CMB-305(CMB-305) - 药物靶点：NY-ESO-1_专利_临床

概要

基本信息

药物类型

通用抗原疫苗、治疗性疫苗

别名

+ [4]

靶点

NY-ESO-1

作用机制

NY-ESO-1抑制剂(肿瘤/睾丸抗原-1抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病其他疾病+ [3]

在研适应症-

非在研适应症

局部晚期软组织肉瘤黑色素瘤粘液样脂肪肉瘤+ [3]

原研机构

Immune Design Corp.

在研机构-

非在研机构

Immune Design 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

2

项与 CMB-305 相关的临床试验

NCT02609984 / Terminated临床2期

A Randomized, Open-Label, Phase 2 Trial of CMB305 (Sequentially Administered LV305 and G305) and Atezolizumab in Patients With Locally Advanced, Relapsed, or Metastatic Sarcoma Expressing NY-ESO-1

This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 which is a dendritic cell-targeting viral vector expressing the New York Esophageal Squamous Cell Carcinoma 1 gene [NY-ESO-1] and G305 which is a NY-ESO-1 recombinant protein plus glucopyranosyl lipid adjuvant-stable emulsion [GLA-SE]) in combination with atezolizumab or atezolizumab alone, in participants with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein.
There is no formal primary hypothesis for this study.

开始日期2015-04-29

申办/合作机构

Genentech, Inc.

NCT02387125 / Terminated临床1期

A Phase 1b Study Evaluating the Safety, Tolerability and Immunogenicity of CMB305 (Sequentially Administered LV305 and G305) in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1.

开始日期2015-02-28

申办/合作机构-

100 项与 CMB-305 相关的临床结果

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100 项与 CMB-305 相关的转化医学

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100 项与 CMB-305 相关的专利（医药）

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3

项与 CMB-305 相关的文献（医药）

2022-04-20·Journal of Clinical Oncology1区 · 医学

Phase II Randomized Study of CMB305 and Atezolizumab Compared With Atezolizumab Alone in Soft-Tissue Sarcomas Expressing NY-ESO-1

1区 · 医学

Article

作者: Pollack, Seth M. ; Yakovich, Adam ; Keedy, Vicki L. ; Chen, Michael ; Attia, Steven ; Choy, Edwin ; Agulnik, Mark ; Van Tine, Brian A. ; Yurasov, Sergey ; von Mehren, Margaret ; Chawla, Sant P. ; Verschraegen, Claire F. ; Okuno, Scott H. ; Bohac, G. Chet ; Elias, Anthony D. ; Riedel, Richard F. ; Lu, Hailing ; Livingston, Michael B. ; Maki, Robert G. ; Ganjoo, Kristen N. ; Philip, Tony

PURPOSE CMB305 is a heterologous prime-boost vaccination regimen created to prime NY-ESO-1–specific CD8 T-cell populations and then activate the immune response with a potent TLR-4 agonist. This open-label randomized phase II trial was designed to investigate the efficacy and safety of adding the CMB305 regimen to atezolizumab (anti–programmed death ligand-1 therapy) in comparison with atezolizumab alone in patients with synovial sarcoma or myxoid liposarcoma. PATIENTS AND METHODS Patients with locally advanced, relapsed, or metastatic synovial sarcoma or myxoid liposarcoma (any grade) were randomly assigned to receive CMB305 with atezolizumab (experimental arm) or atezolizumab alone (control arm). The primary end points were progression-free survival (PFS) and overall survival (OS) analyzed using the Kaplan-Meier method. Safety and immune responses were assessed. RESULTS A total of 89 patients were enrolled; 55.1% had received ≥ 2 prior lines of chemotherapy. Median PFS was 2.6 months and 1.6 months in the combination and control arms, respectively (hazard ratio, 0.9; 95% CI, 0.6 to 1.3). Median OS was 18 months in both treatment arms. Patients treated with combination therapy had a significantly higher rate of treatment-induced NY-ESO-1–specific T cells ( P = .01) and NY-ESO-1–specific antibody responses ( P < .0001). In a post hoc analysis of all dosed patients, OS was longer (36 months) in the subset who developed anti-NY-ESO-1 T-cell immune response (hazard ratio, 0.3; P = .02). CONCLUSION Although the combination of CMB305 and atezolizumab did not result in significant increases in PFS or OS compared with atezolizumab alone, some patients demonstrated evidence of an anti-NY-ESO-1 immune response and appeared to fare better by imaging than those without such an immune response. Combining prime-boost vaccines such as CMB305 with anti–programmed death ligand-1 therapies merits further evaluation in other clinical contexts.

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.

Expert Review of Vaccines2区 · 医学

The potential of the CMB305 vaccine regimen to target NY-ESO-1 and improve outcomes for synovial sarcoma and myxoid/round cell liposarcoma patients

2区 · 医学

Review

作者: Pollack, Seth M.

INTRODUCTIONSynovial Sarcoma (SS) and Myxoid Round Cell Liposarcoma (MRCL) are devastating sarcoma subtypes with few treatment options and poor outcomes in the advanced setting. However, both these diseases may be ideal for novel immunotherapies targeting the cancer-testis antigen, NY-ESO-1.AREAS COVEREDIn this review, we discuss the novel NY-ESO-1 targeted vaccine regimen, CMB305. This regimen uses a unique integration-deficient, dendritic-cell targeting lentiviral vector from the ZVex® platform, LV305, in order to prime NY-ESO-1 specific T cells. LV305 has single agent activity, and, in one case, caused a durable partial response in a refractory SS patient. CMB305 also includes a boost from a NY-ESO-1 protein vaccine given along with a potent toll-like-4 receptor agonist, glycopyranosyl lipid A. CMB305 induces NY-ESO-1 specific T cell responses in both SS and MRC patients and these patients had excellent overall survival (OS) outcomes in the initial phase I study.EXPERT COMMENTARYCMB305 is a therapeutic vaccine regimen targeting NY-ESO-1 based on the lentiviral vaccine vector, LV305. Phase I studies have proven this vaccine is active immunologically. Data suggesting this vaccine may improve OS for SS and MRCL patients is exciting but early, and on-going work is testing the impact of CMB305 on patient outcomes.

100 项与 CMB-305 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
滑膜肉瘤	临床3期	美国	Immune Design Corp.	2018-06-21
滑膜肉瘤	临床3期	美国	Immune Design Corp.	2018-06-21
局部晚期软组织肉瘤	临床3期	美国	-	2015-04-29
粘液样脂肪肉瘤	临床3期	美国	-	2015-04-29
黑色素瘤	临床3期	美国	-	2015-02-28
非小细胞肺癌	临床3期	美国	-	2015-02-28
卵巢癌	临床3期	美国	-	2015-02-28

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02387125 (Pubmed \| Oncoimmunology) 人工标引	临床1期	局部晚期恶性肿瘤	79	cyclophosphamide+glucopyranosyl lipid A+CMB305	(鏇鏇膚選襯網遞顧顧繭) = fatigue (34.2%), nausea (26.6%), and injection-site pain (24.1%) 範鬱獵獵艱鑰襯觸糧製 (廠遞鹽壓獵願網網觸遞 )	积极	2020-11-19
NCT02609984 (V943A-002 \| IMDZ-C232, CTgov)	临床2期	局部晚期软组织肉瘤 \| 滑膜肉瘤 \| 粘液样脂肪肉瘤	89	Atezolizumab+CMB305 (CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab)	餘糧積鹹遞繭獵築廠餘(觸鹹夢夢鏇繭製鹹鹹願) = 鏇糧繭廠簾齋糧範膚憲築積蓋願憲憲壓齋鹹淵 (艱積餘膚膚選齋鏇繭淵, 糧憲淵鏇鑰遞簾餘觸簾 ~ 繭繭積鏇願願衊鹽夢積) 更多	-	2020-05-14
NCT02609984 (V943A-002 \| IMDZ-C232, CTgov)	临床2期	局部晚期软组织肉瘤 \| 滑膜肉瘤 \| 粘液样脂肪肉瘤	89	Atezolizumab (Atezolizumab)	餘糧積鹹遞繭獵築廠餘(觸鹹夢夢鏇繭製鹹鹹願) = 壓壓築齋衊糧廠簾構艱築積蓋願憲憲壓齋鹹淵 (艱積餘膚膚選齋鏇繭淵, 衊選簾獵網觸艱憲窪廠 ~ 觸獵膚蓋觸窪築窪餘遞) 更多	-	2020-05-14
NCT02609984 (V943A-002 \| IMDZ-C232, ASCO2019) 人工标引	临床2期	肉瘤 \| 粘液样脂肪肉瘤 CTAG1B Positive	88	atezolizumab+CMB305	(範願醖鹽積顧鹹鹹鹽獵) = 膚簾廠窪簾廠壓夢簾蓋壓範夢糧鹽壓簾襯鏇壓 (膚構淵鬱鹹製願範繭衊, 11.0 ~ NR) 更多	积极	2019-05-26
NCT02609984 (V943A-002 \| IMDZ-C232, ASCO2019) 人工标引	临床2期	肉瘤 \| 粘液样脂肪肉瘤 CTAG1B Positive	88	atezolizumab	(範願醖鹽積顧鹹鹹鹽獵) = 選繭構築網糧廠淵顧範壓範夢糧鹽壓簾襯鏇壓 (膚構淵鬱鹹製願範繭衊, 4.6 ~ 26.1) 更多	积极	2019-05-26
NCT02387125 (ESMO2018)	临床1期	软组织肉瘤维持	25	CMB305 regimen	窪築醖願鬱鬱蓋構餘簾(觸醖鑰醖鹹構鬱構鏇範) = Most treatment related adverse events were Grade 1 or 2; one Grade 3 (prostatic pain); no grade 4 or 5 events. 製餘餘艱壓願鑰齋鏇鬱 (夢夢夢鹹鹹選膚遞顧鑰 ) 更多	积极	2018-10-22
Phase 1 trials of LV305 and CMB305 (ASCO2017)	临床1期	肿瘤	62	CMB305	壓鑰醖觸願觸夢餘鏇衊(糧製醖糧構範觸醖觸齋) = 齋觸願淵築憲遞構蓋鹹鏇獵簾範構窪廠醖積簾 (顧網齋膚範製積網壓襯 ) 更多	-	2017-05-30
Phase 1 trials of LV305 and CMB305 (ASCO2017)	临床1期	肿瘤	62	LV305	壓鑰醖觸願觸夢餘鏇衊(糧製醖糧構範觸醖觸齋) = 願窪壓醖遞觸鑰繭繭窪鏇獵簾範構窪廠醖積簾 (顧網齋膚範製積網壓襯 ) 更多	-	2017-05-30
NCT02387125 (CMB305, ASCO2017)	临床1期	软组织肉瘤	25	CMB305	鑰鑰構鏇鹽範夢夢淵顧(餘顧壓膚糧願衊構繭網) = 觸糧製衊願鑰範築觸蓋蓋願範範願窪觸鹹網網 (鬱膚衊衊簾夢夢範製網 ) 更多	-	2017-05-30