肿瘤细胞治疗研究
英文原题：Multi-4SCAR-T Therapy Targeting Breast Cancer
这是一项 I/II 期注册临床试验，评估 CAR-T 细胞治疗乳腺癌的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 100 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT04430595。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 经组织学和活检证实为III期、IV期或复发性乳腺癌。 2. 年龄≥18岁且≤75岁。 3. 末次化疗或放疗后至少间隔2周；末次全身性类固醇激素或其他免疫抑制治疗后至少间隔2周。 4. 化疗副作用已消退。 5. 通过免疫组化或流式细胞术证实恶性组织表达靶抗原GD2、CD44v6或Her2。 6. ECOG体能状态评分0或1。 7. 预期生存期≥12周。 8. 初步造血恢复：中性粒细胞绝对计数（ANC）≥1×10^6/L，血小板（PLT）≥1×10^8/L。 9. 肾、肝功能适当：血清肌酐≤正常值上限（ULN）的2倍，血清胆红素≤ULN的3倍，AST/ALT≤ULN的2.5倍。 10. 氧饱和度≥90%。 11. 在任何研究特定操作前已获得书面知情同意。 排除标准： 1. 肿瘤导致气道梗阻。 2. 有癫痫或其他中枢神经系统疾病史。 3. 需要全身性糖皮质激素或其他免疫抑制治疗。 4. 有QT间期延长或严重心脏病史。 5. 当前或近期（第0天前28天内）接受其他试验药物治疗，或既往参加过本研究。 6. 肝肾功能不足：血清肌酐>1.5 mg/dL、总胆红素>2.0 mg/dL或AST/ALT>ULN的3倍。 7. 妊娠或哺乳期女性。 8. 筛查期间存在严重活动性感染。 9. 活动性HIV、HBV或HCV感染，或未控制的感染。 10. 研究者认为患者可能不符合资格或无法遵守研究要求。
Inclusion Criteria: 1. Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy. 2. Age: ≥ 18 years and ≤ 75 years. 3. 2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy. 4. Side effects of chemotherapy have subsided. 5. The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry. 6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 7. Expected survival ≥ 12 weeks. 8. Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1×10\^6/L; platelet (PLT) ≥ 1×10\^8/L. 9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 3×ULN; AST/ALT ≤ 2.5×ULN. 10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures. Exclusion Criteria: 1. Airway obstruction caused by tumor. 2. History of epilepsy or other central nervous system diseases. 3. Patients who require systemic corticosteroid or other immunosuppressive therapy. 4. History of prolonged or serious heart disease during QT. 5. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 6. Inadequate liver and renal function with serum creatinine \> 1.5 mg/dl; serum (total) bilirubin \> 2.0 mg/dl; AST \& ALT \> 3 x ULN. 7. Pregnant or lactating females. 8. Serious active infection during screening. 9. Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection. 10. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
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 patients with adverse events. · Determine the toxicity profile the multi-4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0 · 3 year
次要终点：Anti-tumor effects；The expansion and persistence of CAR-T cells；Survival time of the patients
多靶点4SCAR T细胞治疗乳腺癌。
本研究旨在评估靶向Her2、GD2和CD44v6表面抗原的多种第四代CAR-T细胞治疗乳腺癌的可行性、安全性和疗效。研究还将进一步了解多靶点CAR-T细胞的活性及其在患者体内的持续情况。
The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients.
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