肿瘤细胞治疗研究
英文原题：Efficacy and Safety of CD7 CAR-T in Newly Diagnosed High-Risk T-LBL/ALL
这是一项早期 I 期注册临床试验，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：尚未开始招募。计划入组 10 例。登记号：NCT07476027。
不限性别 · ≤ 18 Years
纳入标准：年龄≤18岁；新诊断T-LBL/ALL；完成诱导化疗并达到CR1，骨髓MRD<0.01%；高危/极高危或诱导治疗反应不佳；复发风险高，经多学科团队（MDT）评估建议前瞻性采集并制备淋巴细胞；外周血淋巴细胞绝对计数（ALC）≥0.5×10^9/L，且一般情况良好（ECOG 0-1分或Lansky/Karnofsky评分≥80）。法定监护人同意签署书面知情同意书。输注标准：主要器官功能正常；左心室射血分数≥45%；血清肌酐≤同年龄正常值上限1.5倍；血清总胆红素、ALT/AST≤正常值上限3倍（明确与白血病浸润相关者除外）；无活动性未控制的严重感染。排除标准：研究者认为不适合入组的严重心肺功能不全；合并其他进展性恶性肿瘤；未得到有效控制的活动性和/或未控制感染；合并严重自身免疫病或先天性免疫缺陷；活动性肝炎（HBsAg和/或HBcAb阳性且研究中心HBV DNA高于正常上限，或抗HCV阳性且HCV RNA高于正常上限）；HIV感染或已知AIDS、梅毒感染；对生物制品（包括抗生素）有严重过敏史；异体造血干细胞移植后停用免疫抑制剂1个月仍存在急性GVHD；其他可能增加参与风险、干扰研究结局或被研究者判定不适合参加的严重身心疾病或实验室异常。
Inclusion Criteria: * Patients aged ≤18 years with newly diagnosed T-LBL/ALL. * Have completed induction chemotherapy and achieved CR1, with bone marrow MRD \< 0.01%. * High/very high-risk or poor induction response patients. * High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation. * Peripheral blood absolute lymphocyte count (ALC) ≥ 0.5×10⁹/L, and good general condition (ECOG score 0-1 or Lansky/Karnofsky score ≥ 80). * Legal guardian agrees to provide written informed consent. Infusion Criteria: * Essential normal function of major organs. * Left ventricular ejection fraction (LVEF) ≥ 45%. * Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for age. * Serum total bilirubin, ALT/AST ≤ 3 × ULN (unless clearly related to leukemic infiltration). * No active, uncontrolled severe infection. Exclusion Criteria: * Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment. * Complicated with other progressive malignant tumors. * Presence of active and/or uncontrolled infections that have not been effectively managed. * Complicated with severe autoimmune diseases or congenital immunodeficiency. * Active hepatitis \[positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than the upper limit of normal at the study center\]. * Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), syphilis infection.). * A history of severe hypersensitivity to biological products (including antibiotics). * Patients who have undergone allogeneic hematopoietic stem cell transplantation and still suffer from acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents. * Patients with other severe physical or mental diseases or abnormal laboratory test results that may increase the risk of study participation or interfere with study outcomes, as well as those who are deemed unsuitable for participation in this study by the investigator.
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：CR Rate · CR+CRi · 28 days after CD7 CAR-T cell infusion
本研究是一项开放、单中心、前瞻性临床试验，研究对象为新诊断高危T细胞淋巴母细胞淋巴瘤/急性淋巴细胞白血病（T-LBL/ALL）患者，计划入组10例。所有患者将在CR1缓解期采集淋巴细胞，随后制备并回输CD7 CAR-T细胞。研究将随访观察不良反应并收集治疗疗效相关数据，以评估CAR-T细胞治疗的安全性、疗效和细胞代谢动力学特征。
This study is an open, single-center, prospective clinical trial, with newly diagnosed high-risk T-LBL/ALL patients as the subjects. It plans to enroll 10 subjects. All patients will undergo lymphocyte collection during the CR1 remission period, followed by the preparation and reinfusion of CD7 CAR-T cells. Adverse reactions will be followed up and observed, and relevant data on treatment efficacy will be collected to evaluate the safety, efficacy, and cell metabolic kinetics characteristics of CAR-T cell therapy for the patients.
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