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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)
Phase
Phase 2
Sponsor
Pierre Fabre Medicament
Enrollment
190
Timeline
Jul 2021 → May 2028
About This Study
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
Eligibility Criteria
Inclusion Criteria
- 1Diagnosis of EBV+ disorder.
- 2Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants from ≥ 1 year to \< 16 years.
- 3Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.
- 4For participants with PID LPD:
- 5R/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.
- 6Participants 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 complete response (CR) or partial response (PR) (defined by Lugano radiographic criteria) after standard first-line therapy.
- 7Participant may have systemic disease only, systemic and CNS disease, or CNS disease only.
- 8For participants with AID LPD:
- 9R/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.
- 10Participants 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.
- 11Participant may have systemic disease only, systemic and CNS disease, or CNS disease only.
- 12For participants with AID etiology or AID attributable to immunosenescence, objective laboratory evidence of immunodeficiency.
- 13For participants with CNS PTLD:
- 14R/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.
- 15Participants 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.
- 16Participant may have systemic and CNS disease or CNS disease only.
- 17For participants with EBV+ 1L PTLD, including CD20-negative disease:
- 18Biopsy-proven EBV+ PTLD for whom standard first-line therapy (rituximab and/or chemotherapy) is inappropriate, as determined by the investigator.
- 19Participants must have systemic disease measurable per Lugano Classification criteria, except when contraindicated or mandated by local practice, then MRI may be used.
- 20For participants with sarcoma, including LMS, or smooth muscle tumors:
- 21EBV+ 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.
- 22Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, as determined by the investigator.
- 23Biopsy-proven EBV+ sarcoma meeting one of the criteria's of pathologically confirmed EBV+ Leiomyosarcoma or EBV+ sarcoma or smooth muscle tumor.
- 24Measurable 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
- 1Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.
- 2Serious 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.
- 3Suspected 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.
- 4Need for vasopressor or ventilatory support at the time of enrollment.
- 5Prior therapy (in order of increasing washout period) prior to enrollment as follows:
- 6Within 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.
- 7Within 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).
- 8Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above
- 9Women who are breastfeeding or pregnant.
- 10Unwilling to comply with protocol specified contraceptive/reproductive restrictions from enrollment through 90 days after the last treatment.
- 11Ongoing 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).
- 12Any 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).
- 13For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant.
- 14For participants with EBV+ 1L PTLD: prior systemic therapy for PTLD.
Locations
40 sites participating in this study
Emory University/Winship Cancer Institute (Adults [>= 16 years])
Atlanta, Georgia 30322
University of California Los Angeles (UCLA) (Adults and Pediatrics)
Los Angeles, California 90095
Children's Hospital of Orange County (Pediatrics [up to 25 years old])
Orange, California 92868
Lilibeth Torno, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →