肿瘤细胞治疗研究
英文原题：Multi-CAR-T Cells Targeting B Cell Lymphomas
这是一项 I/II 期注册临床试验，评估 GD2 细胞治疗用于 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 11 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT04429438。
不限性别 · ≥ 6 Months 且 ≤ 75 Years
纳入标准： 1. 年龄大于6个月。 2. 原发B细胞淋巴瘤表面表达CD19和/或CD22、CD70、PSMA、CD13、CD79b或GD2。 3. Karnofsky体能状态评分>80分，预期生存期超过1个月。 4. 血红蛋白>80 g/L。 5. 无采集血细胞的禁忌证。 排除标准： 1. 合并其他活动性疾病，导致治疗后反应难以评估。 2. 存在无法控制的细菌、真菌或病毒感染。 3. HIV感染。 4. 活动性HBV或HCV感染。 5. 妊娠或哺乳期。 6. 治疗前一周内接受全身性类固醇治疗。 7. 既往CAR-T治疗失败。
Inclusion Criteria: 1. Age older than 6 months. 2. Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules. 3. The KPS score over 80 points, and survival time is more than 1 month. 4. Greater than Hgb 80 g/L. 5. No contraindications to blood cell collection. Exclusion Criteria: 1. Accompanied with other active diseases, and difficult to assess response after treatment. 2. Bacterial, fungal, or viral infection, unable to control. 3. Living with HIV. 4. Active HBV and HCV infection. 5. Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment. 7\. Prior failed CAR-T treatment.
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 fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion · Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells in patients with relapsed B cell lymphoma (BCL) using CTCAE 4 standard to evaluate the level of adverse events · 24 weeks
次要终点：Anti tumor activity of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion
化疗后复发或难治性B细胞淋巴瘤（BCL）患者将接受联合4SCAR基因工程T细胞治疗。
本研究旨在评估第四代嵌合抗原受体基因修饰T细胞联合方案的安全性和疗效，该方案靶向B细胞表面分子（包括CD19），并将其他CAR-T作为强化和巩固治疗，用于高度耐药的B细胞淋巴瘤患者，包括原发纵隔B细胞淋巴瘤（PMBCL）及累及中枢神经系统的B细胞淋巴瘤（CNS-BCL）。研究还将考察临床应答，并开发简化、标准化的慢病毒载体及细胞制备流程。本研究为多中心I/II期试验。
This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
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