肿瘤细胞治疗研究
英文原题：CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
⚠ 该试验的登记信息已有 72 个月未更新， 页面上显示的「尚未开始招募」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。
这是一项早期 I 期注册临床试验，评估 CAR-T 细胞治疗急性淋巴细胞白血病、淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 72 例。试验地点：中国 · 杭州（共 1 个中心，其中中国 1 个）。登记号：NCT04609241。
不限性别
纳入标准： 仅适用于B-ALL： 1. 性别和年龄不限。 2. 按美国国家综合癌症网络（NCCN）《急性髓系白血病临床实践指南》（2016.v1）组织学确诊CD69b阳性B-ALL。 3. 复发或难治性CD123阳性AML，符合以下任一项：标准化化疗后未达到完全缓解（CR）；首次诱导治疗后达到CR，但缓解持续时间<12个月；首次或多次挽救治疗无效；复发≥2次。 4. 骨髓原始细胞比例>5%（形态学）和/或>0.01%（流式细胞术）。 5. 费城染色体阴性（Ph−）；Ph+患者须不能耐受TKI，或对两种TKI治疗均无应答。 仅适用于B-NHL： 1. 性别和年龄不限。 2. 按WHO淋巴瘤分类标准（2016）组织学确诊为DLBCL（NOS）、滤泡性淋巴瘤、由CLL/SLL转化的DLBCL、原发性纵隔大B细胞淋巴瘤或高级别B细胞淋巴瘤。 3. 复发或难治性B-NHL，符合以下任一项：二线或更高线化疗后无应答或复发；原发耐药；自体造血干细胞移植后复发；或至少有一个符合2014年Lugano标准的可评估肿瘤病灶。 B-ALL和B-NHL患者均须符合： 1. 总胆红素≤51 μmol/L，ALT和AST≤正常值上限的3倍，肌酐≤176.8 μmol/L。 2. 超声心动图显示左心室射血分数（LVEF）≥50%。 3. 无活动性肺部感染，室内空气下血氧饱和度≥92%。 4. 预计生存期≥3个月。 5. ECOG体能状态评分0–2。 6. 患者或其法定监护人自愿参加研究并签署知情同意书。 排除标准： 1. 有颅脑创伤、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. 妊娠或哺乳期。 4. 存在严重活动性感染（单纯尿路感染和细菌性咽炎除外）。 5. 活动性乙型或丙型肝炎病毒感染。 6. 既往接受过任何CAR-T产品或其他基因修饰T细胞治疗。 7. 对CD3/CD28共刺激信号的扩增能力不足（<5倍）。 8. 肌酐>2.5 mg/dL，或ALT/AST>正常值的3倍，或胆红素>2.0 mg/dL。 9. 存在其他不适合参加本试验的未控制疾病。 10. HIV感染。 11. 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:
* Only For B-ALL
1. No gender or age limit
2. Histologically confirmed diagnosis of CD69b+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
3. Relapsed or refractory CD123+ AML (meeting one of the following conditions):
1. CR not achieved after standardized chemotherapy;
2. CR achieved following the first induction, but CR duration is less than 12 months;
3. Ineffectively after first or multiple remedial treatments;
4. 2 or more relapses;
4. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
5. Philadelphia chromosome negative(Ph-) subjects; Ph+ subjects who cannot tolerate tyrosine kinase inhibitor (TKI) treatment or who do not respond to two kinds of TKI treatment;
* Only For B-NHL
1. No gender or age limit;
2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
3. Relapsed or refractory B-NHL (meeting one of the following conditions):
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1. No response or relapse after second-line or above chemotherapy regimens;
2. Primary drug resistance;
3. Relapse after auto-HSCT;
4. At least one assessable tumor lesion per Lugano 2014 criteria
* For both B-ALL and B-NHL
1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
3. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
4. Estimated survival time ≥ 3 months;
5. ECOG performance status 0 to 2;
6. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
Exclusion Criteria:
* 1\. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 7. Insufficient amplification capacity in response to CD3 / CD28 co-stimulus signal (\<5 times) 8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk ofpatients 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：Dose-limiting toxicity (DLT) · Adverse events assessed according to NCI-CTCAE v5.0 criteria · Baseline up to 28 days after CD79b targeted CAR T-cells infusion；Incidence of treatment-emergent adverse events (TEAEs) · Incidence of treatment-emergent adverse events \[Safety and Tolerability\] · Up to 2 years after CD79b targeted CAR T-cells infusion
次要终点：Acute Lymphoblastic Leukemia (ALL), Overall response rate (ORR)；ALL, Overall survival（OS）；ALL, Event-free survival (EFS)；B-cell Non-Hodgkin's Lymphoma（B-NHL）, Overall response rate (ORR)；B-NHL, Overall survival（OS）；B-NHL, Event-free survival (EFS)；Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)；Activities of Daily Living (ADL) score
本研究评估CD79b CAR-T细胞疗法用于复发和/或难治性急性淋巴细胞白血病及B细胞非霍奇金淋巴瘤患者。
A study of CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
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