EBV201: Immunotherapy for Epstein-Barr Virus-Associated Cancers

Study of Allogeneic Epstein-Barr Virus Cytotoxic T Lymphocytes (EBV-CTLs) in EBV-Associated Viremia or Malignancies

Category:

Leukemia / Lymphoma

Diseases Treated:

Lymphoma

Eligibility Overview:

  • Epstein-Barr Virus (EBV) lymphoma or EBV-associated lymphoproliferative disorder
  • Primary or acquired immunodeficiency
  • Appropriate HLA partially-matched and restricted EBV-Cytotoxic T Lymphocytes (EBV-CTLs)
  • No other satisfactory therapies available to treat EBV disease
  1. Brief Summary

    Epstein-Barr Virus infection can play a role in a number of serious diseases, including lymphoproliferative disorders (LPDs). These may include post-transplant LPD, human immunodeficiency virus (HIV)-associated lymphoma, and Hodgkin lymphoma, among others. Those who fail standard therapies often have limited survival.

    This clinical trial will provide human leukocyte antigen (HLA) partially-matched third-party allogeneic EBV-CTLs for the treatment of EBV lymphomas/LPDs in patients with primary or acquired immunodeficiency.

    Primary Objective

    • To provide access to EBV-CTLs to patients with EBV-associated malignancies for whom there are no other satisfactory therapeutic options and who are not eligible for other EBV-CTL clinical trials

    Eligibility Criteria

    Inclusion criteria include:

    • Diagnosis of EBV+ LPD or lymphoma
    • EBV-lymphoma or LPD post-alloHCT, post-SOT, or in the context of a documented underlying primary/congenital or acquired immunodeficiency (e.g., HIV)
    • Appropriate HLA partially-matched and restricted EBV-CTLs
    • No other satisfactory therapies available to treat EBV+ disease
    • Ineligible for other trials supporting development of EBV-CTLs
    • ECOG performance status ≤3 for patients older than 16 years
    • Lansky score ≥20 for patients 16 years old and younger

    Exclusion Criteria include:

    • Need for antimetabolite agents or extracorporeal photopheresis
    • Need for vasopressor or ventilator support, unless caused by the EBV-driven process

    Study Design

    Multi-center, expanded access protocol

    Study Sites

    St. Jude Children’s Research Hospital and collaborating sites in the U.S.
    Memphis, Tennessee

  2. About this study

    Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as “mono.” Almost all adults have had EBV.  For most people, EBV never causes a health problem. However, EBV can cause certain diseases that cause cells to grow abnormally in some people. The people at highest risk are those who have had a transplant and those who have immune disorders.

    Researchers have created special immune cells in the laboratory that may help these at-risk patients. These cells are called EBV-Cytotoxic T Lymphocytes (EBV-CTLs). EBV-CTLs are made by taking donor cells from a healthy person. Researchers grow the cells in a laboratory for several weeks to teach them to recognize and destroy EBV infected cells. Afterwards, the cells are frozen until they are matched to a patient who needs treatment.   

    Patients who participate in this study will be given EBV-CTLs. Previous clinical trials have studied EBV-CTLs. However, this treatment has not approved by the U.S. Food and Drug Administration.  

    Purpose of this clinical trial

    The main purpose of this study is to give EBV-CTLs to patients who have no other treatment options. Researchers also want to find out how patients respond to treatment with EBV-CTLs.

    Eligibility overview

    • Epstein-Barr Virus (EBV) lymphoma or EBV-associated lymphoproliferative disorder
    • Primary or acquired immunodeficiency
    • Appropriate HLA partially-matched and restricted EBV-Cytotoxic T Lymphocytes (EBV-CTLs)
    • No other satisfactory therapies available to treat EBV disease
  3. EBV201 Quick View
    Sponsors Atara Biotherapeutics
    ClinicalTrials.gov identifier NCT02822495
    Estimated Enrollment 40 (4 at St. Jude)
    Study Type Expanded Access
    Conditions Epstein-Barr Virus Lymphoma
    Epstein-Barr Virus-Associated Lymphoproliferative Disorders
    Epstein-Barr Virus-Associated Viremia
    Ages All ages
    Principal investigator Ashok Srinivasan, MD – St. Jude 
    Study Sites St. Jude Children's Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss EBV201 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.