A Study to Evaluate Tabelecleucel in Participants with Epstein-barr Virus-associated Diseases

Description

The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.

Conditions

Epstein-Barr Virus (EBV)-associated Diseases, EBV+ Lymphoproliferative Disease with Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease with Acquired (non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD), EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant, Stem Cell Transplant Complications, EBV+ Sarcomas, Leiomyosarcoma

Study Overview

Study Details

Study overview

The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases (EBVision)

A Study to Evaluate Tabelecleucel in Participants with Epstein-barr Virus-associated Diseases

Condition
Epstein-Barr Virus (EBV)-associated Diseases
Intervention / Treatment

-

Contacts and Locations

LOS Angeles

University of California Los Angeles (UCLA) (Adults and Pediatrics), LOS Angeles, California, United States, 90095

Orange

Children's Hospital of Orange County (Pediatrics [up to 25 years old]), Orange, California, United States, 92868

Palo Alto

Lucile Packard Children's Hospital Stanford (Pediatrics only), Palo Alto, California, United States, 94304

Sacramento

University of California Davis Comprehensive Cancer Center (Adults and Pediatrics), Sacramento, California, United States, 95817

Miami

Sylvester Comprehensive Cancer Center/ University of Miami, Miami, Florida, United States, 33136

Tampa

Moffit Cancer Center (Adults only), Tampa, Florida, United States, 33612

Atlanta

Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old]), Atlanta, Georgia, United States, 30322

Atlanta

Emory University/Winship Cancer Institute (Adults [>= 16 years]), Atlanta, Georgia, United States, 30322

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only), Chicago, Illinois, United States, 60611

Baltimore

University of Maryland Medical Center (Adults only), Baltimore, Maryland, United States, 21201

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of EBV+ disorder
  • * Eastern Cooperative Oncology Group performance status \<= 3 for participants aged \>= 16 years; Lansky score \>= 20 for participants from \>=1 year to \< 16 years
  • * Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator
  • * Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
  • * Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment, or known history of human immunodeficiency virus (HIV) infection
  • * Suspected or confirmed Grade \>= 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment
  • * Need for vasopressor or ventilatory support at the time of enrollment
  • * Prior therapy (in order of increasing washout period) prior to enrollment as follows:
  • * Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product and/ or any chemotherapy (systemic or intrathecal), targeted small molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression
  • * Within 8 weeks: prior tabelecleucel (\>8 weeks prior to enrollment) is permitted if response was obtained or if usual protocol-directed therapeutic options were not exhausted, for cellular therapies (chimeric antigen receptor therapies directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or virus-specific T-cells); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab)
  • * Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above
  • * Women who are breastfeeding or pregnant
  • * Unwilling to comply with protocol specified contraceptive/reproductive restrictions from enrollment through 90 days after the last treatment
  • * Ongoing need for daily steroids of \> 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants with CNS disease, protocol-specified dexamethasone is permitted and concludes by the time of enrollment)
  • * Any conditions that may put the study outcomes at undue risk (life expectancy \< 60 days or any life-threatening illness, medical condition, or organ system dysfunction)
  • * For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant
  • * For participants with EBV+ PTLD: prior systemic therapy for PTLD

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Atara Biotherapeutics,

Justin Wahlstrom, MD, STUDY_DIRECTOR, Atara Biotherapeutics

Study Record Dates

2029-05