A Phase 1/2, Proof-of-Principle, Multi-Center, Open-Label, Single-Arm, Non-randomized Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine Consisting of Genetically Modified Allogeneic (Human) Tumor Cells for the Expression of IL-7, GM-CSF, CD80 and CD154, in Fixed Combination With a DNA-based Double Stem Loop Immunomodulator in Patients With Advanced Renal Cell Carcinoma (ASET Study)

This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients with advanced renal cell carcinoma.

开始日期2010-11-01

申办/合作机构

Mologen AG

100 项与 MGN-1601 相关的临床结果

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100 项与 MGN-1601 相关的转化医学

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100 项与 MGN-1601 相关的专利（医药）

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项与 MGN-1601 相关的文献（医药）

2024-02-01·Reviews on Recent Clinical Trials

A Review of Clinical Trials of Cancer and Its Treatment as a Vaccine

Review

作者: Chandarana, Chandani ; Tiwari, Anuradha

Background:Cancer and infectious diseases are one of the greatest challenges of modern medicine. An unhealthy lifestyle, poor drug use, or drug misuse contribute to the rise in morbidity and mortality brought on by these illnesses. The inadequacies of the medications now being used to treat these disorders, along with the growing issue of drug resistance, have compelled researchers to look for novel compounds with therapeutic promise. The number of infections and diseases has significantly abated due to vaccine development and use over time, which is described in detail. Several novel vaccines can now be produced by manipulating Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), Messenger Ribonucleic acid (mRNA), proteins, viral vector Recombinant, and other molecules due to advances in genetic engineering and our understanding of the immune defense.Objective:The main topic of discussion is cancer-based vaccinations, which were developed less than a decade ago but have already been used to treat a wide range of both life-threatening and deadly diseases. It contains clinical studies for cancer vaccines against kidney, liver, prostate, cervix, and certain RNA-based cancer vaccines against breast and bladder cancer.Results:Numerous studies using various DNA and RNA-based methods have been conducted on the basis of cancer, with 9-10 diseases related to DNA and 8–9 diseases associated with RNA. Some of these studies have been completed, while others have been eliminated due to a lack of research; further studies are ongoing regarding the same.Conclusion:This brief discussion of vaccines and their varieties with examples also discusses vaccine clinical trials in relation to cancer diseases in this DNA and RNA-based cancer vaccine that has had successful clinical trials like the cervical cancer drug VGX-3100, the kidney cancer drug Pembrolizumab, MGN-1601, the prostate cancer drug pTVG-HP with rhGM-CSF, the melanoma cancer drug proteasome siRNA, and the lung cancer drug FRAME-001.

2016-01-01·Molecular Therapy - Oncolytics2区 · 医学

Design and characterization of the tumor vaccine MGN1601, allogeneic fourfold gene-modified vaccine cells combined with a TLR-9 agonist

2区 · 医学

ArticleOA

作者: Volz, Barbara ; Wittig, Burghardt ; Heinrich, Kerstin ; Schroff, Matthias ; Kapp, Kerstin ; Schmidt, Manuel

The tumor vaccine MGN1601 was designed and developed for treatment of metastatic renal cell carcinoma (mRCC). MGN1601 consists of a combination of fourfold gene-modified cells with the toll-like receptor 9 agonist dSLIM, a powerful connector of innate and adaptive immunity. Vaccine cells originate from a renal cell carcinoma cell line (grown from renal cell carcinoma tissue), express a variety of known tumor-associated antigens (TAA), and are gene modified to transiently express two co-stimulatory molecules, CD80 and CD154, and two cytokines, GM-CSF and IL-7, aimed to support immune response. Proof of concept of the designed vaccine was shown in mice: The murine homologue of the vaccine efficiently (100%) prevented tumor growth when used as prophylactic vaccine in a syngeneic setting. Use of the vaccine in a therapeutic setting showed complete response in 92% of mice as well as synergistic action and necessity of the components. In addition, specific cellular and humoral immune responses in mice were found when used in an allogeneic setting. Immune response to the vaccine was also shown in mRCC patients treated with MGN1601: Peptide array analysis revealed humoral CD4-based immune response to TAA expressed on vaccine cells, including survivin, cyclin D1, and stromelysin.

100 项与 MGN-1601 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
晚期肾细胞癌	临床2期	德国	Mologen AG	2010-11-01

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临床结果

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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


NCT01265368 (ASET, ASCO2014)	临床1/2期	转移性肾细胞癌	19	MGN1601	(願壓積繭鏇觸壓糧齋鑰) = 窪遞淵鑰築鬱餘繭齋選鏇網淵糧艱艱襯顧繭衊 (齋襯壓窪衊築蓋艱窪觸 )	-	2014-05-20
NCT01265368 (ASET, ASCO_GU2013)	临床1/2期	转移性肾细胞癌	19	MGN1601	(鏇壓襯醖網鹹範壓顧壓) = 夢廠選鑰願選餘夢觸鹽鹹襯網艱廠構壓夢選範 (壓糧廠壓壓願繭鹹簾艱 ) 更多	-	2013-02-20
ASET (ASCO_GU2012)	临床1/2期	转移性肾细胞癌	-	MGN1601	(範鬱廠簾鹹鬱網繭糧衊) = 鹹襯繭觸憲艱網願構網醖觸餘糧壓鏇構鬱鹹鹹 (鹹窪構襯餘選構選窪觸 )	积极	2012-02-10