This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of EBV-TCR-T cells in patients with EB virus infection after HSCT.

开始日期2020-02-10

申办/合作机构

河北燕达陆道培医院

[+1]

NCT03648697 / Unknown status临床2期IIT

A Pilot Study of EBV-TCR-T(YT-E001) in NPC Patients

TCR-T cell therapy experienced a breakthrough for treating tumors in recent years. Phase I / II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma conducted by the Rosenberg team at the National Cancer Institute showed that 61% Synovial cell sarcoma and 55% melanoma had therapeutic responses. These and lots of clinical achievements indicate that TCR-T cell therapy can target a variety of tumors including solid tumors without any severe side effects found in CAR-T trials.
Nasopharyngeal carcinoma (NPC), a kinds of head-neck malignant tumor, which used to appear mostly in southern China (especially in Fujian and Guangdong and Guangxi provinces). Most patients with NPC show evidence of infection with the Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage NPC, and play a role in causing and inducing the disease program and development. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if EBV antigen special T cells (YT-E001) could recognize and kill special parts of EBV infected cells, and finally inhibit the tumor recurrence or metastasis of NPC patients.
This study will focus on the NPC highly expressed EBV antigen such as LMP1, LMP2 and EBNA1，the high affinity TCR target the above EBV antigen were screened from the healthy donor using the sorting and single cell cloning technique. Then, using the lentivirus to transduce the TCR gene to the autologous T cells.
This study will investigate the safety and tolerability of EBV-TCR-T cell therapy in subjects with NPC who had received prior therapy for their disease but their disease has progressed or relapsed.
The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used for lymphodepletion in immunotherapy clinical trials.

开始日期2018-10-10

申办/合作机构

福建省肿瘤医院

[+1]

NCT02333292 / CompletedN/AIIT

Efficacy and Safety of Treatment Against Hepatitis C Virus Infection Based on Direct-acting Antivirals in Real-life Conditions: The GEHEP Cohort

Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who show sustained virologic response (SVR) to treatment including direct-acting antivirals (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to determine the frequency of adverse events, including those that are severe and/or cause treatment interruption, in DAA-based therapy in this setting.
Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology (SEIMC).
Study population: HCV-monoinfected patients that initiate DAA-based treatment outside clinical trials.
Variables: The primary efficacy outcome variable is the proportion of patients who reach undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety outcome variable is the percentage of subjects who discontinue therapy due to adverse events.
Statistical analysis: A descriptive study will be performed, as well as a double sensibility analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment approach. Those variables that are associated with SVR12 with a p-value <0.2 will be included in a logistic regression analysis in which SVR12 will be the dependent variable.

开始日期2014-12-01

申办/合作机构

Hospital Universitario de Canarias

[+7]

100 项与 EBV TCR T cell therapy (China Immunotech) 相关的临床结果

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100 项与 EBV TCR T cell therapy (China Immunotech) 相关的转化医学

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项与 EBV TCR T cell therapy (China Immunotech) 相关的文献（医药）

1996-10-01·Archives of biochemistry and biophysics3区 · 生物学

Isolation and Characterization of Novel Long-Chain Acyl-CoA Thioesterase/Carboxylesterase Isoenzymes fromCandida rugosa

3区 · 生物学

Article

作者: Margareta A. Diczfalusy ; Stefan E.H. Alexson

Long-chain acyl-CoA thioesterases, which catalyze the cleavage of acyl-CoA's to free fatty acids and CoASH, are abundant in animal cells. However, in yeast little is known about presence and function of acyl-CoA thioesterase activity. Therefore a commercial lipase preparation from the yeast Candida rugosa was investigated and found to contain high myristoyl-CoA thioesterase activity. Hydrophobic interaction chromatography separated the activity into three peaks, of which two enzymes (YTE-1 and YTE-2) were purified to apparent homogeneity with molecular masses of about 40 kDa as determined by size-exclusion chromatography and SDS-PAGE. The employed purification protocol resulted in final preparations with specific activities of about 90 micromol/mg/min with myristoyl-CoA as substrate. YTE-1 and YTE-2 showed similar kinetic properties and YTE-1 was characterized in detail. Acyl-CoA chain-length specificity showed that YTE-1 was not active on acyl-CoAs shorter than decanoyl-CoA, at the substrate concentrations tested. The best substrates were C14-C18 acyl-CoAs with Vmax values of about 150 micromol/mg/min and Km values of 15-46 microM. The enzyme was very active with lauroyl-CoA (Vmax about 400 micromol/mg/min) although the Km was high (about 325 microM). The purified enzyme was also active on short-chain nitrophenyl esters but inactive with tributyrin. Treatment of the protein with N-glycosidase F decreased the molecular mass about 1-2 kDa, indicating the presence of carbohydrate of the high mannose type. Diisopropyl fluorophosphate (DFP) inhibited the enzyme activity efficiently and the protein was covalently labeled with [3H]DFP. p-Chloromercuribenzoic acid inhibited the thioesterase activity but did not affect carboxylesterase activity. N-terminal sequence analysis and labeling by DFP suggest that these long-chain acyl-CoA thioesterases belong to a novel group of yeast serine esterases.

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2024-03-28

·药明康德

▎药明康德内容团队编辑今日，Moderna公司召开了疫苗日（vaccine day）活动，公布了该公司在mRNA疫苗领域的研发布局和最新进展。该公司首席执行官Stéphane Bancel先生表示，未来3年多款疫苗产品有望上市，其中预防呼吸道合胞病毒（RSV）的mRNA疫苗有望在今年获得FDA的批准。同时，该公司宣布与Blackstone Life Sciences达成合作，获得7.5亿美元投资支持其流感疫苗的研发项目。今天这篇文章里，药明康德内容团队将与读者分享疫苗日上的精彩内容，点击文末“阅读全文/Read more“，即可下载研发日PPT报告。爱泼斯坦·巴尔病毒、带状疱疹病毒、诺如病毒疫苗获积极临床结果Moderna疫苗开发的重心之一是针对潜伏病毒的疫苗开发，这些病毒在急性感染之后会一直潜伏在体内，在人体免疫系统削弱的时候，潜伏的病毒可能再度爆发。潜伏的病毒也可能提高其它疾病的风险，比如爱泼斯坦·巴尔病毒（Epstein Barr virus，EBV），它不但显著提高感染者患上多发性硬化（MS）的风险，还与多种癌症相关。Moderna公司的EBV候选疫苗mRNA-1189编码4种EBV病毒抗原，在1期临床试验中，接种参与者激发的针对性抗体水平高于受到自然EBV感染后的抗体水平。此外，与安慰剂相比，接种mRNA-1189的参与者唾液中的病毒水平有所下降。Moderna计划进一步开发mRNA-1189，推动这一研发项目进入关键性临床试验阶段。▲Moderna公司的EBV候选疫苗简介（图片来源：Moderna官网）水痘带状疱疹病毒（VZV）是在老年人群中导致带状疱疹的主要原因，这种潜伏病毒在老年人免疫力下降后再度激活，感染神经元，造成严重的瘙痒和疼痛。今日公布的1/2期临床试验最新结果显示，两剂mRNA疫苗mRNA-1468接种可以激发VZV抗原特异性CD4阳性T细胞和CD8阳性T细胞反应。激发的T细胞反应与已经获批的带状疱疹疫苗相似。Moderna计划将这款疫苗推进至关键性3期临床试验。诺如病毒（norovirus）是导致腹泻的首要原因之一，在全球范围内与18%的急性胃肠炎相关。在1期临床试验中，单剂诺如病毒疫苗mRNA-1403的接种激发强力的抗体反应。这款疫苗也将被推进至关键性3期临床试验。▲mRNA-1403疫苗接种激发强力抗体反应（图片来源：Moderna官网）人工智能辅助疫苗研发在疫苗日上，Moderna公司还特别展示了人工智能（AI）辅助疫苗研发的效果。该公司的Dose ID GPT是一种生成式AI系统，可以通过分析已有临床数据推荐最佳接种剂量，更好地平衡激发强力免疫反应和保障疫苗的安全性。▲Moderna公司的生成式人工智能系统可用于在疫苗开发过程中推荐最佳接种剂量（图片来源：Moderna公司官网）该公司计划使用Dose ID GPT系统辅助多个研发项目进入后期临床开发阶段，包括上面提到的VZV、EBV、和诺如病毒疫苗。流感疫苗达到3期临床主要终点，7.5亿美元助力开发和商业化Moderna今日还宣布与Blackstone Life Sciences达成合作，获得7.5亿美元投资帮助流感疫苗的开发和商业化。该公司的流感疫苗mRNA-1010在3期临床试验P303中达到所有免疫原性共同主要终点。并且与已有疫苗相比，针对研究中四种病毒株的抗体滴度和血清转化率更高。Moderna计划在今年向监管机构递交这一疫苗的上市申请。▲mRNA-1010在3期临床试验P303中的免疫原性结果（图片来源：Moderna官网）Moderna公司在疫苗日上还介绍了多项研发项目，限于篇幅本文不做一一介绍，点击文末“阅读全文/Read more“，即可下载研发日PPT报告。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials. Retrieved March 27, 2024, from https://investors.modernatx.com/news/news-details/2024/Moderna-Advances-Multiple-Vaccine-Programs-to-Late-Stage-Clinical-Trials/default.aspx[2] Vaccine & Business Updates. Retrieved March 27, 2024, from https://s29.q4cdn.com/435878511/files/doc_events/2024/Mar/27/vaccines-day-2024_final_v5.pdf免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期信使RNA疫苗临床1期临床结果

100 项与 EBV TCR T cell therapy (China Immunotech) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
鼻咽肿瘤	临床2期	中国	华夏英泰（北京）生物技术有限公司初创企业	2018-10-10
埃博拉病毒性疾病	临床1期	中国	华夏英泰（北京）生物技术有限公司初创企业	2020-02-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ACTRIMS2022	N/A	髓鞘少突胶质细胞糖蛋白抗体相关疾病 MOG-IgG \| Aquaporin-4 Ab \| EBV viral PCR	1	IV methylprednisolone	鏇築範顧築選憲憲鑰構(選壓醖積網鑰蓋糧範艱) = elevated 鏇糧鹽壓積鑰艱積鏇窪 (廠蓋艱鹹選鹹齋餘壓繭 ) 更多	积极	2022-05-16