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 35 人开始时间: 2015年1月19日最近更新: 2017年1月16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: 35

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

性别: All

入选标准

•FOR SCREENING PHASE:
•1. Diagnosis of extranodal NK/T lymphoma, per WHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
•2. a) Clinically suspected or documented relapse/progression, at any time following at least one cycle of an asparaginase-based chemotherapy OR
•b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) at any time (regardless of chemotherapy status and disease relapse/ progression)*
•3. Male or female = 18 years of age.
•4. Weigh = 35 kg.
•5. ECOG performance score 0-2, inclusively.
•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.
•*Option B is intended to allow for advance manufacture of product in high risk patients to ensure immediate availability at time of relapse.
•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. At least one prior cycle of gemcitabine-based salvage chemotherapy, or alternative salvage regimen if patient has previously been treated with gemcitabine or if there is medical rationale for administration of an alternative salvage regimen.
•4. a) Presence of measurable disease as defined by at least one of the following:
•(i) Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
•(ii) The modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
•(iii) For patients with skin disease, biopsy confirmation of cutaneous NK/T lymphoma.
•(Patients meeting any one of the above criteria will be assigned to Group A), OR
•b) No measurable disease (assigned to Arm B).
•5. Completed most recent course of chemotherapy at least 2 weeks prior to first study drug dose.
•6. 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).
•7. Life expectancy = 8 weeks.
•8. 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. 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 dose of alternative corticosteroid within 10 days prior to obtaining 100 mL 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 (including hemophagocytic lymphohistiocytosis) 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.
•10. Previous non-hematological malignancy, except for adequately treated basal-cell carcinoma of 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 or solid organ transplant.
•FOR TREATMENT PHASE:
•1. All Screening Phase exclusion criteria.
•2. Use of any investigational agents within prior 4 weeks.
•3. Radiotherapy within prior 3 weeks.
•4. Major surgery within prior 2 weeks.
•5. Signs/ symptoms of severe infection within prior 2 weeks.
•6. Systemic corticosteroids within 24 hours prior to study drug administration.
•7. Symptoms of cardiac failure with New York Heart Association classification of III or IV.

研究者

发起方

Cell Medica Inc.

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