肿瘤细胞治疗研究
英文原题：Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
⚠ 该试验的登记信息已有 24 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 I/II 期注册临床试验，评估抗 CD19 细胞治疗用于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 5 例。试验地点：其他 · 德黑兰（共 1 个中心）。登记号：NCT06635330。
不限性别 · ≥ 2 Years 且 ≤ 18 Years
纳入标准：年龄2-18岁，复发/难治性CD19阳性B-ALL；骨髓存在疾病；能够耐受白细胞单采；预期寿命>12周；Lansky或Karnofsky评分>50%；距末次化疗及末次皮质类固醇治疗至少7天；提供知情同意；有潜在造血干细胞移植供者。排除标准：存在研究疾病以外的活动性恶性肿瘤；MRI显示绿色瘤或白血病浸润，或有明显神经系统症状；任何CNS疾病；活动性GVHD；过去14天内接受放疗；既往接受抗CD19或抗CD20治疗；过去30天内接受供者淋巴细胞输注或其他细胞治疗；严重活动性感染；器官功能障碍。
Inclusion Criteria: * Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL * Presence of disease in the bone marrow * Able to tolerate the apheresis process * Life expectancy \> 12 weeks * Lansky or Karnofsky score \> 50% * At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids * Informed consent * Having potential donor for stem cell transplantation Exclusion Criteria: * Presence of active malignancy other than the disease under study * Chloroma and leukemic infiltration on MRI or significant neurological symptoms * Any CNS disorder * Presence of active GVHD * Radiation therapy within last 14 days * History of Anti-CD19 or Anti-CD20 therapy * Donor lymphocyte injection or other cell therapy methods within the last 30 days * Presence of severe active infection * Organ dysfunction
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：Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi) · First month and 2-3 months after intervention；Overall survival · First month and 3 months after intervention；Incidence of cytokine release syndrome: grade 3 and 4 · First month and 3 months after intervention；Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4 · First month and 3 months after intervention；Event-free survival · First month and 2-3 months after intervention
次要终点：Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)；Investigation of Minimal residual disease in patient；Incidence of cytokine release syndrome: grade 3 and 4；Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4；Incidence of tumor lysis syndrome (TLS)；Incidence of leukopenia；Incidence of infection；Event-free survival
本临床试验旨在评估CD19 CAR-T细胞治疗2-18岁复发或难治性B细胞急性淋巴细胞白血病（r/r B-ALL）儿童患者的安全性和疗效。研究主要关注：达到完全缓解（CR）或血象恢复不完全的完全缓解（CRi）的总缓解率；干预后首月及2-3个月的无事件生存率；以及干预后首月和3个月的总生存率。
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following: 1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)? 2. What is the rate of Event-free survival at first month and 2-3 months after intervention? 3. What is the rate of Overall survival at first month and at 3 months after the intervention?
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