Clinical Trials in the USA / NCT04554914
Active, not recruiting
Phase 2
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
NCT04554914 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Epstein-Barr Virus (EBV)-Associated DiseasesEBV+ 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 ComplicationsLymphoproliferative DisordersAllogeneic Hematopoietic Cell TransplantStem Cell Transplant ComplicationsEBV+ SarcomasLeiomyosarcoma
Investigational drug(s) / intervention(s)
Tabelecleucel: Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Study summary
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
Eligibility
Inclusion Criteria:
* Diagnosis of EBV+ disease.
* 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 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:
* 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.
* 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).
Primary outcome measure(s)
- Objective response rate (ORR) — Up to 2 years
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Los Angeles (UCLA) (Adults and Pediatrics) | Los Angeles | California | |
| Children's Hospital of Orange County (Pediatrics [up to 25 years old]) | Orange | California | |
| Lucile Packard Children's Hospital Stanford (Pediatrics only) | Palo Alto | California | |
| University of California Davis Comprehensive Cancer Center (Adults and Pediatrics) | Sacramento | California | |
| Sylvester Comprehensive Cancer Center/ University of Miami | Miami | Florida | |
| Moffit Cancer Center (Adults only) | Tampa | Florida | |
| Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old]) | Atlanta | Georgia | |
| Emory University/Winship Cancer Institute (Adults [>= 16 years]) | Atlanta | Georgia | |
| Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only) | Chicago | Illinois | |
| University of Maryland Medical Center (Adults only) | Baltimore | Maryland | |
| Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics) | Boston | Massachusetts | |
| University of Michigan Rogel Cancer Center (Adults and Pediatrics) | Ann Arbor | Michigan | |
| University of Minnesota (Adults only) | Minneapolis | Minnesota | |
| Washington University in St. Louis (Adults only) | St Louis | Missouri | |
| Columbia University Irving Medical Center (Adults only) | New York | New York | |
| Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics) | New York | New York | |
| The Children's Hospital at Montefiore (Adults and Pediatrics) | The Bronx | New York | |
| Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics) | Cleveland | Ohio | |
| The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only) | Columbus | Ohio | |
| Oregon Health and Science University (Adults and Pediatrics) | Portland | Oregon | |
| Medical University of South Carolina (Adults and Pediatrics) | Charleston | South Carolina | |
| University of Texas Southwestern Medical Center (Pediatrics only) | Dallas | Texas | |
| MD Anderson (Adults and Pediatrics) | Houston | Texas | |
| Uniklinikum Salzburg Landeskrankenhaus (Adults only) | Salzburg | State of Salzburg | |
| Medizinische Universität Wien (Adults only) | Vienna | State of Vienna | |
| Medizinische Universität Graz (Adults only) | Graz | Styria | |
| Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only) | Brussels | Brussles | |
| Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only) | Bruges | West-Vlaanderen | |
| Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only) | Roeselare | West-Vlaanderen | |
| Hôpital Saint-Eloi (Adults and Pediatrics) | Montpellier | Montpellier | |
| Hôpital Necker-Enfants Malades (Adults and Pediatrics) | Paris | Paris | |
| Hôpital Universitaire Pitié Salpêtrière (Adults only) | Paris | France | |
| Azienda Ospedaliero-Universitaria Pisana (Adults only) | Pisa | Pisa | |
| Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics) | Roma | Roma | |
| Ospedale Infantile Regina Margherita (Pediatrics only) | Torino | Torino | |
| Hospital Universitari Vall d'Hebrón (Adults and Pediatrics) | Barcelona | Barcelona | |
| Hospital Universitario Ramón y Cajal (Adults only) | Madrid | Madrid | |
| Hospital Universitario Virgen del Rocio (Adults and Pediatrics) | Seville | Sevilla | |
| University Hospital Birmingham NHS Foundation Trust (Adults only) | Birmingham | England | |
| Great Ormond Street Hospital (Pediatrics only) | London | England |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04554914 on ClinicalTrials.gov ↗ ← All trials in the USA