CD40L-GVAX(University of South Florida)(CD40L-GVAX(University of South Florida)) - 药物靶点：CD40 x CSF-2R x GM-CSF_在研适应症：非小细胞肺癌_专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名

Autologous tumour cell-based vaccine、Bystander GVAX Cancer Vaccine、Bystander vaccine

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靶点

CD40 x CSF-2R x GM-CSF

作用机制

CD40激动剂(肿瘤坏死因子受体超家族成员5激动剂)、CSF-2R刺激剂(粒细胞 - 巨噬细胞集落刺激因子受体复合体刺激剂)、GM-CSF刺激剂(巨噬细胞集落刺激因子2刺激剂)

治疗领域

肿瘤呼吸系统疾病

在研适应症

非小细胞肺癌

非在研适应症

肺腺癌套细胞淋巴瘤皮肤黑色素瘤

原研机构

University of South Florida

在研机构

Cell Genesys, Inc.

非在研机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

最高研发阶段临床1/2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

5

项与 CD40L-GVAX(University of South Florida) 相关的临床试验

NCT02466568

/ Withdrawn临床1/2期IIT

A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung

The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.

开始日期2018-07-01

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

NCT01433172

/ Completed临床1/2期IIT

A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung

The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and after the vaccine treatment.

开始日期2012-03-26

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

NCT00840931

/ Completed临床1期IIT

A Phase I Pilot Study of Immunotherapy Using Lenalidomide Plus "Bystander" Vaccine in Patients With High-Risk Myelodysplastic Syndrome (MDS)

The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is also being done to see how well the combination of these drugs works to fight myelodysplastic syndrome (MDS).

开始日期2009-02-02

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

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100 项与 CD40L-GVAX(University of South Florida) 相关的临床结果

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100 项与 CD40L-GVAX(University of South Florida) 相关的转化医学

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100 项与 CD40L-GVAX(University of South Florida) 相关的专利（医药）

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82

项与 CD40L-GVAX(University of South Florida) 相关的文献（医药）

2020-09-07·Journal of Experimental Medicine1区 · 医学

Autologous tumor cell vaccine induces antitumor T cell immune responses in patients with mantle cell lymphoma: A phase I/II trial

1区 · 医学

Article

作者: Faham, Malek ; Moore, A. Holliston ; Frank, Matthew J. ; Weng, Wen-Kai ; Phillips, Destiny L. ; Wapnir, Irene L. ; Meyer, Everett H. ; Laport, Ginna G. ; Haabeth, Ole A.W. ; Advani, Ranjana H. ; Gupta, Neel K. ; Negrin, Robert S. ; Rezvani, Andrew R. ; Czerwinski, Debra K. ; Alizadeh, Ash A. ; Brody, Joshua D. ; Sheehan, Kevin ; Miklos, David B. ; Maeda, Lauren S. ; Khodadoust, Michael S. ; Okada, Ami ; Reddy, Sunil A. ; Levy, Ronald ; Chu, Michael P.

Here, we report on the results of a phase I/II trial (NCT00490529) for patients with mantle cell lymphoma who, having achieved remission after immunochemotherapy, were vaccinated with irradiated, CpG-activated tumor cells. Subsequently, vaccine-primed lymphocytes were collected and reinfused after a standard autologous stem cell transplantation (ASCT). The primary endpoint was detection of minimal residual disease (MRD) within 1 yr after ASCT at the previously validated threshold of ≥1 malignant cell per 10,000 leukocyte equivalents. Of 45 evaluable patients, 40 (89%) were found to be MRD negative, and the MRD-positive patients experienced early subsequent relapse. The vaccination induced antitumor CD8 T cell immune responses in 40% of patients, and these were associated with favorable clinical outcomes. Patients with high tumor PD-L1 expression after in vitro exposure to CpG had inferior outcomes. Vaccination with CpG-stimulated autologous tumor cells followed by the adoptive transfer of vaccine-primed lymphocytes after ASCT is feasible and safe.

2020-06-17·Science Advances1区 · 综合性期刊

Engineering autologous tumor cell vaccine to locally mobilize antitumor immunity in tumor surgical bed

1区 · 综合性期刊

ArticleOA

作者: Ding, Yaping ; Zhang, Pengcheng ; Li, Yaping ; Fang, Lei ; Jiang, Yanyan ; Wang, Dangge ; Wang, Jue ; Zhao, Zitong

A feasible and transformable cancer vaccine was designed for personalized immunotherapy of postoperative tumors.

2018-12-01·Cancer Immunology, Immunotherapy2区 · 医学

A phase I/randomized phase II study of GM.CD40L vaccine in combination with CCL21 in patients with advanced lung adenocarcinoma

2区 · 医学

Article

作者: Chiappori, Alberto ; Haura, Eric B ; Tanvetyanon, Tawee ; Kelley, Linda ; Mediavilla-Varela, Melanie ; Kim, Jongphil ; Gray, Jhanelle E ; Boyle, Theresa A ; Williams, Charlie C ; Hopewell, Emily L ; Khalil, Farah ; Pinder-Schenck, Mary ; Antonia, Scott J ; Altiok, Soner ; Smilee, Renee ; Devane, Rebecca ; Creelan, Ben C ; Noyes, David

The GM.CD40L vaccine, which recruits and activates dendritic cells, migrates to lymph nodes, activating T cells and leading to systemic tumor cell killing. When combined with the CCL21 chemokine, which recruits T cells and enhances T-cell responses, additive effects have been demonstrated in non-small cell lung cancer mouse models. Here, we compared GM.CD40L versus GM.CD40L plus CCL21 (GM.CD40L.CCL21) in lung adenocarcinoma patients with ≥ 1 line of treatment. In this phase I/II randomized trial (NCT01433172), patients received intradermal vaccines every 14 days (3 doses) and then monthly (3 doses). A two-stage minimax design was used. During phase I, no dose-limiting toxicities were shown in three patients who received GM.CD40L.CCL21. During phase II, of evaluable patients, 5/33 patients (15.2%) randomized for GM.DCD40L (p = .023) and 3/32 patients (9.4%) randomized for GM.DCD40L.CCL21 (p = .20) showed 6-month progression-free survival. Median overall survival was 9.3 versus 9.5 months with GM.DCD40L versus GM.DCD40L.CCL21 (95% CI 0.70-2.25; p = .44). For GM.CD40L versus GM.CD40L.CCL21, the most common treatment-related adverse events (TRAEs) were grade 1/2 injection site reaction (51.4% versus 61.1%) and grade 1/2 fatigue (35.1% versus 47.2%). Grade 1 immune-mediated TRAEs were isolated to skin. No patients showed evidence of pseudo-progression or immune-related TRAEs of grade 1 or greater of pneumonitis, endocrinopathy, or colitis, and none discontinued treatment due to toxicity. Although we found no significant associations between vaccine immunogenicity and outcomes, in limited biopsies, one patient treated with GMCD40L.CCL21 displayed abundant tumor-infiltrating lymphocytes. This possible effectiveness warrants further investigation of GM.CD40L in combination approaches.

100 项与 CD40L-GVAX(University of South Florida) 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
肺腺癌	临床3期	美国	H. Lee Moffitt Cancer Center & Research Institute, Inc.	2012-03-26
肺腺癌	临床3期	美国	H. Lee Moffitt Cancer Center & Research Institute, Inc.	2012-03-26
皮肤黑色素瘤	临床3期	美国	H. Lee Moffitt Cancer Center & Research Institute, Inc.	2004-10-01
套细胞淋巴瘤	临床3期	美国	H. Lee Moffitt Cancer Center & Research Institute, Inc.	2004-07-01
非小细胞肺癌	临床2期	美国	Cell Genesys, Inc.	2002-05-01

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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


NCT01433172 (ASCO2016)	临床1/2期	晚期肺腺癌	35	GM.CD40L vaccine	(積衊顧夢顧鹽製鹽艱夢) = 繭繭蓋廠遞範範蓋簾襯製艱窪糧構糧顧築鏇壓 (壓願壓淵範製壓壓淵壓 ) 更多	不佳	2016-05-20
NCT01433172 (ASCO2016)	临床1/2期	晚期肺腺癌	35	GM.CD40L.CCL21 vaccine	(積衊顧夢顧鹽製鹽艱夢) = 觸鏇鏇餘簾鑰淵鹽窪夢製艱窪糧構糧顧築鏇壓 (壓願壓淵範製壓壓淵壓 ) 更多	不佳	2016-05-20
NCT00101101 (CTgov)	临床2期	套细胞淋巴瘤	43	cyclophosphamide+prednisone+Autologous Tumor Cell-Based Vaccine+doxorubicin+IL-2+Dexamethasone+Vincristine	鑰願糧鏇鑰憲夢鏇繭鹽(齋顧積衊遞淵夢簾窪顧) = 衊鬱簾衊蓋膚夢築觸構願壓鑰簾鑰範築膚鑰鬱 (餘觸憲鑰獵餘襯觸壓淵, 糧廠衊餘壓鏇觸築築簾 ~ 製獵簾淵選觸衊觸衊鏇) 更多	-	2013-09-04
NCT01433172 (ASCO2013)	临床1/2期	转移性非小细胞肺癌	73	GM.CD40L	(鹹製鬱範遞憲繭選廠蓋) = 壓鹹簾遞網鹽窪襯齋淵蓋鹹餘選顧襯製鏇積網 (構壓糧築鹹鹽廠鹽衊鏇 )	-	2013-05-20
NCT00101166 (CTgov)	临床2期	皮肤黑色素瘤	43	Bystander-Based Autologous Tumor Cell Vaccine	鏇醖窪繭簾壓齋觸壓觸(餘廠鹽襯簾糧鬱顧窪襯) = 醖構積憲鹹餘繭選積築憲遞觸憲獵簾夢鏇觸膚 (簾夢範鏇範範獵蓋鏇簾, 簾糧鹽繭衊遞夢鹽鏇艱 ~ 蓋鹽選壓遞壓廠築鹽觸) 更多	-	2012-11-16