(CD40L-GVAX) - 药物靶点：CD40 x CSF-2R_在研适应症：肺癌，黑色素瘤_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 vaccine、Bystander-based autologous tumour cell vaccine

+ [7]

靶点

CD40 x CSF-2R

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)

治疗领域

肿瘤呼吸系统疾病皮肤和肌肉骨骼疾病

在研适应症

肺癌黑色素瘤

非在研适应症

肺腺癌骨髓增生异常综合征

原研机构

University of South Florida

在研机构

University of South Florida

AbelZeta Pharma, Inc.

非在研机构

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

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

关联

4

项与 CD40L-GVAX 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.

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.

[+1]

NCT00101166 / Completed临床2期IIT

A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma

The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.

开始日期2004-10-01

申办/合作机构

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

[+3]

100 项与 CD40L-GVAX 相关的临床结果

登录后查看更多信息

100 项与 CD40L-GVAX 相关的转化医学

登录后查看更多信息

100 项与 CD40L-GVAX 相关的专利（医药）

登录后查看更多信息

78

项与 CD40L-GVAX 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. ; Khodadoust, Michael S. ; Maeda, Lauren 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 ; Boyle, Theresa A ; Williams, Charlie C ; Gray, Jhanelle E ; Mediavilla-Varela, Melanie ; Kim, Jongphil ; 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 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肺癌	临床2期	-	University of South Florida	-
肺癌	临床2期	中国	AbelZeta Pharma, Inc.	-
黑色素瘤	临床2期	中国	AbelZeta Pharma, Inc.	-
黑色素瘤	临床2期	-	University of South Florida	-
骨髓增生异常综合征	临床1期	中国	AbelZeta Pharma, Inc.	-
骨髓增生异常综合征	临床1期	-	University of South Florida	-
肺腺癌	临床前	-	H. Lee Moffitt Cancer Center & Research Institute, Inc.	2018-07-01

登录后查看更多信息

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


WCLC2013	N/A	转移性非小细胞肺癌	-	GM.CD40L	(鏇壓網遞齋鬱膚構憲觸) = 蓋範衊製壓鹽蓋窪壓憲餘鬱製醖選廠顧夢鑰構 (願網糧鹽衊憲憲衊壓願 ) 更多	-	2013-10-28
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	廠獵壓鏇壓夢膚築廠襯(夢醖鑰膚遞夢構餘窪鑰) = 齋網艱獵積築壓鹹顧選鑰範憲鹹鑰鬱襯廠蓋築 (餘範壓憲遞壓繭積蓋淵, 夢製艱醖構鏇醖製製積 ~ 壓築遞鹹糧構餘鏇壓齋) 更多	-	2013-09-04
NCT00101166 (CTgov)	临床2期	皮肤黑色素瘤	43	Bystander-Based Autologous Tumor Cell Vaccine	築窪鏇夢觸廠鏇襯範鏇(獵範窪築壓鑰範鏇構衊) = 鏇鑰齋醖襯鏇廠廠鏇窪築憲夢網觸網簾構築繭 (襯衊顧鑰製選鏇餘蓋鹽, 糧鏇鬱糧餘獵艱鏇鬱醖 ~ 窪壓願鹽膚鬱壓鏇構顧) 更多	-	2012-11-16