肿瘤细胞治疗研究
英文原题：The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
⚠ 该试验的登记信息已有 24 个月未更新， 页面上显示的「邀请入组」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 期注册临床试验，评估细胞治疗用于胶质母细胞瘤的安全性、可行性及初步疗效。当前状态：邀请入组。计划入组 50 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT06616727。
不限性别 · ≥ 18 Years
纳入标准：年龄≥18岁，性别不限；有胶质母细胞瘤病史，且复发性胶质母细胞瘤经组织学/分子病理学确认（包括WHO 4级星形细胞瘤）；KPS≥50；预计生存期≥12周；有生育能力女性的血妊娠试验阴性；患者本人和/或法定监护人同意参加试验并签署知情同意书。排除标准：已知对研究药物或可能使用的药物过敏；心、肺、肝或其他重要器官严重合并疾病；高血压控制不佳，或伴高血压危象/高血压脑病；除胶质母细胞瘤外另有严重中枢神经系统疾病、并发症或侵袭性恶性肿瘤；长期使用免疫抑制药物或大剂量类固醇；淋巴细胞单采前4周内接种活疫苗或减毒活疫苗，或接受与胶质母细胞瘤无关的其他手术；淋巴细胞单采或细胞输注合并感染或不明原因发热。
Inclusion Criteria: * Age ≥18，both sexes; * Diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma World Health Organization (WHO) Grade 4); * Karnofsky (KPS) ≥50; * The estimated survival time is ≥12 weeks; * Blood pregnancy tests for women of childbearing age are negative; * The patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form. Exclusion Criteria: * Known allergies to study drugs or drugs that may be used in the study; * Severe concurrent diseases in the heart, lungs, liver, or other vital organs; * Hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy; * In addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies; * Long-term use of immunosuppressant drugs, or large doses of steroids; * Received live or attenuated vaccine or other surgery had no related to GBM within 4 weeks prior to Lymphocytes apheresis; * Lymphocytes apheresis or cell infusion combined with infection or unexplained fever.
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：Incidence of treatment related adverse events · Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results · Up to 28 days after first infusion；DLT · Incidence of DLT associated with CAR-T cell transfusion within 28 days of the first infusion · Up to 28 days after first infusion
次要终点：Overall survival (OS) after infusion；Time maximum of SNC-109 Cell count and CAR vector copy number；Pharmacokinetic (PK) profile/parameters Peak Plasma Concentration (Cmax) of SNC-109 Cell count and CAR vector copy number；Pharmacokinetic (PK) profile/parameters Area under the plasma concentration versus time curve (AUC)；Progression free survival (PFS) after infusion；Efficacy assesment for the treatment according to iRANO；Pharmacodynamic (PD) profile/parameters Changes of Cytokines after infusion；Concentration of Human anti-chimeric antibody (HACA)
完成筛查和评估后输注SNC-109 CAR-T细胞。
I期研究，评估SNC-109治疗复发性胶质母细胞瘤（rGBM）患者的安全性、耐受性和药代动力学。
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM
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