肿瘤细胞治疗研究
英文原题：CD19/22 Bi-specific CAR-T Cell Therapy
这是一项 I/II 期注册临床试验，评估 CD19T 细胞治疗 B 细胞恶性肿瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 60 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT05432882。
不限性别 · ≥ 6 Months 且 ≤ 75 Years
纳入标准： 1. 年龄大于6个月。 2. 恶性B细胞表面表达CD19或CD22。 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，导致患者反应难以评估。 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CD19和CD22 CAR-T治疗失败。
Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD22 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 patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with HIV.4. active HBV or HCV infection. 5\. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD22 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 bi-4SCARCD19/22 T cells in patients with B cell malignancies · Safety of fourth generation bi-4SCARCD19/22 T cells in patients with B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events · 24 weeks
次要终点：Anti tumor activity of fourth generation bi-4SCARCD19/22 T cells in patients with relapsed or refractory B cell malignancies
本研究旨在评估抗CD19/CD22双特异性CAR-T细胞疗法用于CD19和/或CD22阳性B细胞恶性肿瘤患者的可行性、安全性和疗效，并进一步了解该疗法的安全性、功能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 anti-CD19/22 bi-specific CAR-T cell therapy in patients with CD19 and/or CD22 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/22 bi-specific CAR-T cells and their persistency in patients.
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