肿瘤细胞治疗研究
英文原题：A Study of TIL in Advanced Solid Tumors (CZ)
这是一项 I 期注册临床试验，评估TIL（肿瘤浸润淋巴细胞）治疗实体瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 30 例。试验地点：中国 · 成都（共 1 个中心，其中中国 1 个）。登记号：NCT07294872。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： • 已切除肿瘤用于制备TIL，且产品成功制备。 • 年龄18至75岁。 • 组织学诊断为实体瘤。 • 预期生存期超过3个月。 • ECOG评分0至1。 • 标准治疗方案失败，并愿意接受TIL治疗。 • 至少有1个可评估肿瘤病灶。 排除标准： • 患有其他恶性肿瘤；已治愈、入组前已无活动≥5年且复发风险很低的恶性肿瘤除外；经充分治疗且无复发证据的非黑色素瘤皮肤癌或恶性雀斑样痣除外；经充分治疗且无复发证据的原位癌除外。 • 需要糖皮质激素治疗且泼尼松日剂量>10 mg（或其他激素等效剂量），或患有需要免疫调节治疗的自身免疫性疾病。 • 安静状态下呼吸室内空气时，指脉氧饱和度<95%。 • HIV感染或抗HIV抗体阳性；活动性HBV或HCV感染（HBsAg阳性和/或抗HCV阳性）；梅毒感染或梅毒螺旋体抗体阳性。 • 存在显著心血管异常。
Inclusion Criteria: * have one the tumor resection for TILs production and successfully produced； * Age: 18 years to 75years; * Histologically diagnosed as solid tumors; * Expected life-span more than 3 months; * ECOG score 0-1; * Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy; * At least 1 evaluable tumor lesion; Exclusion Criteria: * with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence; * Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment; * Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%; * Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive; * Significant cardiovascular anomalies
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：Adverse Events · To characterize the safety profile of GC101 TIL in patients with pancreatic ductal adenocarcinoma who were failed to standard treatment as assessed by incidence of adverse events. · 6 month
次要终点：Objective Response Rate (ORR)；Disease Control Rate (DCR）；Duration of Response (DOR)；Progression-Free Survival (PFS)；Overall Survival(OS)
采用羟氯喹（600 mg，单次给药）和环磷酰胺进行非清髓性淋巴细胞清除治疗后，将GC101 TIL经静脉输注给晚期实体瘤患者。
采用羟氯喹（600 mg，单次给药）和环磷酰胺进行非清髓性淋巴细胞清除治疗后，将GC203 TIL经静脉输注给晚期实体瘤患者。
本研究考察肿瘤浸润淋巴细胞（TIL）治疗晚期实体瘤患者的安全性和疗效。自体TIL和基因编辑TIL从切除的肿瘤组织中扩增，并在羟氯喹（600 mg，单次给药）和环磷酰胺进行非清髓性淋巴细胞清除治疗后，经静脉输注给患者。
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
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