肿瘤细胞治疗研究
英文原题：Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies
这是一项早期 I 期注册临床试验，评估体内 CAR-T 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：招募中。计划入组 47 例。试验地点：中国 · 重庆（共 1 个中心，其中中国 1 个）。登记号：NCT07349849。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准：年龄18-70岁，性别不限；预期生存期超过12周；确诊CD19阳性B细胞淋巴瘤或淋巴细胞白血病，且指南未推荐标准治疗方案；淋巴瘤患者须有可评估病灶；ECOG体能状态0-1分；登记文本注明可能还有其他纳入条件。排除标准：合并其他未控制的恶性肿瘤；既往接受嵌合抗原受体治疗或其他转基因T细胞治疗；已知HIV、乙肝（HBsAg阳性且HBV DNA达到检测限）或丙肝病毒（抗HCV阳性）感染史；有中枢神经系统淋巴瘤史、脑脊液恶性细胞或脑转移；研究者认为不适合参加试验的其他因素；登记文本注明可能还有其他排除条件。
Inclusion Criteria: * 1\. Age range of 18-70 years old, gender not limited; * 2\. Expected survival time exceeds 12 weeks; * 3\. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines * 4\. There are assessable lesions (applicable only to lymphoma patients); * 5\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1; * May involve other inclusion criteria Exclusion Criteria: * 1\. Accompanied by other uncontrolled malignant tumors; * 2\. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy; * 3\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection; * 4\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases; * 5\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial. May involve other exclusion criteria
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：Dose limiting toxicity (DLT) and its incidence rate · Within 28 days after the initial treatment；Maximum tolerated dose (MTD) or optimal biological dose (OBD) · 3 months
次要终点：Objective response rate (ORR)；Disease control rate (DCR)；Progression free survival (PFS)
成人B细胞来源的血液恶性肿瘤主要包括急性淋巴细胞白血病（ALL）和非霍奇金淋巴瘤（NHL）。尽管现有治疗显著提高了多数患者的生存率，复发/难治患者仍面临重大治疗挑战。CD19是B细胞恶性血液肿瘤中临床价值较高的靶点。COVID-19疫苗的出现使LNP-mRNA技术受到广泛关注。经过多年发展，该技术不仅用于疫苗，也已在癌症、罕见病等领域开展治疗研究。脂质纳米颗粒（LNP）是目前较成熟的非病毒递送平台，可保护mRNA免受核酸酶降解、促进细胞摄取，并实现体内高效翻译。靶向CD19的LNP-mRNA技术核心是将编码特定蛋白（如抗CD19相关蛋白）的mRNA包裹在LNP中，经静脉或肌内注射递送至体内。
Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors. The advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. Lipid nanoparticles (LNP) are currently the most mature non viral delivery platform, capable of protecting mRNA from nuclease degradation, promoting intracellular uptake, and achieving efficient translation in vivo. The core of LNP-mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins (such as anti-CD19 related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
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