肿瘤细胞治疗研究
英文原题：High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项 I 期注册临床试验，评估 T 细胞治疗淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 17 例。试验地点：美国 · 巴斯金里奇、米德尔敦、蒙特维尔、科马克（共 7 个中心）。登记号：NCT01840566。
不限性别 · ≥ 18 Years
适合移植的患者须符合以下标准。纳入标准：年龄≥18岁，患侵袭性B细胞非霍奇金淋巴瘤亚型，包括复发/难治性弥漫大B细胞淋巴瘤（DLBCL）或转化性滤泡性淋巴瘤，并至少符合一项：复发或难治时有骨髓受累且不适合异体移植；或影像显示放疗野外PET阳性病灶，若病变仅位于单一放疗野内且此前接受该野放疗，则须在≥2个周期挽救化疗后仍达到1999年IWG标准的化疗敏感状态。肌酐≤1.5 mg/100 mL，或24小时肌酐清除率≥50 cc/min；胆红素<2.0 mg/100 mL，AST和ALT<正常值上限3倍，稳定慢性抗凝治疗者除外，PT和PTT<正常值2倍；心功能充分（近1个月内超声心动图或MUGA显示LVEF>40%）；肺功能充分（按血红蛋白校正的DLCO≥45%）；预期寿命>3个月。排除标准：Karnofsky体能状态≤70；其他未包含在纳入标准中的侵袭性B细胞恶性肿瘤，如伯基特淋巴瘤、转化性CLL/SLL、转化性边缘区淋巴瘤；既往接受自体或异体骨髓/干细胞移植；其他既往或当前恶性肿瘤（研究者认为不妨碍参加者除外）；未控制的细菌、病毒或真菌感染；HIV、活动性乙肝或丙肝感染。
Transplant eligible patients will be eligible if criteria met per below. Inclusion Criteria: * Patients ≥ 18 years of age with aggressive B-cell non-Hodgkin lymphoma subtypes including, relapsed or refractory diffused large B-cell lymphoma (DLBCL), and transformed follicular lymphoma meeting at least one of the following criteria: * Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation. * PET positive disease outside of one radiation port unless single-port disease treated with prior radiotherapy within the port, following \> or = to 2 cycles of salvage chemotherapy, still achieving chemosensitive status 1999 IWG criteria (section 12.2 and 12.383). * Creatinine ≤ 1.5 mg/100 ml (or measured 24 hour creatinine clearance of ≥ 50 cc/min) * Bilirubin \<2.0 mg/100 ml, AST and ALT \<3x the upper-limit of normal, PT and PTT \< 2x normal outside the setting of stable chronic anticoagulation therapy, * Adequate cardiac function (LVEF\>40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment. * Adequate pulmonary function as assessed by DLCO of \> or = to 45% adjusted for hemoglobin. * Life expectancy of \> 3 months. Exclusion Criteria: * Karnofsky performance status ≤ 70 (see appendix VI). * Patients with other aggressive B-cell malignancies including, but not limited to: Burkitt lymphoma, transformed CLL/SLL and transformed marginal zone lymphoma that are not included in 6.1 inclusion criteria. * Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible. * Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study. * Uncontrolled bacterial, viral or fungal infection. * Patients with HIV, active hepatitis B or hepatitis C infection.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：maximum tolerated dose (MTD) · will be assessed utilizing a standard 3+3 cell dose escalation to determine the maximum tolerated dose of CD19+ CAR T cells · 2 years；safety · Toxicity will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 · 2 years
次要终点：2 year progression-free (PFS)；overall survival (os)
I期剂量递增研究，旨在确定复发/难治性侵袭性B细胞非霍奇金淋巴瘤患者CAR修饰T细胞的最大耐受剂量。计划评估三个剂量水平：5×10^6、1×10^7及2×10^7个19-28z T细胞/kg。
本研究旨在检验大剂量化疗（HDT）和自体干细胞移植（ASCT）后输注患者自身免疫细胞（T细胞）的安全性。
The purpose of this study is to test the safety of delivering the patients' own immune cells, called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT).
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