EUCTR2020-000177-25-FR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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
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. Newly diagnosed or relapsed/refractory 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
- •6. Systemic and/or CNS disease must be measurable by the at least 1 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 disease measurable by MRI, CT, or by positive cytology with EBV detected in CSF
- •7. Definitive therapy for the underlying PID is planned
- •8. Subjects with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD
- •For Subjects with AID LPD
- •9. Newly diagnosed or relapsed/refractory LPD 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
- •10. Systemic and/or CNS disease must be measurable by at least 1 of the following criteria:
- •a. Systemic disease measurable per Lugano Classification criteria, by PET-diagnostic CT as evidenced by 18F-deoxyglucose avidity
- •b. CNS disease measurable by MRI, CT, or by positive cytology with EBV detected in CSF
- •11. Subjects who are HIV+ must meet both of the following criteria:
- •a. An HIV viral load assessed by RT-PCR below the lower limit of detection, according to the institutional standard, within 6 months of the first dose of tabelecleucel
- •b. CD4 = 50 cells/µL within 6 months prior to the first dose of tabelecleucel
- •12. Subjects with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD
- •For Subjects with CNS PTLD
- •13. Newly diagnosed or relapsed/refractory EBV+ CNS PTLD 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
- •14. Subject may have systemic and CNS disease, or CNS disease only meeting the following criteria:
- •a. When present, systemic disease measurable per Lugano Classification criteria, by PET-diagnostic CT as evidenced by 18F-deoxyglucose avidity, except when contraindicated or mandated by local practice, then MRI may be used.
- •b. CNS disease must be measurable by MRI, CT, or by positive cytology with EBV detected in CSF
- •15. Subjects with newly diagnosed disease should be ineligible for standard first-line therapy for EBV+ LPD
- •For subjects with EBV+ PTLD, where standard first line therapy (rituximab and/or chemotherapy) is not appropriate, including CD20-negative disease
- •16. Newly diagnosed, biopsy-proven EBV+ PTLD
- •17. Ineligible for standard first-line therapy for EBV+ PTLD
- •18. Subjects must have systemic disease measurable per Lugano Classification criteria, by PET-diagnostic CT as evidenced by 18F-deoxyglucose avidity
- •For Subjects with Sarcoma, Including LMS
- •19. Newly diagnosed or fail
排除标准
- •1. Burkitt, T cell (except in the setting of HLH), NK/T-cell lymphoma/LPD, Hodgkin, or transformed lymphoma
- •2. Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment
- •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. =8 weeks:
- •i. Cellular therapies: EBV-CTLs, chimeric antigen receptor (CAR) therapies directed at T cells or T cell subsets, donor lymphocyte infusion, other CTLs
- •ii. Therapies which could impact tabelecleucel function: Anti-thymocyte globulin, alemtuzumab
- •6. Female who is breastfeeding or pregnant, or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
- •7. Inability or unwillingness to comply with all study procedures
- •8. 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
- •9 History of prior allogeneic HCT or SOT
研究者
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