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Expanded Access Protocol for Tabelecleucel in Subjects With EBV-Associated Viremia or Malignancies

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ClinicalTrials.gov Identifier: NCT02822495
Expanded Access Status : Available
First Posted : July 4, 2016
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Atara Biotherapeutics

Brief Summary:
The primary objective of this protocol is to provide access to tabelecleucel to patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disorder (EBV+ PTLD), EBV+ primary immunodeficiency lymphoproliferative disease (PID LPD), EBV+ acquired immunodeficiency (AID) LPD, and EBV viremia for whom there are no other approved therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.

Condition or disease Intervention/treatment
Epstein-Barr Virus-Associated Lymphoproliferative Disorder Epstein-Barr Virus Lymphoma Epstein-Barr Virus-Related Post-Transplant Lymphoproliferative Disorder Epstein-Barr Virus-Associated Viremia Biological: tabelecleucel

Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Multicenter Expanded Access Protocol of Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies



Intervention Details:
  • Biological: tabelecleucel
    Tabelecleucel is an allogeneic cellular immunotherapy for the treatment of EBV+ malignancies and diseases.
    Other Names:
    • tab-cel™
    • ATA129
    • EBV-CTL

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Any of the following diagnoses of EBV+ disease:

    1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) or solid organ transplant (SOT) and who cannot be treated under protocols designed to support drug development or registration
    2. Persistent EBV viremia as evidenced by 2 serial serum EBV deoxyribonucleic acid (DNA) assays showing detectable EBV viremia at least 4 weeks apart, and known or suspected immunodeficiency, or EBV viremia with a history of prior EBV+ malignancy
    3. EBV+ LPD that has developed in the setting of an AID
    4. EBV+ LPD that has developed in the setting of a known or suspected PID
  2. Evidence of EBV positivity as follows:

    1. Biopsy showing EBV+ disease, OR
    2. A combination of circulating EBV DNA AND radiographic appearance consistent with an EBV+ malignancy, if biopsy is not clinically feasible, OR
    3. For EBV viremia only, fulfillment of inclusion criteria 1b
  3. Relapsed or refractory disease, which is defined as:

    1. In patients with PTLD following HCT: relapsed after or refractory to reduction of immunosuppression and an anti-CD20 monoclonal antibody (unless investigator determines tumor to be CD20-) as a single agent or in combination with chemotherapy. Patients with CD20- disease must have failed chemotherapy alone.
    2. In patients with PTLD following SOT: relapse after or refractory to reduction of immunosuppression, an anti-CD20 monoclonal antibody (unless investigator determines tumor to be CD20-) plus anthracycline based chemotherapy. Patients with CD20- disease must have failed chemotherapy alone.
    3. In patients with EBV viremia: Viremia that persists or recurs despite therapy with an anti-CD20 monoclonal antibody
    4. In patients with PID LPD: relapsed after or refractory to an anti-CD20 monoclonal antibody (unless investigator determines tumor to be CD20-) as a single agent or in combination with a chemotherapy
    5. In patients with AID LPD: have failed at least two prior lines of therapy, one of which is an anti-CD20 monoclonal antibody (unless investigator determines tumor to be CD20-) plus anthracycline based chemotherapy (Note: Remission consolidation with an autologous or allogeneic stem cell transplant will not be considered as a separate line of therapy).
  4. Not eligible for any other studies supporting development of tabelecleucel
  5. For patients with PTLD in the allogeneic HCT setting, the underlying disease for which allogeneic HCT was performed is in morphologic remission
  6. Adequate organ function per the following:

    1. Absolute neutrophil count ≥ 500/μL, with or without cytokine support
    2. Platelet count ≥ 20,000/μL, with or without transfusion support
  7. Patient or patient's representative is willing and able to provide written informed consent

Exclusion Criteria:

  1. Burkitt's lymphoma, classical Hodgkin's lymphoma, plasmablastic lymphoma, or any T-cell lymphoma
  2. Any investigational therapy received within 4 weeks prior to Cycle 1 Day 1, except for therapy that is outside of 5 half-lives from the most recent dose to Cycle 1 Day 1
  3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day, as prednisone equivalent
  4. Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat
  5. Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or T-cell immunotherapy (donor lymphocyte infusion, other CTLs) ≤ 4 weeks prior to Cycle 1 Day 1
  6. Pregnancy
  7. Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception, except when, in the opinion of the treating physician in consultation with the medical monitor, the risk/benefit of tabelecleucel therapy favors proceeding
  8. Inability to comply with protocol 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): NCT02822495


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

  Show 24 Study Locations
Sponsors and Collaborators
Atara Biotherapeutics
Investigators
Study Director: Willis Navarro, MD Atara Biotherapeutics

Responsible Party: Atara Biotherapeutics
ClinicalTrials.gov Identifier: NCT02822495     History of Changes
Other Study ID Numbers: EBV-CTL-201
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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
HIV/AIDS lymphoma
Rheumatoid arthritis AND lymphoma
Allogeneic, off-the-shelf T-cell immunotherapy
TNF-alpha inhibitors AND lymphoma
Inflammatory bowel disease AND lymphoma

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