肿瘤细胞治疗研究
英文原题：Combination Immunotherapy Targeting Sarcomas
这是一项 I/II 期注册临床试验，评估 CAR-T 细胞治疗肉瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 20 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT04433221。
不限性别 · ≥ 1 Year 且 ≤ 75 Years
纳入标准： 1. III期、IV期或复发性肉瘤患者。 2. 入组时年龄≥6个月且≤80岁。 3. 入组前末次标准化疗或放疗以及类固醇激素等免疫抑制治疗后至少间隔2周。 4. 化疗副作用已得到良好控制。 5. 通过免疫组化或流式细胞术确认恶性细胞表达CAR-T靶抗原。 6. Karnofsky/Lansky评分≥50%。 7. 预期生存期>8周。 8. ANC≥1×10^6/L，血小板≥1×10^8/L。 9. 室内空气下脉搏血氧饱和度≥90%。 10. 肝功能足够：AST<正常值上限（ULN）的5倍，总胆红素<ULN的3倍。 11. 肾功能足够：血清肌酐<ULN的2倍；若肌酐>ULN的1.5倍，须进行肌酐清除率检查。 12. 患者须有足量自体CAR-T细胞，剂量>0.5×10^6个细胞/kg体重。 13. 签署知情同意书及同意文件。 排除标准： 1. 疾病快速进展。 2. 正在接受其他新药治疗或参加相关评估。 3. 有证据提示肿瘤可能造成气道梗阻。 4. 有癫痫史或其他中枢神经系统疾病。 5. 需要使用免疫抑制药物。 6. 有长QT综合征或严重心脏病史。 7. 未控制的活动性感染。 8. 活动性乙型肝炎病毒、丙型肝炎病毒或HIV感染。 9. 入组前2周内接受全身性糖皮质激素治疗（吸入性类固醇除外）。 10. 既往接受过任何基因治疗。 11. 肌酐>2.5 mg/dL、ALT/AST>正常值上限3倍或胆红素>2.0 mg/dL。 12. 存在其他未控制疾病（如肺功能受阻），可能妨碍参加研究。 13. 妊娠或哺乳期女性。 14. 既往环磷酰胺或多柔比星毒性反应。 15. 肉瘤累及中枢神经系统。 16. 可能给受试者带来风险或干扰临床试验的其他情况。
Inclusion Criteria: 1. Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients; 2. Age: ≥ 6 months and ≤80 years of age at the time of enrollment; 3. At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment; 4. Side effects of chemotherapy have been well managed; 5. Confirmed malignant cell expression of CART target antigens by IHC or flow 6. Karnofsky /jansky score of 50% or greater; 7. Expected survival \> 8 weeks; 8. ANC≥ 1×10\^6/L，PLT ≥ 1×10\^8/L; 9. Pulse oximetry of≥90% on room air； 10. Adequate hepatic function, defined as aspartate aminotransferase(AST)\< 5 times upper limit of normal(ULN),serum bilirubin \< 3 times ULN; 11. Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed; 12. Patients must have sufficient autologous CART cells at does greater than 0.5x10\^6 cells/kg body weight; 13. Sign an informed consent and assent. Exclusion Criteria: 1. The disease is progressing rapidly; 2. The patient is receiving therapy of other new drugs and under evaluation; 3. Evidence of tumor potentially causing airway obstruction; 4. Epilepsy history or other CNS diseases; 5. Patients who need immunosuppressive drugs; 6. History of long QT syndrome or severe heart diseases; 7. Uncontrolled active infection; 8. Active hepatitis B virus, hepatitis C virus or HIV infection; 9. Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids; 10. Previous treatment with any gene therapy; 11. Creatinine\>2.5mg/dl or ALT/AST\>3 times normal or bilirubin\>2.0 mg/dl; 12. Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined; 13. Pregnant or lactating women; 14. Patients previously experienced toxicity from cyclophosphamide and doxorubicin; 15. Patients who have CNS sarcoma; 16. In condition that may bring risks to subjects or interference to clinical trials.
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：Safety of CART cells infusion · Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events · 3 months
次要终点：Overall survival Rate；Treatment response rate of sarcomas
适用于确认表达GD2、PSMA、Her2、CD276或其他标志物的肿瘤细胞患者。
本临床试验旨在评估低剂量化疗联合免疫治疗用于复发或晚期肉瘤患者的可行性、安全性和疗效。研究还将评估多种CAR-T细胞治疗后序贯肉瘤疫苗这一方案的安全性和疗效。
The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.
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