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

June 13, 2023 updated by: Atara Biotherapeutics

Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies

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.

Study Overview

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.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Aditi Mehta, DO, Atara Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimated)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ATA129-EAP-901
  • EBV-CTL-201 (Other Identifier: Atara Biotherapeutics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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