A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
NCT ID: NCT04554914
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
190 participants
INTERVENTIONAL
2021-07-14
2028-05-31
Brief Summary
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Detailed Description
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* 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 \[cohort closed for enrollment after completion of stage1\]
* EBV+ post-transplant 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 which occurs at 12 (± 1) months after Cycle 1 Day 1 for adults, and 24 (± 1) months after Cycle 1 Day 1 for pediatric participants. 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 relevant 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EBV+ PID LPD
Participants with R/R or newly diagnosed EBV+ PID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
Tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
EBV+ AID LPD
Participants with R/R or newly diagnosed EBV+ AID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
Cohort closed for enrollment after completion of stage1
Tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
EBV+ CNS PTLD
Participants with R/R or newly diagnosed EBV+ CNS PTLD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
Tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
EBV+ 1L PTLD (inappropriate for first-line therapy or CD20-negative)
Participants with EBV+ PTLD for whom standard first-line therapy (rituximab or chemotherapy) is inappropriate, including CD20-negative disease, will receive IV tabelecleucel.
Tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
EBV+ sarcoma, including LMS, or smooth muscle tumors
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.
Tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Interventions
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Tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* Inability or unwillingness to comply with all study procedures.
* 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).
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Anke Friedetzky
Role: STUDY_DIRECTOR
Pierre Fabre Laboratories
Locations
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University of California Los Angeles (UCLA) (Adults and Pediatrics)
Los Angeles, California, United States
Children's Hospital of Orange County (Pediatrics [up to 25 years old])
Orange, California, United States
Lucile Packard Children's Hospital Stanford (Pediatrics only)
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)
Sacramento, California, United States
Sylvester Comprehensive Cancer Center/ University of Miami
Miami, Florida, United States
Moffit Cancer Center (Adults only)
Tampa, Florida, United States
Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])
Atlanta, Georgia, United States
Emory University/Winship Cancer Institute (Adults [>= 16 years])
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)
Chicago, Illinois, United States
University of Maryland Medical Center (Adults only)
Baltimore, Maryland, United States
Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)
Boston, Massachusetts, United States
University of Michigan Rogel Cancer Center (Adults and Pediatrics)
Ann Arbor, Michigan, United States
University of Minnesota (Adults only)
Minneapolis, Minnesota, United States
Washington University in St. Louis (Adults only)
St Louis, Missouri, United States
Columbia University Irving Medical Center (Adults only)
New York, New York, United States
Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)
New York, New York, United States
The Children's Hospital at Montefiore (Adults and Pediatrics)
The Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)
Cleveland, Ohio, United States
The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)
Columbus, Ohio, United States
Oregon Health and Science University (Adults and Pediatrics)
Portland, Oregon, United States
Medical University of South Carolina (Adults and Pediatrics)
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center (Pediatrics only)
Dallas, Texas, United States
MD Anderson (Adults and Pediatrics)
Houston, Texas, United States
Uniklinikum Salzburg Landeskrankenhaus (Adults only)
Salzburg, Salzburg, Austria
Medizinische Universität Graz (Adults only)
Graz, Styria, Austria
Medizinische Universität Wien (Adults only)
Vienna, Vienna, Austria
Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)
Brussels, Brussles, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)
Bruges, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)
Roeselare, West-Vlaanderen, Belgium
Hôpital Saint-Eloi (Adults and Pediatrics)
Montpellier, Montpellier, France
Hôpital Necker-Enfants Malades (Adults and Pediatrics)
Paris, Paris, France
Hôpital Universitaire Pitié Salpêtrière (Adults only)
Paris, , France
Azienda Ospedaliero-Universitaria Pisana (Adults only)
Pisa, Pisa, Italy
Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)
Roma, Roma, Italy
Ospedale Infantile Regina Margherita (Pediatrics only)
Torino, Torino, Italy
Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)
Barcelona, Barcelona, Spain
Hospital Universitario Ramón y Cajal (Adults only)
Madrid, Madrid, Spain
Hospital Universitario Virgen del Rocio (Adults and Pediatrics)
Seville, Sevilla, Spain
University Hospital Birmingham NHS Foundation Trust (Adults only)
Birmingham, England, United Kingdom
Great Ormond Street Hospital (Pediatrics only)
London, England, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Lilibeth Torno, MD
Role: primary
Lianna Marks, MD
Role: primary
Warren Alperstein, MD
Role: primary
Shanmuganathan Chandrakasan, MD
Role: primary
Sonali Chaudhury, MD
Role: primary
Sarah Nikiforow, MD
Role: primary
Monalisa Ghosh, MD
Role: primary
Supriya Gupta, MD
Role: primary
Armin Ghobadi, MD
Role: primary
David Loeb, MD
Role: primary
Robert Baiocchi, MD
Role: primary
Andy Chen, MD
Role: primary
Victor Aquino, MD
Role: primary
Priti Tewari, MD
Role: primary
Nina Worel, MD
Role: primary
Christine Devalck, MD
Role: primary
Sylvia Snauwaert, MD
Role: primary
Dries Deeran, MD
Role: primary
Charles Herbaux, MD
Role: primary
Felipe Suarez, MD
Role: primary
Sylvain S Choquet, MD
Role: primary
Enrico Orciuolo, MD
Role: primary
Franco Locatelli, MD
Role: primary
Franca Fagioli, MD
Role: primary
Pere Barba Suñol, MD
Role: primary
Javier López Jiménez, MD
Role: primary
Jose Antonio Perez Simon, MD
Role: primary
Sridhar Chaganti, MD
Role: primary
Persis Amrolia, MD
Role: primary
Other Identifiers
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2024-516623-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
ATA129-EBV-205/F60085DL205
Identifier Type: -
Identifier Source: org_study_id
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