肿瘤细胞治疗研究
英文原题：A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma
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：招募中。计划入组 10 例。试验地点：韩国 · 城南（共 1 个中心）。登记号：NCT07143812。
不限性别 · ≥ 19 Years 且 ≤ 70 Years
纳入标准：年龄19-70岁；经胶质母细胞瘤标准治疗后，根据医学影像确诊新诊断胶质母细胞瘤；预期生存期至少3个月；既往未接受其他类型免疫治疗；研究者已充分说明临床试验目的、细节及研究药物特征，且受试者本人或法定监护人/代表在试验开始前签署知情同意书。排除标准：复发性胶质母细胞瘤；已知二氢嘧啶脱氢酶（DPD）缺乏；增强MRI禁忌（如装有起搏器或因其他原因无法按研究安排接受MRI）；手术中植入Gliadel晶片；研究者判定肝、肾、骨髓、肺或心脏等主要器官严重功能障碍；合并胶质母细胞瘤以外恶性肿瘤，或过去5年内恶性肿瘤史；未控制的低血压或高血压；研究者判定的严重感染，包括败血症、甲/乙/丙型肝炎；Karnofsky体能状态评分<50；累及中枢神经系统的自身免疫病（如多发性硬化、重症肌无力、急性播散性脑脊髓炎）；对氟胞嘧啶（5-FC）、其辅料或5-氟尿嘧啶（5-FU）过敏；妊娠、哺乳、计划在研究期间妊娠或不愿采取适当避孕措施；入组前30天内参加其他临床试验；研究者认为不适合参加研究的其他情况。
Inclusion Criteria: * Patients aged 19 to 70 * Patients diagnosed with newly diagnosed glioblastoma based on medical imaging after receiving standard therapy for glioblastoma * Patients whose expected survival period is at least 3 months * Patients who have not received any other types of immunotherapy * Patients who have been given a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of this clinical trial Exclusion Criteria: * Patients with recurrent glioblastoma. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency Contraindications to contrast-enhanced MRI (e.g., patients with pacemakers or other reasons preventing MRI scans according to the study schedule) * Patients who received Gliadel wafer implantation during surgery * Patients with severe dysfunction of major organs (liver, kidney, bone marrow, lung, heart) as determined by the investigator * Patients with concurrent malignancies other than glioblastoma or a history of malignancy within the past 5 years * Patients with uncontrolled hypotension or hypertension * Patients with serious infections as determined by the investigator, including sepsis, hepatitis A, B, or C * Patients with a Karnofsky Performance Scale (KPS) score \< 50 * Patients with autoimmune diseases involving the central nervous system (e.g., multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis) * Patients with a history of allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU) * Pregnant or breastfeeding women, patients planning to become pregnant during the study period, or those unwilling to use appropriate contraception * Participation in another clinical trial within 30 days prior to enrollment * Any condition that, in the opinion of the investigator, would make the patient unsuitable for study participation
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：Number Of Adverse Events related to the treatment · Evaluate the number of adverse event related to the treatment according to CTCAE V4.0 during the trial (including clinically significant changes in physical examination, radiographic images, safety lab tests, vital signs) · Up to 12 months after treatment administration (Day 0)
手术期间使用注射器向肿瘤或肿瘤切除部位给药，每剂含1×10^7或3×10^7个细胞。
这是一项I期临床试验，评估表达自杀基因的研究性异体骨髓间充质干细胞疗法MSC11FCD用于新诊断胶质母细胞瘤患者的安全性、耐受性和最大耐受剂量。研究产品在手术切除后瘤内给药。本研究旨在探索MSC11FCD能否在术后阶段提供局部靶向治疗，以处理残余肿瘤细胞并降低早期复发风险。
This is a phase I clinical trial evaluating the safety, tolerability, and maximum tolerated dose of MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy expressing a suicide gene, in patients with newly diagnosed glioblastoma. The investigational product is administered intratumorally following surgical resection. This study aims to explore whether MSC11FCD can provide a targeted, localized treatment option during the postsurgical period, potentially addressing residual tumor cells and reducing early recurrence.
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