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Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

Primary Purpose

Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
tabelecleucel
Sponsored by
Atara Biotherapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Epstein-Barr Virus (EBV) Infections focused on measuring Epstein-Barr Virus (EBV), Solid Organ Transplant (HCT), Hematopoietic Cell Transplant (SOT), Primary Immunodeficiency (PID), Acquired Immunodeficiency (AID), Epstein-Barr Virus-associated Lymphoma, HIV/AIDS Lymphoma, Rheumatoid Arthritis and Lymphoma, Allogeneic, Off-The-Shelf T-cell Immunotherapy, Tumor Necrosis Factor (TNF)-alpha Inhibitors and Lymphoma, Inflammatory Bowel Disease and Lymphoma, Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL), Epstein-Barr Virus+ associated Nasopharyngeal Carcinoma (EBV+ NPC), Epstein-Barr Virus+ associated Leiomyosarcoma (EBV+ LMS)

Eligibility Criteria

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Inclusion Criteria:

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

    1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
    2. EBV+ PTLD following solid organ transplant (SOT)
    3. Persistent EBV viremia and known or suspected immunodeficiency
    4. EBV+ LPD that has developed in the setting of an AID
    5. EBV+ LPD that has developed in the setting of a known or suspected PID
    6. EBV+ LMS
    7. EBV+ NPC
  2. The evidence of EBV positivity
  3. Relapsed or refractory disease, defined as failure to achieve response (ie, complete response or partial response) or recurrent disease following first line therapy, ie, systemic therapy for EBV-related malignancy or viremia for which there are no appropriate therapies.
  4. Not eligible for any other Atara clinical development study
  5. For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be 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. Participant or participant's representative is willing and able to provide written informed consent

Exclusion Criteria:

  1. Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma
  2. Prior treatment with any investigational product within 4 weeks of first treatment with tabelecleucel, or within 5 half-lives from the most recent dose to first treatment with tabelecleucel
  3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or 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 cytotoxic T lymphocytes [CTLs]) <= 4 weeks prior to first treatment with tabelecleucel
  6. Pregnancy
  7. Female of childbearing potential or male with a female partner of childbearing potential, either of whom are unwilling to use a highly effective method of contraception

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2016
    Last Updated
    June 13, 2023
    Sponsor
    Atara Biotherapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02822495
    Brief Title
    Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
    Official Title
    Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Atara Biotherapeutics

    4. Oversight

    5. Study Description

    Brief Summary
    The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
    Detailed Description
    Participants for whom there are no other appropriate therapeutic options and who are not eligible to enroll in other tabelecleucel clinical studies, may be enrolled in this study. After the screening period, participants will receive intravenous infusions of tabelecleucel (1.6 to 2 × 10^6cells/kg) on Day 1, Day 8, and Day 15 of every 35-day cycle. Clinical assessment of disease response is recommended approximately 15 days after the last dose of tabelecleucel to assess the need for additional treatment. The end of expanded access protocol (EAP) visit should be performed at 30 days after the last dose of tabelecleucel.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Epstein-Barr Viremia, Lymphoma, AIDS-related, Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Primary Immunodeficiency (PID), Leiomyosarcoma (LMS), Nasopharyngeal Carcinoma (NPC), Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Acquired Immunodeficiency (AID), Solid Organ Transplant Complications, Stem Cell Transplant Complications
    Keywords
    Epstein-Barr Virus (EBV), Solid Organ Transplant (HCT), Hematopoietic Cell Transplant (SOT), Primary Immunodeficiency (PID), Acquired Immunodeficiency (AID), Epstein-Barr Virus-associated Lymphoma, HIV/AIDS Lymphoma, Rheumatoid Arthritis and Lymphoma, Allogeneic, Off-The-Shelf T-cell Immunotherapy, Tumor Necrosis Factor (TNF)-alpha Inhibitors and Lymphoma, Inflammatory Bowel Disease and Lymphoma, Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL), Epstein-Barr Virus+ associated Nasopharyngeal Carcinoma (EBV+ NPC), Epstein-Barr Virus+ associated Leiomyosarcoma (EBV+ LMS)

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    tabelecleucel
    Other Intervention Name(s)
    tab-cel®, ATA129, EBV-CTL
    Intervention Description
    Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Any of the following diagnoses of EBV+ malignancies or disease: EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) EBV+ PTLD following solid organ transplant (SOT) Persistent EBV viremia and known or suspected immunodeficiency EBV+ LPD that has developed in the setting of an AID EBV+ LPD that has developed in the setting of a known or suspected PID EBV+ LMS EBV+ NPC The evidence of EBV positivity Relapsed or refractory disease, defined as failure to achieve response (ie, complete response or partial response) or recurrent disease following first line therapy, ie, systemic therapy for EBV-related malignancy or viremia for which there are no appropriate therapies. Not eligible for any other Atara clinical development study For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be in morphologic remission Adequate organ function per the following: Absolute neutrophil count >= 500/μL, with or without cytokine support Platelet count >= 20,000/μL, with or without transfusion support Participant or participant's representative is willing and able to provide written informed consent Exclusion Criteria: Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma Prior treatment with any investigational product within 4 weeks of first treatment with tabelecleucel, or within 5 half-lives from the most recent dose to first treatment with tabelecleucel Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or equivalent) Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or T-cell immunotherapy (donor lymphocyte infusion, other cytotoxic T lymphocytes [CTLs]) <= 4 weeks prior to first treatment with tabelecleucel Pregnancy Female of childbearing potential or male with a female partner of childbearing potential, either of whom are unwilling to use a highly effective method of contraception
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aditi Mehta, DO
    Organizational Affiliation
    Atara Biotherapeutics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

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