肿瘤细胞治疗研究
英文原题：Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
⚠ 该试验的登记信息已有 16 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/III 期注册临床试验，评估 CD19CAR-T 细胞治疗急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 10 例。试验地点：亚太其他 · 敦拉萨镇（共 1 个中心）。登记号：NCT03937544。
不限性别 · ≥ 13 Years 且 ≤ 65 Years
纳入标准：依据骨髓形态学、流式细胞术、细胞遗传学和分子遗传学检查，按WHO分类确诊复发/难治性B-ALL；年龄≥13岁且≤65岁；脑脊液无可检测白血病细胞（CNS-1）；无临床明显神经症状的CNS白血病（CNS-2：白细胞<5个/μL且细胞学检查原始细胞阳性）；器官功能充分：肌酐清除率>50 mL/min、血清总胆红素<正常值上限5倍、左心室射血分数>40%；ECOG≤2分；预期寿命>3个月；异体HSCT后须≥第+100天、无活动性GVHD且未接受免疫抑制治疗；有生育能力的女性妊娠试验阴性并采取高效避孕措施；男性采取高效避孕措施。排除标准：CNS-3白血病；合并B-ALL以外的活动性癌症；严重肺、心脏（NYHA III/IV级、心律失常、房室传导阻滞、未控制高血压）、肝或肾功能衰竭，或严重神经系统疾病；活动性自身免疫病或特应性过敏；HIV血清学阳性；定量病毒PCR提示活动性乙肝或丙肝感染；未控制的败血症；妊娠或哺乳；持续使用泼尼松龙>1 mg/kg/日或等效剂量；最近4周内接受化疗/免疫治疗（如异体细胞治疗或抗GVHD治疗）。
Inclusion Criteria: * Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics * Age between ≥13 to ≤ 65 years * No detectable leukaemia in the CSF (CNS-1) * CNS leukaemia without clinically evident neurological symptoms (CNS-2; with \<5 WBC per μL and cytology positive for blasts) * Adequate organ function as defined by a creatinine clearance \> 50 ml/min, serum total bilirubin \< 5 times the normal value, left ventricular ejection fraction \> 40% * ECOG performance status ≤ 2 * Life expectancy \> 3 months * Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression * Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods * Male patients must use highly effective contraception methods Exclusion Criteria: * Patients with CNS-3 leukaemia. * Active cancer (other than B-ALL). * Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder. * Presence of active autoimmune disease or atopic allergy. * HIV serology positivity. * Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay. * Uncontrolled sepsis * Pregnant / nursing female. * Ongoing prednisolone \> 1mg/kg daily or equivalent. * Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.
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) · Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria. · Participants will be followed for the duration of the treatment, with an expected average of 3 months.；Complete response (CR) · Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression. · 12 Months；CR with incomplete blood recovery (CRi). · Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression. · 12 Months
次要终点：Overall survival (OS)；Progression free survival (PFS)；Time to next treatment (TTNT)；Percentage of adverse events
先给予氟达拉滨和环磷酰胺预处理化疗，随后单次静脉输注CAR转导的自体T细胞。
II/III期、前瞻性、单臂、开放标签研究，旨在评估静脉输注自体CD19 CAR-T细胞治疗复发/难治性B细胞急性淋巴细胞白血病的安全性和疗效。
This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia
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