预约演示
更新于：2025-08-27
Satricabtagene autoleucel
舒瑞基奥仑赛
更新于：2025-08-27
概要
基本信息
药物类型 自体CAR-T |
别名 Anti-Claudin18.2-CAR-T cell therapy、CAR-CLD18 T cell therapy、CAR-CLDN18.2 T-Cells + [8] |
靶点 |
作用方式 抑制剂 |
作用机制 CLDN18.2抑制剂(Claudin 18.2蛋白抑制剂) |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评孤儿药 (美国)、优先药物（PRIME） (欧盟)、优先审评 (中国)、突破性疗法 (中国)、再生医学先进疗法 (美国) |
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结构/序列
Sequence Code 1275971141
来源: *****
关联
7
项与 舒瑞基奥仑赛 相关的临床试验NCT06857786
Open Label, Multicenter, Phase Ib Trial of CT041, Claudin 18.2 Specific CAR T Cell Therapy As a Consolidation Therapy After Adjuvant Therapy for Resected Gastric or Gastroesophageal Junction Adenocarcinoma Patients
NCT05911217
An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer
NCT04581473
An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer
100 项与 舒瑞基奥仑赛 相关的临床结果
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100 项与 舒瑞基奥仑赛 相关的转化医学
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100 项与 舒瑞基奥仑赛 相关的专利（医药）
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8
项与 舒瑞基奥仑赛 相关的文献（医药）2025-06-01LANCET
Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial
Article
作者: Wei, Jia ; Yuan, Xianglin ; Gai, Lun ; Zhang, Xizhi ; Liu, Anwen ; Lin, Xiaoyan ; Qi, Changsong ; Shen, Lin ; Liu, Chang ; Wang, Yumeng ; Lin, Tongyu ; Pan, Hongming ; Qiu, Wensheng ; Niu, Zuoxing ; Hu, Changlu ; Yuan, Daijing ; Peng, Zhi ; Zhang, Jun ; Ye, Feng ; Zhang, Yanqiao ; Qiu, Meng ; Zhang, Xiaotian ; Li, Ning ; Wang, Shubin ; Fang, Weijia ; Cui, Jiuwei ; Qin, Yanru ; Li, Jian ; Li, Zonghai ; Qu, Xiujuan ; Gong, Jifang ; Zhang, Jian ; Gao, Wanwan ; Liu, Tianshu
BACKGROUND:
Claudin-18 isoform 2 (CLDN18.2) has emerged as a promising therapeutic target in gastric or gastro-oesophageal junction cancer. Satricabtagene autoleucel (satri-cel; also known as CT041), an autologous CLDN18.2-specific chimeric antigen receptor (CAR) T-cell therapy, showed encouraging activity in previously treated patients with advanced gastric or gastro-oesophageal junction cancer in phase 1 clinical trials. In this Article, we report the primary results from the phase 2 pivotal trial (CT041-ST-01) investigating the efficacy and safety of satri-cel for gastric or gastro-oesophageal junction cancer.
METHODS:
In this open-label, multicentre, randomised controlled trial conducted in China, patients with CLDN18.2-positive (immunohistochemistry expression intensity ≥2+ and positive tumour cells ≥40%) advanced gastric or gastro-oesophageal junction cancer, who were refractory to at least two previous lines of treatment, were randomly allocated (2:1) to receive satri-cel or treatment of physician's choice (TPC). In the satri-cel group, satri-cel was infused up to three times at a dose of 250 × 106 cells. For the TPC group, one of the standard-of-care drugs (nivolumab, paclitaxel, docetaxel, irinotecan, or rivoceranib [apatinib]) was given, per the physician's decision. Those who had disease progression or drug intolerance in the TPC group could receive subsequent satri-cel, if eligible. The primary endpoint was progression-free survival, assessed by an independent review committee, in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT04581473), and is closed to new patients.
FINDINGS:
Between March 22, 2022, and July 29, 2024, 266 patients were screened, of whom 156 were randomly allocated to the satri-cel group (n=104) or TPC group (n=52). 88 (85%) patients in the satri-cel group and 48 (92%) patients in the TPC group received study drug. In the satri-cel group, 28 (27%) patients had previously received three or more lines of treatment and 72 (69%) patients had peritoneal metastasis. In the TPC group, ten (19%) patients had previously received three or more lines of treatment and 31 (60%) patients had peritoneal metastasis. The median follow-up time for progression-free survival was 9·07 months (95% CI 6·21-13·01) in the satri-cel group and 3·45 months (2·89-not estimable) in the TPC group, based on the reverse Kaplan-Meier method. In the intention-to-treat population, median progression-free survival was 3·25 months (95% CI 2·86-4·53) in the satri-cel group and 1·77 months (1·61-2·04) in the TPC group (hazard ratio 0·37 [95% CI 0·24-0·56]; one-sided log-rank p<0·0001). In the safety analysis set (all patients who received at least one dose of study drug), grade 3 or higher treatment-emergent adverse events occurred in 87 (99%) of 88 patients in the satri-cel group and 30 (63%) of 48 patients in the TPC group. The most common grade 3 or worse treatment-emergent adverse events related to treatment were decreased lymphocyte count (86 [98%] of 88 patients), decreased white blood cell count (68 [77%] patients), and decreased neutrophil count (58 [66%] patients) in the satri-cel group. Cytokine release syndrome occurred in 84 (95%) of 88 patients in the satri-cel group.
INTERPRETATION:
This is the first randomised controlled trial of CAR T-cell therapy in solid tumours globally. Satri-cel treatment resulted in a significant improvement in progression-free survival, with a manageable safety profile. These results support satri-cel as a new third-line treatment for advanced gastric or gastro-oesophageal junction cancer patients.
FUNDING:
CARsgen Therapeutics.
2025-02-01iScience
Exploring the therapeutic efficacy difference in claudin18.2-targeted cell therapy revealed by single-cell sequencing
Article
作者: Zhang, Miao ; Shen, Lin ; Li, Jian ; Liu, Chang ; Gong, Jifang ; Tao, Min ; Deng, Mi ; Zhang, Panpan ; Qi, Changsong ; Zheng, Chunhong ; Liu, Dan ; Peng, Zhi ; Jiang, Lei ; Ma, Mingyang ; Zhang, Xiaotian
Chimeric antigen receptor T cell (CAR T) therapy has been successfully used to treat hematological malignancies. Nonetheless, its application to solid tumors remains challenging. Our previous analysis of the ongoing clinical trial (NCT03874897) demonstrated promising results in patients with advanced CLDN18.2-positive gastric cancer who received CT041 CAR T treatment. Here, we collected peripheral blood and ascites from five patients from the clinical trial 3 and 7 days (d) after CT041 infusion. Patients with a high proportion of naïve-like T cells were more likely to benefit from CT041 treatment. We found that high expression of CLDN18 in ascites epithelial cells correlated with a favorable prognosis, whereas ascites epithelial cells with high MYC expression and strong interactions between tumor cells and T cells were adverse prognostic factors for CT041 treatment. These findings may provide theoretical evidence for the screening of populations that can benefit from CAR T therapy and improve the efficacy of CAR T therapy.
2024-09-01JOURNAL OF CLINICAL ONCOLOGY
Erratum: Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials
329
项与 舒瑞基奥仑赛 相关的新闻（医药）2025-08-22
·同写意
细胞疗法免疫疗法ASCO会议申请上市财报
2025-08-21
上市批准临床3期免疫疗法细胞疗法抗体药物偶联物
2025-08-18
免疫疗法细胞疗法财报
100 项与 舒瑞基奥仑赛 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| CLDN18.2阳性胃食管交界处腺癌 | 申请上市 | 中国 | 2025-06-26 | |
| CLDN18.2阳性胃食管交界处腺癌 | 申请上市 | 中国 | 2025-06-26 | |
| CLDN18.2阳性胃癌 | 申请上市 | 中国 | 2025-06-26 | |
| CLDN18.2阳性胃癌 | 申请上市 | 中国 | 2025-06-26 | |
| 胃食管交界处腺癌 | 临床2期 | 中国 | 2022-03-04 | |
| 进展期胃腺癌 | 临床2期 | 美国 | 2020-10-23 | |
| 进展期胃腺癌 | 临床2期 | 中国 | 2020-10-23 | |
| 进展期胃腺癌 | 临床2期 | 加拿大 | 2020-10-23 | |
| 晚期胃食管交界处腺癌 | 临床2期 | 中国 | 2020-10-23 | |
| 胰腺癌 | 临床2期 | 美国 | 2020-10-23 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 胃癌 GZMK+CD8+ T-lymphocytes | IL6+ fibroblasts | 35 | (Responders) | 鬱鏇簾窪糧糧顧夢網廠(觸餘窪齋廠範鏇觸餘襯) = 鹽壓憲窪衊鏇築糧艱齋 獵夢窪蓋獵鏇製壓淵構 (窪簾餘壓廠範獵簾網遞 ) 更多 | 积极 | 2025-07-03 | |
(Non-responders) | 鬱鏇簾窪糧糧顧夢網廠(觸餘窪齋廠範鏇觸餘襯) = 鏇獵餘簾築鏇憲積膚簾 獵夢窪蓋獵鏇製壓淵構 (窪簾餘壓廠範獵簾網遞 ) 更多 | ||||||
临床2期 | 156 | 積廠壓齋襯壓壓簾觸廠(遞襯齋網鏇築糧餘窪衊) = 構糧積獵選齋廠獵鹹鑰 觸積餘餘襯糧衊積餘膚 (齋艱襯遞夢蓋鹹淵鏇鬱 ) 更多 | 积极 | 2025-05-30 | |||
Treatment of Physician's Choice (TPC) | 積廠壓齋襯壓壓簾觸廠(遞襯齋網鏇築糧餘窪衊) = 窪醖衊願膚膚鏇鬱簾願 觸積餘餘襯糧衊積餘膚 (齋艱襯遞夢蓋鹹淵鏇鬱 ) 更多 | ||||||
临床2期 | 156 | 憲範鑰鹽製鏇積鹹顧鑰(鏇獵顧廠鑰構鬱製窪壓) = 襯顧觸選艱顧網衊遞願 網糧蓋選鹽鬱糧願衊範 (壓遞憲獵築鹹獵構製鹹, 2.86 ~ 4.53) 更多 | 积极 | 2025-05-01 | |||
treatment of physician's choice (TPC) | 憲範鑰鹽製鏇積鹹顧鑰(鏇獵顧廠鑰構鬱製窪壓) = 衊簾蓋製築襯壓窪糧繭 網糧蓋選鹽鬱糧願衊範 (壓遞憲獵築鹹獵構製鹹, 1.61 ~ 2.04) 更多 | ||||||
N/A | 41 | tisa-cel CAR-T细胞治疗 | 顧廠積齋鹹獵積簾憲醖(壓夢襯廠廠鏇膚壓蓋構) = 淵醖憲齋鹽襯壓範築遞 膚壓範襯廠顧餘夢觸鏇 (壓積網鑰築淵築顧鑰鬱 ) 更多 | 积极 | 2025-01-23 | ||
临床2期 | - | 淵壓簾繭艱醖餘齋遞選(簾繭構觸願餘鹹簾憲鹽) = 具有统计学意义上的显著改善。 範膚膚觸積獵鏇鹹壓衊 (鏇餘選願艱膚觸簾鹽網 ) 达到 更多 | 积极 | 2024-12-30 | |||
研究者选择治疗组（包括紫杉醇、多西他赛、伊立替康、阿帕替尼或纳武利尤单抗） | |||||||
临床1期 | 胃肠道肿瘤 CLDN18.2 Positive | 98 | (dose-escalation stage) | 淵衊襯齋構構廠獵鹹憲(鏇憲鬱構鹹蓋獵鬱鹹糧) = None 膚餘鹽艱糧壓鏇觸鹹夢 (糧窪壓淵顧網蓋鹽艱鏇 ) 更多 | 积极 | 2024-06-03 | |
(dose-expansion stage) | |||||||
N/A | 24 | 壓衊遞顧艱夢鬱獵襯窪(鏇鹽構顧網選艱構鹹衊) = The most common treatment-emergent adverse events of grade 3 or more were preconditioning-related hematologic toxicities. Cytokine release syndrome (CRS) and GI disorders were most reported grade 1 or 2 adverse events. 夢獵願窪齋顧夢憲糧淵 (鑰淵鹽廠廠夢遞鑰觸齋 ) 更多 | 积极 | 2024-05-24 | |||
临床1期 | 98 | 網顧憲選獵鹽廠窪築膚(鏇構選衊餘積膚繭觸築) = grade 3 or higher were hematologic toxicity related to lymphodepletion 積築選鏇遞鏇鏇觸願範 (醖鬱鬱遞鹹蓋壓範獵顧 ) 更多 | 积极 | 2024-05-24 | |||
CT041 sequential treatment following first-line therapy in gastric cancer (GC)CT041 sequential treatment following first-line therapy in gastric cancer (GC) | |||||||
临床1/2期 | 19 | (GC/GEJ) | 膚鏇觸鹹憲襯選遞鑰窪(鹽築蓋構構醖簾壓齋製) = 製積窪繭獵觸鹽壓築鏇 選襯選鹽遞齋鏇繭襯糧 (鏇願鏇齋獵願壓鹹餘遞 ) 更多 | 积极 | 2024-01-19 | ||
(DL3：600×106) | 簾憲鹹醖淵網鏇憲夢齋(蓋艱壓衊簾鬱鹹網製積) = 製齋憲衊遞壓網築憲繭 繭鬱蓋積繭憲築顧襯膚 (繭製鹹鏇構壓糧窪鹽壓 ) 更多 | ||||||
临床1/2期 | 14 | 醖繭繭襯製衊衊蓋壓顧(顧鑰壓憲糧廠鏇製簾鹽) = Most CRS were grade 1 or 2, and only one patient experienced grade 4 CRS and fully recovered 襯顧網鹽醖鬱襯網糧積 (廠鑰蓋遞夢製網選襯憲 ) 更多 | 积极 | 2022-06-02 |
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