We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

ATA129 for Allogeneic Hematopoietic Cell Transplant Subjects With EBV-PTLD After Failure of Rituximab (MATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03392142
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : March 2, 2018
Information provided by (Responsible Party):
Atara Biotherapeutics

Brief Summary:
This is a multicenter, open label, single-arm, phase 3 trial to assess the efficacy and safety of ATA129 for the treatment of EBV-associated post-transplant lymphoproliferative disease (PTLD) in the setting of allogeneic hematopoietic cell transplant (alloHCT) after failure of rituximab.

Condition or disease Intervention/treatment Phase
EBV-Related PTLD Biological: ATA129 Phase 3

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

This is a multicenter, open label, single-arm, phase 3 trial to assess the efficacy and safety of ATA129 for the treatment of EBV-PTLD in the setting of alloHCT after failure of rituximab.

ATA129 will be selected for the subject from the bank of available ATA129 cell products based on matching ≥ 2 HLA alleles, at least one of which is a restricting HLA allele, shared between the ATA129 donor and the subject's EBV-PTLD. Sites will provide high resolution subject and subject's graft donor HLA typing results and other information as required by the protocol.

ATA129 will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) ATA129 at a dose of 2×10^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label, Phase 3 Trial of ATA129 for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab (MATCH Study)
Actual Study Start Date : December 29, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ATA129
ATA129 will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) ATA129 at a dose of 2 x 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 multiple ATA129 cell products.
Biological: ATA129
ATA129 is an allogeneic cellular immunotherapy for the treatment of EBV-associated malignancies and diseases.
Other Names:
  • tabelecleucel
  • tab cel™
  • EBV-CTLs

Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 5 years ]
  2. Incidence of related and unrelated adverse events (AE), including AEs of interest [ Time Frame: 2 years ]
  3. Patient reported outcome: EQ-5D [ Time Frame: 2 years ]
  4. Patient reported outcome: Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) [ Time Frame: 2 years ]
  5. Duration of response (DOR) [ Time Frame: 2 years ]
  6. Rate of durable response [ Time Frame: 2 years ]
  7. PTLD progression-free survival (PFS) following best response [ Time Frame: 2 years ]
  8. Time to progression [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Prior allogeneic hematopoietic cell transplant
  2. A diagnosis of locally-assessed, biopsy-proven EBV-PTLD with a pathology sample available for central review
  3. Availability of appropriate partially HLA-matched and restricted ATA129 cell product
  4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease (using Lugano Classification response criteria) by positron emission tomography (PET)/computed tomography (CT). Baseline scans must be of acceptable quality to the central radiology laboratory prior to Cycle 1 Day 1.
  5. Failure of rituximab for first-line treatment of PTLD
  6. Males and females of any age
  7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 for patients aged > 16 years; Lansky score ≥ 20 for subjects from birth to 16 years
  8. Underlying primary disease, for which the subject underwent transplant, is in morphologic remission
  9. Adequate organ function

    1. Absolute neutrophil count ≥ 500/µL, with or without cytokine support
    2. Platelet count ≥ 50,000/µL, with or without transfusion support; platelet count < 50,000/µL but ≥ 20,000/µL, with or without transfusion support, is permissible if the subject has not had Grade ≥ 2 bleeding in the prior 6 months (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 4.03)
    3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) < 3 x the upper limit of normal (ULN); however, ALT, AST, and TBILI each ≤ 5 x ULN is acceptable if the elevation is considered by the investigator to be due to PTLD involvement of the liver
    4. Creatinine < 3 x ULN
  10. Subject or subject's representative is willing and able to provide written informed consent

Exclusion Criteria:

  1. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
  2. History of central nervous system (CNS) PTLD
  3. Grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment
  4. Ongoing or recent use of a checkpoint inhibitor (eg, nivolumab, pembrolizumab, ipilimumab) within three drug half-lives from the most recent dose to Cycle 1 Day 1
  5. Active adenovirus viremia
  6. Need for vasopressor or ventilatory support
  7. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to Cycle 1 Day 1
  8. Treatment with EBV-targeted cytotoxic T lymphocytes, chimeric antigen receptor (CAR)-T cells directed against B cells, or unselected donor lymphocyte infusion (DLI) within 8 weeks of Cycle 1 Day 1
  9. Pregnancy
  10. Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
  11. Inability to comply with study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392142

Contact: Atara Biotherapeutics (805) 603-4856 clinicaltrials@atarabio.com

United States, Florida
University of Miami Leonard M. Miller School of Medicine - Miami Transplant Institute Recruiting
Miami, Florida, United States, 33136
Contact: Amer Beitinjaneh, MD    305-243-6626    abeitinjaneh@miami.edu   
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, MD    404-727-4995    ewaller@emory.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Armin Ghobadi, MD    314-747-8439    arminghobadi@wustl.edu   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: David Loeb, MD, PhD    718-741-2342    dloeb@montefiore.org   
United States, North Carolina
UNC Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Marcie Riches, MD    919-966-7746    marcie_riches@med.unc.edu   
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Ashok Srinivasan, MD    901-595-4720    ashok.srinivasan@stjude.org   
Sponsors and Collaborators
Atara Biotherapeutics
Study Director: Willis H Navarro, MD Atara Biotherapeutics
Study Director: Akshay Sudhindra, MD Atara Biotherapeutics

Responsible Party: Atara Biotherapeutics
ClinicalTrials.gov Identifier: NCT03392142     History of Changes
Other Study ID Numbers: ATA129-EBV-301
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atara Biotherapeutics:
Allogeneic Hematopoietic Cell Transplant
Lymphoproliferative Disorders
Epstein-Barr Virus
Post-transplant lymphoproliferative disease
EBV-associated PTLD

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents