EUCTR2020-000177-25-BE进行中（未招募）1 期
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)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. ECOG performance status =3 for subjects aged =16 years; Lansky score =20 for subjects from =1 year to <16 years
- •2. Adequate organ function, unless organ dysfunction is considered to be due to the underlying EBV-associated disease
- •3. Males and females of any age
- •For subjects with PID LPD
- •4. Provided written informed consent and assent, if required by law for pediatric subjects in accordance with the requirements
- •5.Relapsed and/or refractory (R/R) or newly diagnosed PID LPD for whom the standard first line therapy is inappropriate, as determined by the investigator
- •LPD confirmed by at least 1 of the following:
- •a. Biopsy-proven EBV+ LPD
- •b. Positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF
- •Subjects with R/R disease must have had at least one prior line of systemic therapy and one of the following:
- •a.Radiographic disease progression per Lugano Classification during or after treatment
- •b.Failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy
- •6.Subjects may have systemic disease only, systemic and CNS disease or CNS disease only, meeting one of the following criteria:
- •a.Systemic disease measurable per Lugano Classification criteria, by PET-CT as evidenced by 18F-deoxyglucose avidity, except when contraindicated or mandated by local practice, then MRI may be used.
- •b.CNS only disease measurable by MRI, CT, or by cytology and flow cytometry with EBV detected in CSF
- •For subjects with AID LPD
- •7.R/R or newly diagnosed AID LPD for whom the standard first line therapy is inappropriate, as determined by the investigator, confirmed by at least 1 of the following criteria:
- •a.Biopsy-proven EBV+ LPD
- •b.Positive CSF cytology, with or without radiographically measurable intracranial disease, with EBV detected in CSF
- •Subjects with R/R disease must have had at least one prior line of systemic therapy and one of the following:
- •a.Radiographic disease progression per Lugano Classification during or after treatment
- •b.Failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy
- •8.Subjects may have systemic disease only, systemic and CNS disease or CNS disease only, meeting one of the following criteria:
- •a. Systemic disease measurable per Lugano Classification criteria, by PET-diagnostic CT as evidenced by 18F-deoxyglucose avidity
- •b. CNS only disease measurable by MRI, CT, or by cytology and flow cytometry with EBV detected in CSF
- •9. For subjects with AID of idiopathic etiology or AID attributable to immunosenescence, objective laboratory evidence of immunodeficiency (e.g., lymphopenia, hypogammaglobulinemia).
- •For subjects with CNS PTLD
- •10.R/R or newly diagnosed CNS PTLD for whom the standard first line therapy is inappropriate, as determined by the investigator, confirmed by at least 1 of the following:
- •a.Biopsy-proven EBV+ CNS PTLD
- •b.Positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF
- •Subjects with R/R disease must have had at least one prior line of systemic therapy and one of the following:
- •a.Radiographic disease progression per Lugano Classification during or after treatment
- •b.Failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy
- •11.Subjects may have systemic and CNS disease, or CNS disease only meeting the following criteria:
- •a.When present, systemic disease measurable per Lugano Clas
排除标准
- •1. Currently active Burkitt, T cell, NK/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
- •2. Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment, or known history of HIV infection
- •3. Suspected or confirmed grade = 2 acute (GvHD) per the CIBMTR consensus grading system or moderate/severe chronic GvHD per NIH consensus criteria at the time of the enrollment
- •4. Need for vasopressor or ventilatory support at the time of enrollment
- •5. Prior therapy (in order of increasing washout period) prior to enrollment, as follows:
- •a. Within 4 weeks or 5 half-lives (whichever is shorter):
- •i. Any investigational product (co-enrollment in a non-interventional study or a study for sample collection only is permitted)
- •ii. 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.
- •b. Within 8 weeks:
- •i. Prior tabelecleucel (>8 weeks prior to enrollment) is permitted (in consultation with the Medical Monitor) if response was obtained or if usual protocol-directed therapeutic options were not exhausted (e.g., restriction switch options)
- •ii. Cellular therapies: chimeric antigen receptor (CAR) therapies directed at T cells or T cell subsets, donor lymphocyte infusion, other CTLs, or virus-specific T cells
- •iii. Therapies which could impact tabelecleucel function: Anti-thymocyte globulin, alemtuzumab
- •c. any prior treatment with EBV-CTLs with the exception of tabelecleucel as above
- •6.Female who is breastfeeding or pregnant
- •7.Any of the following while undergoing treatment with tabelecleucel
- •and for 90 days after the last dose (details are specified in the body of
- •the protocol):
- •For females of childbearing potential: 1) unwilling to use a highly effective method of contraception (i.e., one that can achieve a failure rate of less than 1% per year when used consistently and correctly) or 2) unwilling to refrain from donating eggs
- •For males: 1) unwilling to use a condom during sexual intercourse or 2) unwilling to refrain from donating sperm or 3) has a female partner of childbearing potential who is unwilling to use a highly effective method of contraception (refer to protocol Section 5.6.4)
- •8. Inability or unwillingness to comply with all study procedures
- •9. Ongoing need for daily steroids of >0.5 mg/kg prednisone or glucocorticoid equivalent ongoing methotrexate, or extracorporeal photopheresis. For subjects with CNS disease, protocol specified dexamethasone is permitted
- •10.Any conditions that may put the study outcomes at undue risk:
- •a.Life expectancy < 60 days
- •b.Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
- •11. History of prior allogeneic HCT or SOT
- •12. Prior systemic therapy for PTLD
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