solid Organ Tra... Lymphoprolifera... Allogeneic Hema... Stem Cell Trans...	tabelecleucel	-	Atara Biotherapeutics

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