CARsgen Therapeutics Holdings Limited a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the completion of enrollment in the pivotal Phase II clinical trial of satricabtagene autoleucel (“satri-cel”, R&D code: CT041, an autologous CAR-T product candidate against Claudin18.2) in accordance with the clinical protocol, for advanced gastric/gastroesophageal junction cancers (GC/GEJ) in China.This study is an open-label, multicenter, randomized clinical trial in China evaluating the efficacy and safety of satri-cel in subjects with Claudin18.2-positive advanced GC/GEJ patients who have failed at least two prior lines of therapy.

CARsgen Therapeutics Holdings Limited是一家专注于治疗血液系统恶性肿瘤和实体瘤的创新CAR T细胞疗法的公司，宣布完成satricabtagene autoleucel（“satri-cel”，研发代码：CT041，一种针对Claudin18.2的自体CAR-T候选产品）的关键II期临床试验的注册，该试验符合临床方案，用于中国的晚期胃/胃食管交界癌（GC/GEJ）。这项研究是一项在中国进行的开放标签，多中心，随机临床试验，评估了satri-cel在Claudin18.2阳性晚期GC/GEJ患者中的疗效和安全性，这些患者至少有两个治疗方案失败。

Treatment for the control group is physician’s choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab).Gastric cancer is one of the most common malignant tumors in China, with an incidence of approximately 359,000 incident cases and a mortality of approximately 260,000 deaths in 2022[1]. Patients with advanced gastric cancer often face limited treatment options and poor prognosis.

对照组的治疗是医生的选择（紫杉醇，多西紫杉醇，伊立替康，阿帕替尼或nivolumab）。胃癌是中国最常见的恶性肿瘤之一，2022年发病率约为359000例，死亡率约为260000例（1）。晚期胃癌患者通常面临有限的治疗选择和不良预后。

There is a strong need for more innovative and efficacious therapies. Satri-cel is an autologous CAR T-cell product candidate against Claudin18.2 that has the potential to be first-in-class globally. It primarily targets GC/GEJ and pancreatic cancer (PC). The published clinical data on satri-cel have shown promising safety and efficacy.The final results of the investigator-initiated Phase I clinical trial CT041-CG4006 (NCT03874897) were published in Nature Medicine and orally presented at the 2024 ASCO annual meeting.

迫切需要更具创新性和有效的疗法。。它主要针对GC/GEJ和胰腺癌（PC）。satri-cel上公布的临床数据显示出良好的安全性和有效性。研究者发起的I期临床试验CT041-CG4006（NCT03874897）的最终结果发表在《自然医学》上，并在2024年ASCO年会上口头介绍。

There were no dose-limiting toxicities (DLTs), no Grade 3 or higher cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) observ.

没有剂量限制性毒性（DLT），没有3级或更高级别的细胞因子释放综合征（CRS）或免疫效应细胞相关神经毒性综合征（ICANS）观察。