肿瘤细胞治疗研究
英文原题：CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
这是一项 II 期注册临床试验，评估 CD19CAR-T 细胞治疗大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 40 例。试验地点：中国 · 杭州（共 1 个中心，其中中国 1 个）。登记号：NCT04661020。
不限性别 · ≥ 18 Years
纳入标准： 1. 年龄≥18岁，性别不限。 2. 新诊断高危大B细胞淋巴瘤，定义为：①诊断时国际预后指数（IPI）评分≥3的弥漫性大B细胞淋巴瘤（DLBCL，非特指型）；②存在MYC及BCL2和/或BCL6基因重排的高级别B细胞淋巴瘤（HGBL）；③非特指型HGBL。 3. 淋巴瘤细胞经确认表达CD19和CD20。 4. ECOG评分0至2。 5. 总胆红素≤51 μmol/L，ALT和AST≤正常值上限的3倍，肌酐≤176.8 μmol/L。 6. 超声心动图显示左心室射血分数（LVEF）≥50%。 7. 肺部无活动性感染，室内空气下血氧饱和度≥92%。 8. 预期生存期≥3个月。 9. 患者或其法定监护人自愿参加并签署知情同意书。 排除标准： 1. 淋巴瘤累及中枢神经系统；有颅脑外伤、意识障碍、癫痫、脑血管缺血性或出血性疾病史。 2. 心电图显示QT间期延长，或既往有严重心脏病（如严重心律失常）。 3. 存在严重活动性感染（单纯尿路感染和细菌性咽炎除外）。 4. 活动性乙型或丙型肝炎病毒感染。 5. 既往接受过任何CAR-T产品或其他基因修饰T细胞疗法。 6. 对CD3/CD28共刺激信号的扩增能力不足（<5倍）。 7. 存在其他不适合参加本试验的未控制疾病。 8. HIV感染。 9. 研究者认为可能增加患者风险或干扰研究结果的任何情况。
Inclusion Criteria: 1. Age no less than 18, no gender limit; 2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified; 3. Confirmed CD19 and CD20 postive expressions in lymphoma cells 4. ECOG score 0-2; 5. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; 8. Estimated survival time ≥ 3 months; 9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: 1. Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 4. Active infection of hepatitis B virus or hepatitis C virus; 5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 6. Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ; 7. Other uncontrolled diseases that were not suitable for this trial; 8. Patients with HIV infection; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
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：Complete remission rate after CD19 CAR-T cell therapy · Assessment of complete remission rate at 3 months after CD19 CAR-T cell therapy · 3 months after CD19 CAR-T cell therapy
次要终点：Overall response rate (ORR)；Overall survival (OS)；Progression-free survival (PFS)；Duration of response (DOR)；Incidence of treatment-emergent adverse events (TEAEs)
本研究评估CD19 CAR-T疗法用于新诊断高危大B细胞淋巴瘤患者的治疗。
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
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