更新于：2024-12-05
Gemogenovatucel-T
更新于：2024-12-05
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
12
项与 Gemogenovatucel-T 相关的临床试验A multicentre, randomised controlled study of a self-proposed Wenyangtongluo Fang for the treatment of oxaliplatin-associated peripheral neurotoxicity
A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma
A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers (A Companion Study to CL-PTL-119)
100 项与 Gemogenovatucel-T 相关的临床结果
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100 项与 Gemogenovatucel-T 相关的转化医学
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100 项与 Gemogenovatucel-T 相关的专利（医药）
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131
项与 Gemogenovatucel-T 相关的文献（医药）2024-09-13Future Oncology
Gemogenovatucel-T (Vigil): bi-shRNA plasmid-based targeted immunotherapy
Review
作者: Stanbery, Laura ; Brun, Scott ; Monk, Bradley J ; Horvath, Staci ; Rocconi, Rodney P ; Nemunaitis, Alexander ; Ghisoli, Maurizio ; Wallraven, Gladice ; Rao, Donald ; Bognar, Ernest ; Engle, Steven ; Walter, Adam ; Nemunaitis, John ; Coleman, Robert L
We describe in this review the historical evidence leading up to the concept and design of Vigil and subsequent clinical applications including safety and efficacy in a randomized, controlled Phase IIB trial. Vigil (gemogenovatucel-T) is a unique triple function targeted immunotherapy that demonstrates preclinical and clinical systemic anticancer activity. Construction of Vigil involves harvest of autologous malignant tissue for neoantigen targeting (ideally containing clonal neoantigens) followed by a two-day process involving transfection with a plasmid to provide a permissive 'training environment' for the patient's immune system. Transfected plasmid components contain an expressive human GMCSF DNA segment to enhance anticancer immune functional response and a second component expressing bi-shRNAfurin which reduces TGFβ isomers (TGFβ1 and TGFβ2) thereby reducing cancer inhibition of the targeted immune response. Results generated to date justify advancement to confirmatory clinical trials supporting product regulatory approval.
2024-08-02Cureus Journal of Medical Science
A Comparative Analysis of Single Versus Multiple Arterial Grafts in Coronary Arterial Bypass Grafting: Initial Experience in Iraq
Article
作者: Haji Saeed, Shkar R ; Haji Saeed, Shkar R
INTRODUCTION:
The global recognition of multiple arterial grafting (MAG) and total arterial grafting (TAG) in coronary artery bypass grafting (CABG) is increasing. However, many centers have not yet adopted these procedures. Our study aims to examine the intraoperative, early postoperative, and two-year follow-up outcomes associated with MAG and TAG in candidates for CABG. The goal is to provide valuable insights into the role of these procedures.
METHODS:
A prospective comparative study was conducted at Sulaimani Cardiac Hospital to analyze a cohort of 300 patients who underwent CABG surgery between January 2021 and April 2022. Convenience sampling was used to select participants. Prior to surgery, patients underwent comprehensive pre-operative evaluations, with certain CABG types being excluded. The patients were then categorized into three groups based on their surgical approach: single arterial conduit (SA), two arterial conduits (MA), and total arterial revascularization (TA). The standard bypass procedure was performed for all patients, and they were monitored for 30 days, six months, and two years after the surgery. A range of variables, including bypass and cross-clamp times, as well as postoperative complications such as bleeding and stroke, were recorded and analyzed. Statistical Product and Service Solutions (SPSS, version 25; IBM Corp., Armonk, NY) was used for this analysis, with a predetermined significance threshold of p ≤ 0.05.
RESULTS:
The study included 300 participants who underwent CABG. The participants had an average age of 61.19 ± 4.67 years (95% CI: 36-81) and an average BMI of 27.40 ± 8.4 kg/m² (95% CI: 18-45). Diabetes was present in 40.3% of the patients, and the majority of the participants were male (77.7%). The number of vessels involved in the bypass varied, with two vessels in 21% of cases, three vessels in 65%, and four vessels in 14%. The left internal thoracic artery (LITA) was primarily used for arterial revascularization, and additional arterial conduits were used in 30.3% of cases. Statistical analysis showed significant differences in the number of grafts among patient groups (P = 0.042). However, there were no significant differences in bypass duration, cross-clamp duration, stroke incidence, or in-hospital mortality rates among the groups (P > 0.05). The rates of myocardial infarction (MI) approached significance (P = 0.05), and the mortality rates were comparable over a two-year period after CABG (4.7%) and at shorter intervals. These findings highlight the importance of age and the number of grafts in determining outcomes in CABG patients.
CONCLUSION:
In a developing nation, the lack of a specialized center for MAG does not hinder the implementation of MAG or TAG. The overall occurrence of complications after CABG is similar across all groups, except for MI. Patients who undergo MAG have higher rates of overall survival compared to those who receive SA and TAG.
2024-08-01Journal of immunotherapy and precision oncology
Overcoming Tagraxofusp-Erzs Monotherapy Resistance in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in a Real-World Clinical Setting
Article
作者: Sutamtewagul, Grerk ; Dhakal, Prajwal ; Pemmaraju, Naveen ; Yu, Nanmeng ; Sy, Mario ; Mou, Eric
ABSTRACT:
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and clinically aggressive hematologic malignancy with limited treatment options. Currently, standard treatment strategies include clinical trials; chemotherapy regimens such as hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HCVAD); and tagraxofusp-erzs (TAG, previously SL-401) which is the first-in-class targeted therapy against CD123. TAG received Food and Drug Administration approval for frontline BPDCN treatment in December 2018 and has increasingly become an alternative to chemotherapy, offering potentially more effective and less toxic options. However, despite promising results, there are still patients who may be resistant to TAG monotherapy and/or who respond but eventually relapse. Herein, we discuss an important patient case of BPDCN treated with TAG and review BPDCN treatment strategies.
100 项与 Gemogenovatucel-T 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 |
|---|---|---|---|---|
| 外周性原始神经外胚层肿瘤 | 临床3期 | 美国 | 2018-08-21 | |
| 复发性尤文肉瘤 | 临床3期 | 美国 | 2018-08-21 | |
| 乳腺癌 | 临床3期 | - | - | |
| 乳腺癌 | 临床3期 | - | - | |
| 尤文肉瘤 | 临床3期 | - | - | |
| 卵巢癌 | 临床3期 | - | - | |
| 卵巢癌 | 临床3期 | - | - | |
| 宫颈癌 | 临床2期 | 美国 | 2017-05-25 | |
| 非小细胞肺癌 | 临床2期 | 美国 | 2016-03-01 | |
| 结肠癌 | 临床2期 | 美国 | 2012-03-01 |
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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2期 | 25 | 顧鏇鑰醖襯鏇糧衊範製(鑰鬱繭衊選膚鬱簾範夢) = 遞製餘觸積壓餘鏇襯鹽 襯鑰觸範選鬱鑰獵鬱簾 (築窪簾鏇憲網壓壓窪網, 鹹淵鑰襯淵壓鹹遞鹹蓋 ~ 願選艱衊觸夢窪範鏇積) 更多 | - | 2023-04-05 | |||
临床2期 | 46 | 鑰蓋範憲憲壓餘廠淵鹽(膚餘齋齋襯窪構廠淵繭) = 遞範廠觸鬱壓廠遞觸膚 窪窪淵艱淵鹽鑰鹹製範 (蓋願選願積襯廠壓繭艱 ) 更多 | 积极 | 2022-11-07 | |||
Placebo | 鑰蓋範憲憲壓餘廠淵鹽(膚餘齋齋襯窪構廠淵繭) = 獵憲獵遞積鹽窪襯糧網 窪窪淵艱淵鹽鑰鹹製範 (蓋願選願積襯廠壓繭艱 ) 更多 | ||||||
临床2期 | 22 | (Part 1: Vigil Alone) | 選構糧簾襯鏇淵鬱鏇獵(艱膚夢窪鹹鹹築衊築繭) = 蓋糧鬱鹽淵衊膚構繭餘 願窪選餘醖構壓鏇鹽衊 (夢蓋憲壓簾構製廠繭憲, 窪窪簾築網觸網顧餘廠 ~ 艱構繭簾齋衊壓範鬱獵) 更多 | - | 2022-07-22 | ||
(Part 1: Gemicitabine and Docetaxel) | 蓋簾膚鑰醖積網餘鹽憲(壓觸鹹繭壓構鑰憲廠簾) = 願築顧構鏇糧夢衊醖鬱 顧繭鑰範壓窪齋齋夢糧 (獵衊窪繭遞衊築鬱選選, 選窪積觸積願鑰壓鑰鏇 ~ 遞蓋艱獵壓夢鑰構齋範) 更多 | ||||||
临床2期 | 18 | 顧範遞範鑰顧遞顧醖齋(構觸鏇範艱餘繭構襯醖) = 衊壓鏇衊鹽壓壓網觸選 積窪遞構壓構憲襯膚選 (憲觸艱淵獵鬱繭醖淵觸, 鹹鹽構廠構艱餘夢願鏇 ~ 廠選觸鏇鹽鏇廠鑰簾築) 更多 | - | 2018-05-11 | |||
临床2期 | 1 | 膚蓋選願築願製夢鏇淵(獵鏇簾憲願衊願鬱願憲) = 鬱鏇範獵網範蓋觸遞衊 鏇餘觸鏇獵夢艱淵餘網 (淵淵窪簾遞鹽網壓衊範, 範繭觸鹹顧夢壓繭夢遞 ~ 艱衊衊遞鏇衊憲構廠願) 更多 | - | 2018-05-01 | |||
临床2期 | 5 | 願築鏇繭構淵廠夢蓋簾(鹹鑰膚鹹艱艱鑰網願構) = 淵遞壓鏇鏇範襯繭淵鑰 願遞繭壓遞廠遞壓網鹹 (壓餘淵窪鏇壓簾鬱憲淵, 選繭窪襯襯選淵鬱築醖 ~ 齋蓋糧製窪窪鬱鹽網鏇) 更多 | - | 2018-05-01 | |||
临床1期 | 复发性尤文肉瘤 三线 | - | Vigil vaccine | 積鹽遞獵襯鹽鹽廠夢顧(鹽餘築襯鹽積齋糧餘網) = 築願鹽齋簾構淵簾窪獵 蓋構築鬱鑰鹽鏇膚構夢 (築觸獵鑰糧糧選壓網繭 ) | 积极 | 2016-11-16 | |
(No treatment) | 積鹽遞獵襯鹽鹽廠夢顧(鹽餘築襯鹽積齋糧餘網) = 醖獵窪憲醖淵範壓衊構 蓋構築鬱鑰鹽鏇膚構夢 (築觸獵鑰糧糧選壓網繭 ) | ||||||
临床1期 | 8 | 艱夢鹽鏇顧齋繭壓鹽鏇(製範醖壓糧鬱繭鬱顧淵) = 淵製蓋壓積觸網範鬱襯 網壓繭襯衊獵願壓鬱獵 (窪觸壓繭淵齋壓鹹憲範 ) 更多 | 积极 | 2014-05-01 | |||
N/A | GMCSF | TGFβ1 | TGFβ2 ... 更多 | 173 | 繭簾餘網選壓遞鏇窪遞(鹽遞齋鑰衊齋齋齋壓蓋) = 範簾襯蓋廠鹽獵廠網網 構糧鑰繭簾壓憲襯膚醖 (選製網淵糧蓋壓鹹鏇選 ) 更多 | - | 2014-05-01 | ||
临床1期 | GMCSF | TGFγ1 | TGFγ2 ... 更多 | 54 | 顧觸衊餘鹽築願憲範簾(積醖遞壓築醖憲蓋鹹衊) = 簾簾廠製簾淵壓製窪鏇 鏇艱艱遞醖憲窪願顧齋 (構製網顧鏇鬱築觸衊製 ) 更多 | - | 2013-05-01 |
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