肿瘤细胞治疗研究
英文原题：To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
⚠ 该试验的登记信息已有 22 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 II 期注册临床试验，评估 CAR-T 细胞治疗非霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 20 例。试验地点：亚太其他 · 敦拉萨镇（共 1 个中心）。登记号：NCT06698484。
不限性别 · ≥ 13 Years 且 ≤ 75 Years
纳入标准：按WHO分类经组织学确诊CD19阳性B细胞非霍奇金淋巴瘤；二线治疗难治，或一线治疗后复发且无自体/异体造血干细胞移植等可用治愈性治疗方案，或自体移植后1年内复发；至少一个符合修订IWG缓解标准的可测量病灶；年龄≥13岁且≤75岁；器官功能充分（肌酐清除率>40 mL/min，ALT<正常值上限5倍，胆红素<正常值上限3倍，左心室射血分数>45%）；中性粒细胞绝对计数≥1500/μL，血红蛋白≥7 g/dL，血小板≥50000/μL；预期寿命>12周；ECOG≤2分；有生育可能的女性妊娠试验阴性且采用两种有效避孕方式；男性采用两种有效避孕方式。排除标准：活动性中枢神经系统淋巴瘤（影像或脑脊液检查发现）；活动性非NHL癌症或正在接受癌症治疗；严重肺、心脏（纽约心脏协会III/IV级、心律失常、心脏传导阻滞、未控制高血压）、肝或肾功能衰竭，或严重神经系统疾病；需免疫抑制治疗的活动性自身免疫病；HIV阳性；活动性乙肝或丙肝感染；未控制感染；妊娠或哺乳；入组前12周内接受自体或异体干细胞移植。
Inclusion Criteria: * Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification * Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT * At least one measurable lesion according to revised IWG response criteria * Age between ≥13to ≤75 years * Adequate organ function as defined by a creatinine clearance \>40 ml/min, serum alanine transaminase (ALT) \< 5 times the normal value, serum bilirubin \< 3 times the normal value, left ventricular ejection fraction\> 45% * Absolute neutrophil count ≥ 1500/μl, haemoglobin level ≥ 7 g/dl, platelets ≥ 50000/μl. * Life expectancy \>12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Female of childbearing age must have a negative pregnancy test and is on two effective contraception methods * Male patients must use two effective contraception methods Exclusion Criteria: * Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis) * Active cancer(other than NHL) or receiving cancer treatment * Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder * Presence of active autoimmune disease requiring immunosuppressive therapy * Human Immunodeficiency Virus (HIV) positivity * Active Hepatitis B, and Hepatitis C infection * Uncontrolled infection * Pregnant/nursing female. * Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrolment
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：Overall response rate (ORR) · The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL).
Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study. · From day 30, then 3 monthly until 24 months after infusion of CAR-T cells
次要终点：overall survival；Incidence of adverse events
CD19 CAR-T细胞。
II期、开放标签、单臂研究，评估本地制备的自体CD19定向CAR-T细胞治疗复发/难治性B细胞非霍奇金淋巴瘤（B-NHL）患者或不适合接受造血干细胞移植（HCT）患者的安全性和疗效。
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)
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