肿瘤细胞治疗研究
英文原题：CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
⚠ 该试验的登记信息已有 19 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。
这是一项分期未标注的注册临床试验，评估 CAR-T 细胞治疗淋巴瘤、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 18 例。试验地点：中国 · 香港（共 1 个中心，其中中国 1 个）。登记号：NCT06866873。
不限性别 · ≥ 1 Year 且 ≤ 17 Years
纳入标准： * 受试者必须患有复发或难治性ALL或淋巴瘤，且已接受至少两线治疗。疾病必须在末次方案治疗后进展，或末次方案治疗未能达到部分或完全缓解。 * 患者疾病必须为CD19阳性，通过末次可用活检的免疫组织化学或流式细胞术分析确认。 * 年龄1-17岁。 * 体能状态：> 10岁受试者：Karnofsky ≥ 50%；≤ 10岁受试者：Lansky量表 ≥ 50%。 * 器官功能正常。 * 总胆红素 ≤ 3倍正常上限 * AST（SGOT）≤ 5倍正常上限 * ALT（SGPT）≤ 5倍正常上限 * 血清肌酐 ≤ 2倍正常上限 * 受试者必须具有以下血液学功能参数：血红蛋白（Hb）水平 > 8 g/dL；绝对淋巴细胞计数 > 0.1x10^9/L；血小板 > 50x10^9/L * 既往治疗洗脱期。在受试者计划进行白细胞采集时，距任何既往全身治疗必须已至少经过2周或5个半衰期，以较短者为准。 * 受试者的父母或法定监护人必须能够理解并愿意签署书面知情同意文件。 排除标准： * 计划CAR T细胞输注前6周内接受过自体移植。 * 接受过本方案以外的CAR-T细胞治疗。 * 活动性中枢神经系统（CNS）或脑膜肿瘤侵犯。 * 除非黑色素瘤皮肤癌、原位癌（如宫颈、膀胱、乳腺）外，有其他活动性恶性肿瘤病史。 * 活动性人类免疫缺陷病毒（HIV）感染。 * 受试者患有未控制的并发疾病，包括但不限于持续或活动性感染、有症状的充血性心力衰竭、不稳定型心绞痛、心律失常、肺部异常或精神疾病/社会状况，会限制对研究要求的依从性。 * 妊娠或哺乳期女性。 * 治疗开始前任何骨髓活检显示骨髓增生异常或提示骨髓增生异常的细胞遗传学异常的证据。 * 血清学状态反映活动性乙型或丙型肝炎感染。
Inclusion Criteria: * Subjects must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen. * The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available. * Age 1-17 years. * Performance status: Subjects \> 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50%. * Normal organ function. * Total bilirubin ≤ 3 times upper limit of normal * AST (SGOT) ≤ 5 times upper limit of normal * ALT (SGPT) ≤ 5 times upper limit of normal * Serum Creatinine ≤ 2 times upper limit of normal * Subjects must have the following hematologic function parameters: Hemoglobin (Hb) level \> 8 g/dL; Absolute Lymphocyte Count \> 0.1x10\^9/L; Platelet \> 50x10\^9/L * Prior therapy wash-out. At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis. * Subjects' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Autologous transplant within 6 weeks of planned CAR T cell infusion. * Recipient of CAR-T cell therapy outside of this protocol. * Active central nervous system (CNS) or meningeal involvement by tumor. * History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast). * Active human immunodeficiency virus (HIV) infection. * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breastfeeding women. * Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy. * Serologic status reflecting active hepatitis B or C infection.
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 response rate (CRR) for ALL and Overall response rate (ORR) for lymphoma · Complete response for ALL was defined as leukemic cells \<5% in bone marrow. Overall response for lymphoma was defined as complete response plus partial response defined by Lugano criteria. · 1 month for subjects with ALL, and 3 months for subjects with lymphoma；Incidence and severity of adverse events · Severity of adverse events are graded according to CTCAEv5.0. · through study completion, an average of 6 months
次要终点：Frequency of minimal residual disease for ALL；Overall survival；Event-free survival；Proportion of products successfully manufactured
静脉输注CAR-T细胞一次
本研究旨在探讨在复发或难治性急性淋巴细胞白血病（ALL）或淋巴瘤儿童中，给予化疗淋巴清除方案后，输注经引入靶向B细胞表面抗原CD19的嵌合抗原受体（CAR）修饰的自体T细胞的疗效和安全性。本研究的总体目标是验证CD19-CAR T细胞输注的安全性特征，并描述复发/难治性ALL或淋巴瘤儿童的缓解率。
This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.
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