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

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: NCT02822495
Expanded Access Status : Available
First Posted : July 4, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Atara Biotherapeutics

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.

Condition or disease Intervention/treatment
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 Biological: 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.

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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 being investigated as 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

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.


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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+ 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

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
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Contact: Minoti Hiremath, MBBS, PhD 650-491-5773 clinicalstudies@atarabio.com

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

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Responsible Party: Atara Biotherapeutics
ClinicalTrials.gov Identifier: NCT02822495    
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: April 5, 2019
Last Verified: April 2019
Keywords provided by Atara Biotherapeutics:
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)
Additional relevant MeSH terms:
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Viremia
Lymphoma
Nasopharyngeal Carcinoma
Leiomyosarcoma
Lymphoma, AIDS-Related
Lymphoproliferative Disorders
Immunologic Deficiency Syndromes
Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation