肿瘤细胞治疗研究
英文原题：GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-02)
这是一项早期 I 期注册临床试验，评估细胞治疗用于肉瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 1 例。试验地点：其他 · 卡尔加里（共 1 个中心）。登记号：NCT06789081。
不限性别 · ≥ 18 Years
纳入标准： • 完成知情同意书签署。 • 器官功能充分，定义为肌酐清除率>30 mL/min且左心室射血分数（LVEF）>45%。 排除标准： • 任何活动性未控制感染、妊娠或哺乳。
Inclusion Criteria: * Completion of Informed Consent Form * Adequate organ function, defined as creatinine clearance \>30 ml/min and LVEF \>45%. Exclusion Criteria: * Any active uncontrolled infection, pregnancy or nursing.
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：Assess for anti-tumor activity · Response is the primary endpoint of this study. Diagnostic imaging (CT and/or MRI) will be performed pre-infusion to document measurable disease, and 4-6 weeks after GCAR1 T-cell infusion to evaluate response to therapy. · 1 year
GCAR1是一种患者特异性细胞治疗产品，由自体淋巴细胞组成；这些细胞经含嵌合抗原受体（CAR）的慢病毒载体转导，可特异性靶向表达细胞表面蛋白非转移性糖蛋白B（GPNMB）的肿瘤细胞。
CLIC-YYC-GPNMB-02是一项按加拿大卫生部2019年发布的模板和指南设计的单患者研究（SPS），适用于患者已无其他治疗或治愈选择、但仍可获得其他途径无法提供的治疗的情形。拟纳入患者患有进展性转移性肺泡软组织肉瘤（ASPS）。研究拟使用GCAR1治疗，这是一种患者特异性细胞治疗产品，由自体淋巴细胞组成；这些细胞经含嵌合抗原受体（CAR）的慢病毒载体转导，可特异性靶向表达细胞表面蛋白非转移性糖蛋白B（GPNMB）的肿瘤细胞。
CLIC-YYC-GPNMB-02 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-02 has progressive metastatic alveolar soft part sarcoma (ASPS). We propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).
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