Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.)(Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.))

概要

基本信息

药物类型

通用抗原疫苗、治疗性疫苗

别名

Cancer vaccine DCVex NY-ESO-1、DCVex/NY-ESO-1 cancer vaccine

+ [3]

靶点

NY-ESO-1

作用机制

CD8B 抑制剂(CD8b molecule inhibitors)、NY-ESO-1抑制剂(肿瘤/睾丸抗原-1抑制剂)、免疫刺激剂

治疗领域

肿瘤皮肤和肌肉骨骼疾病其他疾病+ [1]

在研适应症-

非在研适应症

黑色素瘤非小细胞肺癌肉瘤+ [2]

原研机构

Immune Design Corp.

在研机构-

非在研机构

Immune Design Corp.

Merck Sharp & Dohme Corp.

最高研发阶段终止临床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

3

项与 Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.) 相关的临床试验

NCT03520959 / Terminated临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1+ Synovial Sarcoma Participants Following First Line Systemic Anti-cancer Therapy (V943-003, IMDZ-04-1702)

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

开始日期2018-09-18

申办/合作机构

Immune Design Corp.

NCT03450122 / Completed临床1期IIT

Phase I Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ NYESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 for Patients With Sarcoma

This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes [T cells]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating participants with sarcoma that has spread to other places in the body (advanced) or that has come back (recurrent). Modified T cells used in this study are taken from participants, are changed in a laboratory, and may "kill" some types of tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide may help the body get ready to receive the modified T cells. Interleukins, such as aldesleukin, are proteins made by white blood cells and other cells in the body and may help regulate immune response. LV305 and CMB305 may help stimulate the immune system. Giving modified T cells, chemotherapy, aldesleukin, LV305, and CMB305 may work better in treating participants with sarcoma.

开始日期2018-09-13

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT02122861 / Completed临床1期

A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.

开始日期2014-05-30

申办/合作机构

Immune Design Corp.

[+1]

100 项与 Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.) 相关的临床结果

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100 项与 Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.) 相关的转化医学

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100 项与 Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.) 相关的专利（医药）

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5

项与 Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.) 相关的文献（医药）

2020-01-01·OncoImmunology2区 · 医学

A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

2区 · 医学

ArticleOA

作者: Chen, Michael ; Sankhala, Kamalesh K. ; Kenney, Richard T. ; Kim, Joseph W. ; Chawla, Sant P. ; Morris, John C. ; Kim-Schulze, Seunghee ; Lu, Hailing ; Yishak, Mahlet ; Block, Matthew S. ; Jones, Robin L. ; Do, Khanh ; Gnjatic, Sacha ; Yakovich, Adam ; Druta, Mihaela ; Ter Meulen, Jan ; Hwu, Patrick ; Bohac, Chet ; Tuballes, Kevin ; Somaiah, Neeta ; Pollack, Seth M.

Preclinical data suggest that a "prime-boost" vaccine regimen using a target-expressing lentiviral vector for priming, followed by a recombinant protein boost, may be effective against cancer; however, this strategy has not been evaluated in a clinical setting. CMB305 is a prime-boost vaccine designed to induce a broad anti-NY-ESO-1 immune response. It is composed of LV305, which is an NY-ESO-1 expressing lentiviral vector, and G305, a recombinant adjuvanted NY-ESO-1 protein. This multicenter phase 1b, first-in-human trial evaluated CMB305 in patients with NY-ESO-1 expressing solid tumors. Safety was examined in a 3 + 3 dose-escalation design, followed by an expansion with CMB305 alone or in a combination with either oral metronomic cyclophosphamide or intratumoral injections of a toll-like receptor agonist (glucopyranosyl lipid A). Of the 79 patients who enrolled, 81.0% had sarcomas, 86.1% had metastatic disease, and 57.0% had progressive disease at study entry. The most common adverse events were fatigue (34.2%), nausea (26.6%), and injection-site pain (24.1%). In patients with soft tissue sarcomas, a disease control rate of 61.9% and an overall survival of 26.2 months (95% CI, 22.1-NA) were observed. CMB305 induced anti-NY-ESO-1 antibody and T-cell responses in 62.9% and 47.4% of patients, respectively. This is the first trial to test a prime-boost vaccine regimen in patients with advanced cancer. This approach is feasible, can be delivered safely, and with evidence of immune response as well as suggestion of clinical benefit.

2019-10-01·Clinical Cancer Research1区 · 医学

First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1

1区 · 医学

Article

作者: Shapiro, Geoffrey I. ; Chen, Michael ; Block, Matthew S. ; Lu, Hailing ; Bohac, Chet ; Kim, Joseph W. ; Pollack, Seth M. ; Eder, Joseph P. ; Gnjatic, Sacha ; Hwu, Patrick ; Hsu, Frank J. ; Jones, Robin L. ; Somaiah, Neeta ; Do, Khanh T. ; ter Meulen, Jan H.

AbstractPurpose:LV305 is a modified, third-generation, nonreplicating, integration-deficient lentivirus-based vector designed to selectively transduce dendritic cells in vivo. LV305 induces expression of the New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) cancer testis antigen in dendritic cells, promoting immune responses against NY-ESO-1–expressing tumors. This phase I study evaluated the safety, immunogenicity, and preliminary efficacy of LV305 in patients with sarcoma or other solid tumors.Patients and Methods:Adults with previously treated, advanced, NY-ESO-1–positive solid tumors and limited tumor burden were eligible. LV305 was administered every 3 weeks by intradermal injection in four dose cohorts (Cohort 1: 108 vector genomes (vg) x 3 doses; Cohorts 1A, 2, and 3: 108 vg, 109 vg, 1010 vg x 4 doses).Results:Thirty-nine patients were enrolled: 3 patients each in Cohorts 1, 1A, and 2, and 30 patients in Cohort 3. No dose-limiting toxicities were observed. Tumor types included sarcoma (n = 24), ovarian (n = 8), melanoma (n = 6), and lung cancer (n = 1). All treatment-related adverse events were grade 1 or 2. Common treatment-related adverse events were fatigue (49%), injection site reactions (46%), and myalgia (21%). The disease control rate was 56.4% in all patients and 62.5% in sarcoma patients. One patient with synovial sarcoma achieved a partial response lasting >36 months. Anti–NY-ESO-1-specific CD4+ and/or CD8+ T cells were induced in 57% of evaluable sarcoma patients. Induction of an anti–NY-ESO-1 immune response was associated with improved 1-year survival in an exploratory analysis.Conclusions:This first-in-class, first-in-human study of LV305 demonstrated a favorable safety profile, induction of antigen-specific responses, and potential clinical activity in patients with advanced cancer.

2017-10-01·Journal of Immunotherapy4区 · 医学

First-in-Human Treatment With a Dendritic Cell-targeting Lentiviral Vector-expressing NY-ESO-1, LV305, Induces Deep, Durable Response in Refractory Metastatic Synovial Sarcoma Patient

4区 · 医学

Article

作者: Jones, Robin L. ; Gnjatic, Sacha ; O’Malley, Ryan B. ; Lu, Hailing ; ter Meulen, Jan ; Pollack, Seth M. ; Somaiah, Neeta ; Hsu, Frank J.

Effective induction of antitumor T cells is a pivotal goal of cancer immunotherapy. To this end, lentiviral vectors (LV) are uniquely poised to directly prime CD8 T-cell responses via transduction of dendritic cells in vivo and have shown promise as active cancer therapeutics in preclinical tumor models. However, until now, significant barriers related to production and regulation have prevented their widespread use in the clinic. We developed LV305, a dendritic cell-targeting, integration-deficient, replication incompetent LV from the ZVex platform, encoding the full-length cancer-testis antigen NY-ESO-1. LV305 is currently being evaluated in phase 1 and 2 trials in metastatic recurrent cancer patients with NY-ESO-1 positive solid tumors as a single agent and in combination with anti-PD-L1. Here we report on the first patient treated with LV305, a young woman with metastatic, recurrent, therapy-refractive NY-ESO-1+ synovial sarcoma. The patient developed a robust NY-ESO-1-specific CD4+ and CD8+ T-cell response after 3 intradermal injections with LV305, and subsequently over 85% disease regression that is continuing for >2.5 years posttherapy. No adverse events >grade 2 occurred. This case demonstrates that LV305 can be safely administered and has the potential to induce a significant clinical benefit and immunologic response in a patient with advanced stage cancer.

100 项与 Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
软组织肉瘤	临床3期	美国	Immune Design Corp.	2018-09-18
软组织肉瘤	临床3期	加拿大	Immune Design Corp.	2018-09-18
滑膜肉瘤	临床3期	美国	Immune Design Corp.	2018-09-18
滑膜肉瘤	临床3期	加拿大	Immune Design Corp.	2018-09-18
黑色素瘤	临床3期	美国	Merck Sharp & Dohme Corp.	2014-05-30
非小细胞肺癌	临床3期	美国	Merck Sharp & Dohme Corp.	2014-05-30
肉瘤	临床3期	美国	Merck Sharp & Dohme Corp.	2014-05-30

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临床结果

适应症

分期

评价

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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


NCT03520959 (IMDZ-04-1702, CTgov)	临床3期	软组织肉瘤 \| 滑膜肉瘤	1	LV305-matching placebo (Placebo)	鹽艱網網醖蓋壓遞鹹鹽(憲鹹艱鹽範廠餘願範衊) = 繭鏇顧蓋願築夢醖網廠齋簾獵夢選鹹糧獵壓選 (淵繭簾憲鹽廠齋夢鏇遞, 獵繭夢襯衊醖遞夢繭憲 ~ 遞鹹糧鬱鏇願積築淵鹽) 更多	-	2020-04-16
				G305+LV305 (CMB305)	遞齋選簾鏇築齋獵製餘(齋襯鹽膚鏇繭願獵築築) = 網糧鹽遞蓋壓選積艱鬱壓窪願顧餘獵選鹹築糧 (獵艱憲願蓋鹽餘鹽鏇選, 網獵顧簾鹽網築襯顧餘 ~ 網鹹築觸範膚鏇顧觸構) 更多
Phase 1 trials of LV305 and CMB305 (ASCO2017)	临床1期	肿瘤	62	CMB305	糧製製憲窪簾簾齋窪遞(廠蓋夢鹽鹽獵製遞夢築) = 餘憲醖窪顧構糧網鑰觸膚鬱艱襯鬱網鏇繭網顧 (夢積鹽憲夢網網選窪廠 ) 更多	-	2017-05-30
				LV305	糧製製憲窪簾簾齋窪遞(廠蓋夢鹽鹽獵製遞夢築) = 壓觸遞積鏇壓範糧網衊膚鬱艱襯鬱網鏇繭網顧 (夢積鹽憲夢網網選窪廠 ) 更多
NCT02122861 (ASCO2016)	临床1期	肉瘤 \| 肿瘤	27	LV305	(夢淵醖積願壓構製鏇齋) = no DLT or SAEs were observed in the 12 sarcoma patients; all related AEs were grade 1/2 範壓鹽憲壓鑰鬱鑰獵鹽 (遞鬱繭廠選簾築選網鏇 ) 更多	积极	2016-05-20