Expanded Access Protocol for Tabelecleucel for Patients With EBV-Associated Viremia or Malignancies (ATA129-EAP-901)

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. Identifier: NCT02822495
Expanded Access Status : Available
First Posted : July 4, 2016
Last Update Posted : October 12, 2018
Information provided by (Responsible Party):
Atara Biotherapeutics

Brief Summary:
The primary objective of this protocol is to provide expanded access to tabelecleucel to patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disorder (EBV+ PTLD), EBV+ primary immunodeficiency-associated lymphoproliferative disease (EBV+ PID LPD), EBV+ acquired immunodeficiency-associated LPD (EBV+ AID LPD), EBV+ leiomyosarcoma (EBV+ LMS), or EBV viremia, 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.

Condition or disease Intervention/treatment
Epstein-Barr Virus-Related Post-Transplant Lymphoproliferative Disorder Epstein-Barr Virus Associated Lymphoproliferative Disorder Epstein-Barr Virus Associated Lymphoma Epstein-Barr Virus-Related Lymphoma Lymphoproliferative Disorders Epstein-Barr Virus Infections Epstein-Barr Viraemia Lymphoma, AIDS-Related Epstein-Barr Virus Primary Immunodeficiency-associated Lymphoproliferative Disease Leiomyosarcoma Biological: tabelecleucel

Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
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

Intervention Details:
  • Biological: tabelecleucel
    Tabelecleucel is an off-the-shelf, allogeneic T-cell 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

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
  2. Any of the following evidence of EBV positivity:

    1. Biopsy showing EBV+ disease
    2. A combination of circulating EBV DNA and radiographic appearance consistent with an EBV+ malignancy (if biopsy is not clinically feasible in the opinion of the treating physician)
    3. For patients with EBV viremia only: 2 serial serum EBV DNA assays performed at least 4 weeks apart showing detectable EBV viremia
  3. Relapsed or refractory disease, defined as failure to achieve response (ie, complete response [CR] or partial response [PR]) or recurrence of disease following first line therapy, ie, systemic therapy for EBV-related malignancy or viremia that includes an anti-CD20 antibody, except in subjects with CD20 negative disease. Reduction of immunosuppression will not be considered as first-line therapy. Patients with CD20+ PTLD following SOT must have failed anti-CD20 antibody therapy plus an additional systemic therapeutic agent, typically chemotherapy. Patients with CD20 negative PTLD must have failed first-line chemotherapy.
  4. Not eligible for any other study supporting clinical 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. 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 Cycle 1 Day 1, or within 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 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 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, either of whom are unwilling to use a highly effective method of contraception

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 identifier (NCT number): NCT02822495

Contact: Minoti Hiremath, MBBS, PhD (650) 491-5773
Contact: Hillary Dinh, PhD (805) 309-2970

Sponsors and Collaborators
Atara Biotherapeutics
Study Director: Minoti Hiremath, MBBS, PhD Atara Biotherapeutics

Responsible Party: Atara Biotherapeutics Identifier: NCT02822495     History of Changes
Other Study ID Numbers: ATA129-EAP-901
EBV-CTL-201 ( Other Identifier: Atara Biotherapeutics )
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Keywords provided by Atara Biotherapeutics:
Lymphoproliferative Disorders
Epstein-Barr Virus
Epstein-Barr Viremia
Post Transplant Lymphoproliferative Disorder
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
Primary immune deficiency disorder
Acquired immune deficiency

Additional relevant MeSH terms:
Virus Diseases
Immunologic Deficiency Syndromes
Lymphoproliferative Disorders
Epstein-Barr Virus Infections
Lymphoma, AIDS-Related
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Systemic Inflammatory Response Syndrome
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin