search
Back to results

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

Primary Purpose

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)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tabelecleucel
Sponsored by
Atara Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epstein-Barr Virus (EBV)-Associated Diseases focused on measuring Allogeneic, Off-The-Shelf T-cell Immunotherapy, Epstein-Barr Virus (EBV), Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL), Solid Organ Transplant (SOT), Hematopoietic Cell Transplant (HCT), EBVision

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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

Cohort-specific Inclusion Criteria:

  • For participants with PID LPD:

    • Newly diagnosed or relapsed/refractory LPD confirmed by biopsy-proven EBV+ LPD or positive cerebrospinal fluid (CSF) cytology with or without radiographically measurable intracranial disease with EBV detected in CSF
    • Participant must have systemic measurable disease and/ or CNS measurable disease
    • Definitive therapy (eg, allogeneic HCT, gene therapy) for the underlying PID is planned
    • Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD, as determined by the investigator
  • For participants with AID LPD:

    • Newly diagnosed or relapsed/refractory LPD confirmed by biopsy-proven EBV+ LPD or positive CSF cytology, with or without radiographically measurable intracranial disease, with EBV detected in CSF
    • Participant must have systemic measurable disease and/ or CNS measurable disease
    • Participants who are human immunodeficiency virus positive (HIV+) must meet both of the following criteria: Have an HIV viral load assessed by reverse transcription-polymerase chain reaction (RT-PCR) below the lower limit of detection and CD4 >= 50 cells/μL within 6 months prior to the first dose of tabelecleucel
    • Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD, as determined by the investigator
  • For participants with CNS PTLD:

    • Newly diagnosed or relapsed/refractory EBV+ CNS PTLD histologically confirmed by biopsy-proven EBV+ CNS PTLD or positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF
    • Participant may have systemic and CNS disease or CNS disease only
    • Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD, as determined by the investigator
  • For participants with EBV+ PTLD, where standard first line therapy (rituximab and/or chemotherapy) is not appropriate, including CD20-negative disease:

    • Newly diagnosed, biopsy-proven EBV+ PTLD
    • Ineligible for standard first-line therapy for EBV+ PTLD, as determined by the investigator
    • Participants must have systemic disease measurable per Lugano Classification criteria, except when contraindicated or mandated by local practice, then MRI may be used.
  • For participants with sarcoma, including LMS:

    • Newly diagnosed or failed systemic first-line therapy for EBV+ sarcoma. Participants with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ sarcoma, as determined by the investigator.
    • Biopsy-proven EBV+ sarcoma
    • Measurable disease using diagnostic PET/CT and/or MRI following RECIST 1.1 criteria
  • For participants with CAEBV:

    • Newly diagnosed or previously treated CAEBV
    • Detectable EBV viremia on at least 2 occasions at a minimum of 90 days apart
    • At least 3 active clinical findings (per Kimura H, et al. Front Immunol. 2017;8:1867) as: Fever >= 38.5°C; splenomegaly, lymphadenopathy, and/or hepatomegaly; cytopenia affecting at least 2 or 3 lineages in the peripheral blood (hemoglobin < 9 g/dL, platelets < 100 × 10^3/mL, neutrophils < 1 × 10^3/mL); hypogammaglobulinemia; hemophagocytosis; hepatitis; neuropathy; rash; and hydroa vacciniforme
  • For participants with EBV+ viremia with HLH:

    • Newly diagnosed or previously treated EBV+ viremia with HLH
    • A molecular diagnosis consistent with HLH-2004 trial (per Henter JI, et al. Pediatr Blood Cancer. 2007;48:124-31) OR 5 or more of the clinical symptoms (per Jordan MB, et al. Blood. 2011;118:4041-4052): Fever >= 38.5°C; splenomegaly; cytopenia affecting at least 2 or 3 lineages in the peripheral blood (hemoglobin < 9 g/dL, platelets < 100 × 10^3/mL, neutrophils < 1 × 10^3/mL); hypertriglyceridemia (fasting >= 265 mg/dL) and/or hypofibrinogenemia (<= 150 mg/dL); hemophagocytosis in bone marrow, spleen, lymph nodes, or liver; low or absent natural killer cell (NK-cell) activity; ferritin >= 500 ng/mL; and elevated soluble CD25

Exclusion Criteria:

  • Burkitt, T-cell (except in the setting of HLH), natural killer/T-cell lymphoma/LPD, Hodgkin, or transformed lymphoma
  • Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment
  • 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
  • Prior therapy (in order of increasing washout period) prior to enrollment as:

    • 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 for cellular therapies (EBV-CTLs, chimeric antigen receptor therapies directed at T cells or T-cell subsets, donor lymphocyte infusion, other CTLs); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab)
  • Unwilling to use protocol specified contraceptive methods
  • Women who are pregnant or breastfeeding
  • Ongoing need for daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (protocol-specified dexamethasone is permitted and concludes by the time of enrollment)
  • For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant

Sites / Locations

  • University of California Los Angeles (UCLA) (Adults and Pediatrics)Recruiting
  • Children's Hospital of Orange County (Pediatrics [up to 25 years old])Recruiting
  • Lucile Packard Children's Hospital Stanford (Pediatrics only)Recruiting
  • University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)Recruiting
  • Sylvester Comprehensive Cancer Center/ University of MiamiRecruiting
  • Moffit Cancer Center (Adults only)
  • Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])Recruiting
  • Emory University/Winship Cancer Institute (Adults [>= 16 years])
  • Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)Recruiting
  • University of Maryland Medical Center (Adults only)Recruiting
  • Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)Recruiting
  • University of Michigan Rogel Cancer Center (Adults and Pediatrics)Recruiting
  • University of Minnesota (Adults only)Recruiting
  • Washington University in St. Louis (Adults only)Recruiting
  • The Children's Hospital at Montefiore (Adults and Pediatrics)Recruiting
  • Columbia University Irving Medical Center (Adults only)
  • Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)Recruiting
  • Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)
  • The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)Recruiting
  • Oregon Health and Science University (Adults and Pediatrics)Recruiting
  • Medical University of South Carolina (Adults and Pediatrics)Recruiting
  • University of Texas Southwestern Medical Center (Pediatrics only)Recruiting
  • MD Anderson (Adults and Pediatrics)Recruiting
  • Medizinische Universität Graz (Adults only)Recruiting
  • Uniklinikum Salzburg Landeskrankenhaus (Adults only)Recruiting
  • Medizinische Universität Wien (Adults only)Recruiting
  • Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)Recruiting
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)Recruiting
  • Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)Recruiting
  • Hôpital Saint-Eloi (Adults and Pediatrics)Recruiting
  • Hôpital Universitaire Pitié Salpêtrière (Adults only)Recruiting
  • Hôpital Necker-Enfants Malades (Adults and Pediatrics)Recruiting
  • Azienda Ospedaliero-Universitaria Pisana (Adults only)Recruiting
  • Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)Recruiting
  • Ospedale Infantile Regina Margherita (Pediatrics only)Recruiting
  • Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)Recruiting
  • Hospital Universitario Ramón y Cajal (Adults only)Recruiting
  • Hospital Universitario Viegen del Rocio (Adults and Pediatrics)Recruiting
  • University Hospital Birmingham NHS Foundation Trust (Adults only)Recruiting
  • Great Ormond Street Hospital (Pediatrics only)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

EBV+ PID LPD

EBV+ AID LPD

EBV+ CNS PTLD

EBV+ PTLD (inappropriate for first-line therapy or CD20-negative)

EBV+ sarcoma, including LMS, or smooth muscle tumors

Arm Description

Participants with R/R or newly diagnosed EBV+ PID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.

Participants with R/R or newly diagnosed EBV+ AID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.

Participants with R/R or newly diagnosed EBV+ CNS PTLD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.

Participants with EBV+ PTLD for whom standard first-line therapy (rituximab or chemotherapy) is inappropriate, including CD20-negative disease, will receive IV tabelecleucel.

Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, including LMS or smooth muscle tumor, will receive IV tabelecleucel.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)

Secondary Outcome Measures

Overall survival (OS)
Duration of response (DOR)
Progression-free survival (PFS)
For EBV+ PID LPD cohort: Number of participants who reach definitive therapy (ie, allogeneic HCT) for the underlying disease
For EBV+ PID LPD cohort: Time to definitive therapy
For EBV+ sarcoma cohort, including LMS or smooth muscle tumors: Clinical benefit rate
For EBV+ sarcoma cohort, including LMS or smooth muscle tumors: ORR by immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria

Full Information

First Posted
September 14, 2020
Last Updated
October 23, 2023
Sponsor
Atara Biotherapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT04554914
Brief Title
A Study to Evaluate Tabelecleucel in Participants With Epstein-barr Virus-associated Diseases
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
May 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atara Biotherapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.
Detailed Description
This is a multicenter, multicohort, open-label, single-arm, Phase 2 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV-associated diseases. Participants will be enrolled in one of the following cohorts: EBV+ lymphoproliferative disease (LPD) in the setting of primary immunodeficiency (PID) (EBV+ PID LPD) that is relapsed and/or refractory (R/R) or newly diagnosed where standard first-line therapy is inappropriate EBV+ LPD in the setting of acquired (non-congenital) immunodeficiency (AID) (EBV+ AID LPD) that is R/R or newly diagnosed where standard first-line therapy is inappropriate EBV+ posttransplant lymphoproliferative disease (PTLD) involving the central nervous system (CNS) (EBV+ CNS PTLD) that is R/R or newly diagnosed where standard first-line therapy is inappropriate EBV+ PTLD where standard first-line therapy (rituximab or chemotherapy) is inappropriate, including cluster of differentiation antigen 20 (CD20)-negative disease EBV+ sarcomas, including leiomyosarcoma (LMS), or smooth muscle tumors that is rapidly progressive where standard first-line therapy is inappropriate Tabelecleucel will be administered in cycles lasting for 35 days. During each cycle, participants will receive tabelecleucel at a dose of 2 x 10^6 cells/kg intravenously (IV) weekly for 3 weeks, followed by observation through Day 35. Treatment will continue until maximal response, disease progression, unacceptable toxicity, or initiation of nonprotocol therapy for the underlying disease. For EBV+ sarcoma cohort, treatment will continue until disease progression, unacceptable toxicity, two consecutive complete responses (CRs), or up to 12 months from the first dose. Participants who fail to respond to initial tabelecleucel treatment may continue tabelecleucel with a different human leukocyte antigen (HLA) restriction (termed a Restriction Switch), if available; administration of tabelecleucel with up to four different HLA restrictions is allowed for any participant. After treatment is completed or discontinued, participants will complete a safety follow-up visit at 30 days after the last dose and then will enter a quarterly follow-up period. Participants without documented disease progression will be assessed every 3 months after the safety follow-up visit for continued evaluation of disease response until the end of study (EOS) visit at 24-month after first dose. Participants with disease progression any time prior to the EOS visit will continue to be followed every 3 months for survival status until the EOS visit. An adaptive 2-stage design will be used for each cohort in this study. For each cohort, 8 evaluable participants will be enrolled in Stage 1. The decision to move to Stage 2 enrollment will be based on an interim analysis of the first 8 evaluable participants in the cohort using investigator's assessment (per defined radiologic, clinical, and/or laboratory response criteria) who receive tabelecleucel and have at least 1 valid postbaseline disease response assessment. The number of participants enrolled in Stage 2 for each cohort will depend on the number of observed responders in Stage 1. Sponsor may decide not to move forward to Stage 2 in any cohort even if the criteria to move forward for that cohort are met. The decision not to move forward may also be based on data from one or other cohorts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Allogeneic, Off-The-Shelf T-cell Immunotherapy, Epstein-Barr Virus (EBV), Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL), Solid Organ Transplant (SOT), Hematopoietic Cell Transplant (HCT), EBVision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EBV+ PID LPD
Arm Type
Experimental
Arm Description
Participants with R/R or newly diagnosed EBV+ PID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
Arm Title
EBV+ AID LPD
Arm Type
Experimental
Arm Description
Participants with R/R or newly diagnosed EBV+ AID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
Arm Title
EBV+ CNS PTLD
Arm Type
Experimental
Arm Description
Participants with R/R or newly diagnosed EBV+ CNS PTLD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
Arm Title
EBV+ PTLD (inappropriate for first-line therapy or CD20-negative)
Arm Type
Experimental
Arm Description
Participants with EBV+ PTLD for whom standard first-line therapy (rituximab or chemotherapy) is inappropriate, including CD20-negative disease, will receive IV tabelecleucel.
Arm Title
EBV+ sarcoma, including LMS, or smooth muscle tumors
Arm Type
Experimental
Arm Description
Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, including LMS or smooth muscle tumor, will receive IV tabelecleucel.
Intervention Type
Biological
Intervention Name(s)
Tabelecleucel
Other Intervention Name(s)
tab-cel®, ATA129, EBV-CTLs
Intervention Description
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Up to 2 years
Title
Duration of response (DOR)
Time Frame
Up to 2 years
Title
Progression-free survival (PFS)
Time Frame
Up to 2 years
Title
For EBV+ PID LPD cohort: Number of participants who reach definitive therapy (ie, allogeneic HCT) for the underlying disease
Time Frame
Up to 2 years
Title
For EBV+ PID LPD cohort: Time to definitive therapy
Time Frame
Up to 2 years
Title
For EBV+ sarcoma cohort, including LMS or smooth muscle tumors: Clinical benefit rate
Time Frame
Up to 2 years
Title
For EBV+ sarcoma cohort, including LMS or smooth muscle tumors: ORR by immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 Cohort-specific Inclusion Criteria: For participants with PID LPD: R/R or newly diagnosed PID LPD for whom the standard first-line therapy is inappropriate, as determined by investigator. The LPD is confirmed by at least biopsy-proven EBV+ LPD or positive cerebrospinal fluid (CSF) cytology with or without radiographically measurable intracranial disease with EBV detected in CSF. Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification (Cheson BD, et al. J Clin Oncol. 2014;27:3059) during or after treatment or failure to achieve a CR or partial response (PR) (defined by Lugano radiographic criteria) after standard first-line therapy Participant may have systemic disease only, systemic and CNS disease, or CNS disease only For participants with AID LPD: R/R or newly diagnosed AID LPD for whom the standard first line therapy is inappropriate, as determined by the investigator. The LPD is confirmed by at least biopsy-proven EBV+ LPD or positive CSF cytology, with or without radiographically measurable intracranial disease, with EBV detected in CSF. Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification during or after treatment or failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy Participant may have systemic disease only, systemic and CNS disease, or CNS disease only For participants with AID etiology or AID attributable to immunosenescence, objective laboratory evidence of immunodeficiency For participants with CNS PTLD: R/R or newly diagnosed EBV+ CNS PTLD for whom the standard first-line therapy is inappropriate, as determined by the investigator. The CNS PTLD is histologically confirmed by at least biopsy-proven EBV+ CNS PTLD or positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF. Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification during or after treatment or failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy Participant may have systemic and CNS disease or CNS disease only For participants with EBV+ PTLD, including CD20-negative disease: Biopsy-proven EBV+ PTLD for whom standard first-line therapy (rituximab and/or chemotherapy) is inappropriate, as determined by the investigator Participants must have systemic disease measurable per Lugano Classification criteria, except when contraindicated or mandated by local practice, then MRI may be used For participants with sarcoma, including LMS, or smooth muscle tumors: EBV+ sarcoma or smooth muscle tumor with rapidly progressive disease defined as progressive disease per RECIST 1.1 criteria as documented radiographically within a 6-month interval prior to enrollment Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, as determined by the investigator Biopsy-proven EBV+ sarcoma meeting one of the criteria's of pathologically confirmed EBV+ Leiomyosarcoma or EBV+ sarcoma or smooth muscle tumor Measurable disease using diagnostic CT and/or MRI following RECIST 1.1 criteria (Eisenhauer et al. 2009. Eur J Cancer 45[2]:228-247) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
650-278-8930
Ext
option 1
Email
clinicalstudies@atarabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Wahlstrom, MD
Organizational Affiliation
Atara Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of California Los Angeles (UCLA) (Adults and Pediatrics)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herbert Eradat, MD
Phone
310-794-6376
Email
heredat@mednet.ucla.edu
Facility Name
Children's Hospital of Orange County (Pediatrics [up to 25 years old])
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilibeth Torno, MD
Phone
714-509-4348
Email
ltorno@choc.org
Facility Name
Lucile Packard Children's Hospital Stanford (Pediatrics only)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianna Marks, MD
Phone
650-497-8953
Email
marksl@stanford.edu
Facility Name
University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehrdad Abedi, MD
Phone
916-734-3772
Email
mabedi@ucdavis.edu
Facility Name
Sylvester Comprehensive Cancer Center/ University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warren Alperstein, MD
Phone
305-243-7925
Email
walperstein@miami.edu
Facility Name
Moffit Cancer Center (Adults only)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Withdrawn
Facility Name
Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanmuganathan Chandrakasan, MD
Phone
404-727-8877
Email
shanmuganathan.chandrakasan@choa.org
Facility Name
Emory University/Winship Cancer Institute (Adults [>= 16 years])
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonali Chaudhury, MD
Phone
312-227-4090
Email
schaudhury@luriechildrens.org
Facility Name
University of Maryland Medical Center (Adults only)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Yared, MD
Phone
410-328-1230
Email
jyared@umm.edu
Facility Name
Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Nikiforow, MD
Phone
617-632-3477
Email
sarah_nikiforow@dfci.harvard.edu
Facility Name
University of Michigan Rogel Cancer Center (Adults and Pediatrics)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monalisa Ghosh, MD
Phone
734-232-4484
Email
ghoshm@med.umich.edu
Facility Name
University of Minnesota (Adults only)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Maakaron, MD
Phone
612-625-6919
Email
maaka001@umn.edu
Facility Name
Washington University in St. Louis (Adults only)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armin Ghobadi, MD
Phone
314-747-2743
Email
arminghobadi@wustl.edu
Facility Name
The Children's Hospital at Montefiore (Adults and Pediatrics)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Loeb, MD
Phone
718-920-4664
Email
david.loeb@einsteinmed.org
Facility Name
Columbia University Irving Medical Center (Adults only)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Curran, MD
Phone
212-639-5836
Email
currank@mskcc.org
Facility Name
Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Baiocchi, MD
Phone
614-915-2084
Email
robert.baiocchi@osumc.edu
Facility Name
Oregon Health and Science University (Adults and Pediatrics)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eneida Nemecek, MD
Phone
503-494-5058
Email
nemeceke@ohsu.edu
Facility Name
Medical University of South Carolina (Adults and Pediatrics)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Hudspeth, MD
Phone
843-792-0381
Email
hudspeth@musc.edu
Facility Name
University of Texas Southwestern Medical Center (Pediatrics only)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Aquino, MD
Phone
214-648-8800
Email
victor.aquino@utsouthwestern.edu
Facility Name
MD Anderson (Adults and Pediatrics)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dristhi Ragoonanan, MD
Phone
713-632-5087
Email
Dragoonanan@mdanderson.org
Facility Name
Medizinische Universität Graz (Adults only)
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hildegard Greinix, MD
Phone
43 3 163 858 4086
Email
hildegard.greinix@medunigraz.at
Facility Name
Uniklinikum Salzburg Landeskrankenhaus (Adults only)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Greil, MD
Phone
43(0) 57 2550
Email
r.greil@salk.at
Facility Name
Medizinische Universität Wien (Adults only)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Worel, MD
Phone
43 01 40 400 5302
Email
nina.worel@meduniwien.ac.at
Facility Name
Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)
City
Bruxelles
State/Province
Brussles
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Devalk, MD
Phone
32 24773113
Email
christine.devalck@huderf.be
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Snauwaert, MD
Phone
32 50-45-21-11
Email
sylvia.snauwaert@azsintjan.be
Facility Name
Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dries Deeran, MD
Phone
32 51 23 76 56
Email
dries.deeren@azdelta.be
Facility Name
Hôpital Saint-Eloi (Adults and Pediatrics)
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Herbaux, MD
Phone
33 4 67 33 67 33
Email
c-herbaux@chu-montpellier.fr
Facility Name
Hôpital Universitaire Pitié Salpêtrière (Adults only)
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain S Choquet, MD
Phone
33 1 42 16 28 26
Email
sylvain.choquet@aphp.fr
Facility Name
Hôpital Necker-Enfants Malades (Adults and Pediatrics)
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Suarez, MD
Phone
33 1 44 49 52 87
Email
felipe.suarez@aphp.fr
Facility Name
Azienda Ospedaliero-Universitaria Pisana (Adults only)
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Orciuolo, MD
Phone
39 05 0993488
Email
e.orciuolo@alumni.sssup.it
Facility Name
Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Locatelli, MD
Phone
39 06 68592129
Email
franco.locatelli@opbg.net
Facility Name
Ospedale Infantile Regina Margherita (Pediatrics only)
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franca Fagioli, MD
Phone
39 01 13135230
Email
franca.fagioli@unito.it
Facility Name
Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Barba Suñol, MD
Phone
34 934893806
Email
pbarba@vhio.net
Facility Name
Hospital Universitario Ramón y Cajal (Adults only)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier López Jiménez, MD
Phone
34 91-336-80-00
Email
jlopezj.hrc@salud.madrid.org
Facility Name
Hospital Universitario Viegen del Rocio (Adults and Pediatrics)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Antonio Perez Simon, MD
Phone
34 9 55 01 31 61
Email
josea.perez.simon.sspa@juntadeandalucia.es
Facility Name
University Hospital Birmingham NHS Foundation Trust (Adults only)
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sridhar Chiganti, MD
Phone
44 012 1 371 4379
Email
sridhar.chaganti@uhb.nhs.uk
Facility Name
Great Ormond Street Hospital (Pediatrics only)
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Persis Amrolia, MD
Phone
44 020 7813 8434
Email
persis.amrolia@gosh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs