A Phase 2 open label study to investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive extranodal NK/T-cell lymphoma (ENKTCL). - CITADEL - Cellular Immunotherapy Treatment Antigen-directed for EBV Lymphoma

Cell Medica Inc.0 个研究点目标入组 15 人开始时间: 2015年1月12日最近更新: 2019年2月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•FOR SCREENING PHASE:
•1. Diagnosis of extranodal NK/T lymphoma, per WHO classification, which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
•2. a) Active Disease:
•(1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR
•2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR
•b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy (Appendix B)
•3. Male or female = 18 years of age.
•4. Weigh = 35 kg.
•5. ECOG performance score 0-2, inclusively (Appendix A).
•6. Negative ß-hCG test in women of childbearing potential.
•7. Able to understand and comply with the requirements of the study and to provide written informed consent.
•8. Estimated life expectancy greater than four months.
•FOR TREATMENT PHASE:
•1. All Screening Phase inclusion criteria.
•2. Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
•3. Active disease based on any one of the following present at the baseline study visit or within two weeks prior to the baseline study visit:
•a. Imaging (may use local imaging)
•b. Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical signs.
•c. Detectable blood or plasma EBV DNA (may use local laboratory)
•4. Completed most recent course of chemotherapy at least 2 weeks prior to first study product dose.
•5. Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by = Grade 1 according to NCI CTCAE v4.0. (Transfusion to achieve the hematological criteria is acceptable.)
•6. Pulse oximetry of = 90% on room air.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•FOR SCREENING PHASE:
•1. Known central nervous system (CNS) lymphoma.
•2. NK/T cell leukemia.
•3. Known hypersensitivity to the investigational product or any components in the final formulation (e.g. DMSO and/or HSA).
•4. Positive laboratory test for anti-HIV 1, 2; HBsAg, anti-HTLV-I; anti-HCV, or syphilis (Patients with anti-hepatitis B core antibody are eligible if negative for HBsAg).
•5. Use of systemic corticosteroids >0.5 mg/kg/day prednisolone or equivalent alternative corticosteroid within 10 days prior to obtaining 200 mL whole blood starting material.
•6. Patient is pregnant or lactating.
•7. Female patients of childbearing potential and male patients with partners of childbearing potential unwilling to use a highly effective method of birth control during the study and for 6 months after the study treatment is concluded.
•8. Clinically significant medical condition e.g. pulmonary, neurological, cardiovascular, metabolic, or hematologic that could jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.
•9. Active second malignancy, except for localized basal cell carcinoma of skin, squamous cell carcinoma of the skin or cervical carcinoma in situ.
•10. Previous non-hematological malignancy, except for adequately treated basal-cell carcinoma of skin, a squamous cell carcinoma of the skin or cervical carcinoma in situ without current evidence of disease, unless the tumor was treated with curative intent more than 5 years prior to study entry.
•11. Any prior allogeneic hematopoietic stem cell.
•12. Any prior solid organ transplant.
•13. Asparaginase-refractory disease, defined by any one of the following:
•a. Progression at any time during initial asparaginase-based chemotherapy and up to 3 months after end of initial asparaginase-based chemotherapy regimen; OR
•b. Failure to achieve at least PR with initial asparaginase-based chemotherapy, OR
•c. Persistence of significant (score 4 or 5) residual FDG-avid metabolic activity using the quantitative 5-point Deauville score following initial asparaginase based chemotherapy regimen.
•14. Absolute lymphocyte count (ALC) <400/µL.
•15. Any previous autologous EBV specific T cell treatment.
•16. History of any one of the following cardiovascular conditions within the past 3 months:
•a. Class III or IV heart failure as defined by the New York Heart Association.
•b. Cardiac angioplasty or stenting
•c. Documented myocardial infarction, or
•d. Unstable angina.
•17. Systemic fungal, bacterial, viral or other infection that is not controlled
•18. Third or greater relapse
•FOR TREATMENT PHASE:
•1. All Screening Phase exclusion criteria with following exception:
•a. ALC < 400/µL.
•2. Use of any investigational agents within prior 4 weeks.
•3. Radiotherapy within prior 3 weeks.
•4. Major surgery within prior 2 weeks.

研究者

发起方

Cell Medica Inc.

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