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Study of Allogeneic EBV-CTLs in EBV-Associated Viremia or Malignancies

Expanded access is currently available for this treatment.
Verified March 2017 by Atara Biotherapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02822495
First Posted: July 4, 2016
Last Update Posted: March 7, 2017
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.
Information provided by (Responsible Party):
Atara Biotherapeutics
  Purpose
This is a multicenter expanded access protocol to provide human leukocyte antigen (HLA) partially-matched third-party allogeneic EBV-CTLs for the treatment of EBV-associated viremia and disease for which there is no comparable or satisfactory alternative therapy to treat the patient's disease or condition. Patients must not be eligible to enroll in clinical trials designed to support the development and marketing approval of Atara EBV-CTLs.

Condition Intervention
Epstein-Barr Virus-Associated Lymphoproliferative Disorder Epstein-Barr Virus Lymphoma Epstein-Barr Virus-Related Post-Transplant Lymphoproliferative Disorder Epstein-Barr Virus-Associated Viremia Biological: Epstein-Barr Virus Cytotoxic T Lymphocytes (EBV-CTLs)

Study Type: Expanded Access     What is Expanded Access?
Official Title: Multicenter Expanded Access Protocol of Allogeneic Epstein-Barr Virus Cytotoxic T Lymphocytes (EBV-CTLs) for Patients With EBV-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies

Resource links provided by NLM:


Further study details as provided by Atara Biotherapeutics:

Intervention Details:
    Biological: Epstein-Barr Virus Cytotoxic T Lymphocytes (EBV-CTLs)
    EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
Detailed Description:
This is a multicenter expanded access protocol to provide human leukocyte antigen (HLA) partially-matched third-party allogeneic EBV-CTLs for the treatment of EBV-associated viremia and disease for which there is no comparable or satisfactory alternative therapy to treat the patient's disease or condition. Patients must not be eligible to enroll in clinical trials designed to support the development and marketing approval of Atara EBV-CTLs. Allogeneic third-party EBV-CTL will be selected for the patient from the bank of available EBV-CTL cell product lots based on having a partial HLA match and having an appropriate HLA restriction shared between the EBV-CTL donor and the patient's EBV associated viremia/disease or the patient, as appropriate for the disease setting. EBV-CTLs will be administered in cycles lasting 5 weeks (35 days). During each cycle, patients will receive intravenous (IV) EBV-CTLs on Days 1, 8, and 15, followed by an observation period to complete a 35-day cycle.
  Eligibility

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
Criteria

Inclusion Criteria:

  1. Any of the following diagnoses of EBV-associated disease:

    1. EBV+ post-transplant lymphoproliferative disease (PTLD) after allogeneic hematopoietic cell transplant (alloHCT) or solid organ transplant (SOT)
    2. EBV-associated lymphoproliferative disorders (LPD) associated with congenital or acquired immunodeficiency
    3. EBV-associated lymphomas and LPDs not associated with immunodeficiency (biopsy required) (eg, EBV+ diffuse large B cell lymphoma (DLBCL) of the elderly)
    4. Other EBV-associated malignancies (biopsy required) including nasopharyngeal carcinoma, EBV+ gastric cancer, EBV+ leiomyosarcoma
    5. EBV+ hemophagocytic lymphohistiocytosis (HLH)
    6. Persistent EBV viremia
  2. Evidence of EBV positivity as follows:

    1. Biopsy showing EBV+ disease (strongly recommended unless required, as noted in criterion #1), OR
    2. A combination of circulating EBV DNA AND radiographic appearance consistent with an EBV+ malignancy, if biopsy is not clinically feasible, unless required per criterion #1, OR
    3. For EBV viremia only, fulfillment of inclusion criteria 1f
  3. Availability of appropriate HLA partially-matched and restricted EBV-CTLs
  4. No other approved alternative therapies available for treatment of EBV+ viremia/disease
  5. Not eligible for any other trials supporting development of Atara EBV-CTLs
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 for patients aged > 16 years; Lansky score ≥ 20 for patients ≤ 16 years
  7. For patients with PTLD in the alloHCT setting, the underlying disease for which alloHCT transplant was performed is in morphologic remission
  8. Adequate organ function per the following (unless deemed to be caused by the underlying EBV-driven process which EBV-CTLs are intended to treat, or its prior therapy):

    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 patient 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) and aspartate aminotransferase (AST) < 3× the upper limit of normal (ULN) and total bilirubin < 2.5×ULN; values up to 5×ULN for ALT, AST, and/or total bilirubin are acceptable if the elevation is considered due to EBV-associated disease involvement of the liver
    4. Creatinine < 3×ULN
  9. Patient or patient's representative is willing and able to provide written informed consent

Exclusion Criteria:

  1. Any investigational therapy received ≤ 4 weeks prior to Cycle 1 Day 1 (co-enrollment in a non-interventional study or a study for sample collection only is permitted)
  2. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 0.5 mg/kg, as prednisone equivalent, require discussion with the medical monitor
  3. Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process which EBV-CTLs are intended to treat
  4. Antithymocyte globulin, alemtuzumab, or similar anti-T cell antibody therapy, or T cell therapy (donor lymphocyte infusion, other cytotoxic T lymphocytes) ≤ 4 weeks prior to Cycle 1 Day 1
  5. Pregnancy, except when, in the opinion of the investigator in consultation with the medical monitor, the risk/benefit of EBV-CTL therapy favors proceeding
  6. Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
  7. Inability to comply with study procedures
  Contacts and Locations
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): NCT02822495


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

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Contact: Patrick Stiff, MD    708-327-3148    pstiff@lumc.edu   
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: Sarah Nikiforow, MD, PhD    617-632-6640    snikiforow@partners.org   
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Aleksandr Lazaryan, MD    612-624-0123    alazarya@umn.edu   
United States, Missouri
Washington University, School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Armin Ghobadi, MD    314-454-2743    aghobadi@dom.wustl.edu   
United States, New York
The Children's Hospital at Montefiore
Bronx, New York, United States, 10467
Contact: Kris Mahadeo, MD, MPH    718-741-2285    kmahadeo@montefiore.org   
Columbia University Medical Center
New York, New York, United States, 10032
Contact: Ran Reshef, MD    212-342-0530    rr3036@cumc.columbia.edu   
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Susan Prockop, MD    212-639-6715    prockops@mskcc.org   
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact: Marcie Riches, MD    919-966-7746    marcie_riches@med.unc.edu   
United States, Ohio
The Ohio State University - Arthur G. James Cancer Center Hospital
Columbus, Ohio, United States, 43210
Contact: Robert Baiocchi, MD    614-293-3196    robert.baiocchi@osumc.edu   
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Contact: Eneida Nemecek, MD    503-494-0829    nemeceke@ohsu.edu   
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Donald Tsai, MD    215-614-0037    donald.tsai@uphs.upenn.edu   
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Contact: Nancy J Bunin, MD    215-590-2255    buninn@email.chop.edu   
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Contact: Ashok Srinivasan, MD    901-595-4720    ashok.srinivasan@stjude.org   
Sponsors and Collaborators
Atara Biotherapeutics
Investigators
Study Director: Willis Navarro, MD Atara Biotherapeutics
  More Information

Responsible Party: Atara Biotherapeutics
ClinicalTrials.gov Identifier: NCT02822495     History of Changes
Other Study ID Numbers: EBV-CTL-201
First Submitted: June 30, 2016
First Posted: July 4, 2016
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Atara Biotherapeutics:
Lymphoproliferative Disorders
Epstein-Barr Virus
Epstein-Barr Viremia
Post Transplant Lymphoproliferative Disorder
EBV-PTLD
Solid Organ Transplant
Hematopoietic Cell Transplant
primary immunodeficiency
acquired immunodeficiency
Epstein-Barr Virus Lymphoma

Additional relevant MeSH terms:
Disease
Virus Diseases
Lymphoproliferative Disorders
Viremia
Pathologic Processes
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation