预约演示
更新于：2025-05-30
Satricabtagene autoleucel
舒瑞基奥仑赛
更新于：2025-05-30
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
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
NCT04404595
Open-label, Multicenter, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects with Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers
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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7
项与 舒瑞基奥仑赛 相关的文献（医药）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 ; Zhang, Xiaotian ; Ma, Mingyang
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
2024-08-01NATURE MEDICINE
Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results
Article
作者: Yuan, Daijing ; Zhang, Miao ; Ge, Sai ; Qi, Changsong ; Shen, Lin ; Liu, Chang ; Li, Jian ; Peng, Xiaohui ; Wang, Zhenghang ; Zhang, Panpan ; Lu, Zhihao ; Xue, Ran ; Yuan, Jiajia ; Qin, Yanru ; Zhou, Jun ; Liu, Dan ; Wang, Yumeng ; Wang, Yakun ; Gong, Jifang ; Lu, Ming ; Zhang, Xiaotian ; Peng, Zhi ; Wang, Xicheng ; Cao, Yanshuo
Claudin18.2 (CLDN18.2) is highly expressed with the development of various malignant tumors, especially gastrointestinal cancers, and is emerging as a new target for cancer treatment. Satricabtagene autoleucel (satri-cel)/CT041 is an autologous chimeric antigen receptor (CAR) T cell targeting CLDN18.2, and the interim results of the CT041-CG4006 trial were reported in June 2022. Here we present the final results of this single-arm, open-label, phase 1 trial, which evaluated the safety and efficacy of satri-cel in patients with CLDN18.2-positive advanced gastrointestinal cancers. This trial included a dose-escalation stage (n = 15) and a dose-expansion stage in four different cohorts (total n = 83): cohort 1, satri-cel monotherapy in 61 patients with standard chemotherapy-refractory gastrointestinal cancers; cohort 2, satri-cel plus anti-PD-1 therapy in 15 patients with standard chemotherapy-refractory gastrointestinal cancers; cohort 3, satri-cel as sequential treatment after first-line therapy in five patients with gastrointestinal cancers; and cohort 4, satri-cel monotherapy in two patients with anti-CLDN18.2 monoclonal antibody-refractory gastric cancer. The primary endpoint was safety; secondary endpoints included efficacy, pharmacokinetics and immunogenicity. A total of 98 patients received satri-cel infusion, among whom 89 were dosed with 2.5 × 108, six with 3.75 × 108 and three with 5.0 × 108 CAR T cells. Median follow-up was 32.4 months (95% confidence interval (CI): 27.3, 36.5) since apheresis. No dose-limiting toxicities, treatment-related deaths or immune effector cell-associated neurotoxicity syndrome were reported. Cytokine release syndrome occurred in 96.9% of patients, all classified as grade 1-2. Gastric mucosal injuries were identified in eight (8.2%) patients. The overall response rate and disease control rate in all 98 patients were 38.8% and 91.8%, respectively, and the median progression-free survival and overall survival were 4.4 months (95% CI: 3.7, 6.6) and 8.8 months (95% CI: 7.1, 10.2), respectively. Satri-cel demonstrates therapeutic potential with a manageable safety profile in patients with CLDN18.2-positive advanced gastrointestinal cancer. ClinicalTrials.gov identifier: NCT03874897 .
244
项与 舒瑞基奥仑赛 相关的新闻（医药）2025-05-29
·医药观澜
优先审批细胞疗法孤儿药突破性疗法免疫疗法
2025-05-28
·同写意
ASCO会议优先审批细胞疗法孤儿药免疫疗法
2025-05-28
·同写意
细胞疗法优先审批免疫疗法孤儿药ASH会议
100 项与 舒瑞基奥仑赛 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 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 | |
| 胰腺癌 | 临床2期 | 中国 | 2020-10-23 | |
| 胰腺癌 | 临床2期 | 加拿大 | 2020-10-23 | |
| 胃腺癌 | 临床2期 | 中国 | 2020-10-23 | |
| CLDN18.2阳性胰腺癌 | 临床1期 | 中国 | 2023-08-03 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 41 | tisa-cel CAR-T细胞治疗 | 蓋構窪獵膚願憲憲壓醖(糧糧鏇艱襯積齋襯鑰襯) = 鹽糧窪廠夢糧範顧網鑰 選膚繭淵遞觸網顧糧艱 (鑰襯繭夢積憲鹽獵夢鹹 ) 更多 | 积极 | 2025-01-23 | ||
临床2期 | - | 簾鬱鬱顧壓夢夢製鹹網(夢築憲築糧網鹽獵夢廠) = 具有统计学意义上的显著改善。 遞願廠鹹鏇廠襯鏇觸襯 (簾衊糧願淵製餘醖夢遞 ) 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) | 蓋齋築網獵蓋糧築憲衊(襯淵鏇壓獵簾憲網鬱衊) = None 憲糧鑰糧餘夢遞積簾壓 (築製繭餘範繭繭襯鹹醖 ) 更多 | 积极 | 2024-06-03 | |
(dose-expansion stage) | |||||||
N/A | 24 | 衊壓齋艱廠襯顧願壓構(糧觸夢構襯糧壓遞糧顧) = 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. 窪選構廠遞鬱築製製遞 (獵獵衊簾遞構選遞選網 ) 更多 | 积极 | 2024-05-24 | |||
临床1期 | 98 | 製醖願憲窪艱築醖衊醖(壓鬱壓膚選窪繭顧築簾) = grade 3 or higher were hematologic toxicity related to lymphodepletion 鏇餘選鑰鏇衊範鹽襯餘 (膚餘廠醖齋觸艱簾鹹蓋 ) 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) | 淵築積鬱鹹簾觸網壓餘(壓觸襯願選襯願願壓簾) = 鏇鏇選膚餘遞鬱鹹艱鹽 蓋範鑰齋築願範夢糧製 (範鹽鬱積鹹艱構製衊網 ) 更多 | 积极 | 2024-01-19 | ||
(DL3：600×106) | 繭範襯餘製範壓獵夢衊(襯製製顧觸膚淵衊壓衊) = 衊蓋糧鹹齋壓衊網窪廠 夢鬱衊憲壓糧網構醖齋 (蓋襯衊窪蓋憲範積顧積 ) 更多 | ||||||
临床1/2期 | 14 | 襯製糧憲鏇製鑰觸製網(糧鬱簾顧憲憲艱築選築) = Most CRS were grade 1 or 2, and only one patient experienced grade 4 CRS and fully recovered 鹽襯鬱夢選鏇壓遞廠繭 (鏇鬱憲製鹹鑰獵願膚衊 ) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 37 | 鏇壓鏇鹹製糧淵鑰醖顧(簾夢繭蓋簾顧窪衊鬱夢) = hematologic 100% 餘窪顧膚選鬱齋繭顧選 (憲鹽積廠簾蓋淵獵膚蓋 ) | 积极 | 2022-05-09 | |||
临床1期 | 消化系统肿瘤 三线 | 37 | 衊觸醖壓窪淵鹹廠膚繭(淵憲憲願範構窪廠壓鹹) = 觸積鏇顧廠糧鏇糧鑰鹽 襯鹽襯壓憲淵簾餘鹽網 (積簾鑰艱構齋遞膚製觸 ) 更多 | 积极 | 2021-09-19 | ||
(patients with gastric cancer) | 艱觸遞壓壓鏇醖顧齋遞(遞選廠鬱繭遞製憲襯蓋) = 餘糧鬱簾齋衊鏇憲壓繭 窪淵願糧齋構窪積憲願 (糧築觸鏇蓋積齋簾簾顧, 37.2 ~ 75.5) | ||||||
临床1期 | 12 | autologous CAR-CLDN18.2 T cells | 獵鏇壓淵憲齋觸觸夢窪(獵窪壓製膚製蓋積鏇衊) = none 膚繭範觸淵糧醖範壓衊 (艱鏇網蓋築襯觸壓壓壓 ) 更多 | 积极 | 2019-06-04 |
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