A Phase II, Open-Label Study of the CDX-1307 Vaccine Regimen as Neoadjuvant and Adjuvant Therapy in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer Expressing hCG-β

The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine regimen when it is given before and after bladder cancer surgery. The study will also provide information about the safety of the vaccine regimen when given in combination with chemotherapy, and how it affects the immune systems.

开始日期2010-04-01

申办/合作机构

Celldex Therapeutics, Inc.

NCT00648102 / Completed临床1期

A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, a Mannose Receptor-Targeted hCG-β Vaccine, in Patients With Incurable Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder and Ovarian Cancer

This research study is for individuals who have advanced breast, colon, pancreatic, ovarian or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer. The study includes administration of additional treatments, in combination, thought to enhance the immune response effect. This study specifically administers the vaccine systemically to explore whether dendritic cell targeted vaccines can generate more robust effects via intravenous injection. (CDX 1307-02)

开始日期2006-01-01

申办/合作机构

Celldex Therapeutics, Inc.

NCT00709462 / Completed临床1期

A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, a Mannose Receptor-Targeted hCG-β Vaccine, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX-1307-01)

开始日期2004-03-01

申办/合作机构

Celldex Therapeutics, Inc.

100 项与 CDX-1307 相关的临床结果

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100 项与 CDX-1307 相关的转化医学

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100 项与 CDX-1307 相关的专利（医药）

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项与 CDX-1307 相关的文献（医药）

2011-07-15·Clinical Cancer Research1区 · 医学

Phase I Study Utilizing a Novel Antigen-Presenting Cell–Targeted Vaccine with Toll-like Receptor Stimulation to Induce Immunity to Self-antigens in Cancer Patients

1区 · 医学

Article

作者: Powderly, John ; Green, Jennifer ; Blackwell, Kimberly ; He, Li-Zhen ; Butler, Stephen A. ; Chapman, Robert ; Osada, Takuya ; Lyerly, H. Kim ; Riggs, Renee ; Morse, Michael A. ; Hobeika, Amy ; Zhao, Biwei ; Keler, Tibor ; Davis, Thomas ; Ramakrishna, Venky ; Vitale, Laura ; Clay, Timothy

AbstractPurpose: The use of tumor-derived proteins as cancer vaccines is complicated by tolerance to these self-antigens. Tolerance may be broken by immunization with activated, autologous, ex vivo generated and antigen-loaded, antigen-presenting cells (APC); however, targeting tumor antigen directly to APC in vivo would be a less complicated strategy. We wished to test whether targeted delivery of an otherwise poorly immunogenic, soluble antigen to APC through their mannose receptors (MR) would induce clinically relevant immunity.Experimental Design: Two phase I studies were conducted with CDX-1307, a vaccine composed of human chorionic gonadotropin beta-chain (hCG-β) fused to an MR-specific monoclonal antibody, administered either locally (intradermally) or systemically (intravenously) in patients with advanced epithelial malignancies. An initial dose escalation of single-agent CDX-1307 was followed by additional cohorts of CDX-1307 combined with granulocyte-macrophage colony-stimulating factor (GM-CSF) and the Toll-like receptor (TLR) 3 agonist polyinosinic-polycytidylic acid (poly-ICLC) and TLR7/8 agonist resiquimod to activate the APC.Results: CDX-1307 induced consistent humoral and T-cell responses to hCG-β when coadministered with TLR agonists. Greater immune responses and clinical benefit, including the longest duration of stable disease, were observed with immunization combined with local TLR agonists. Immune responses were induced equally efficiently in patients with elevated and nonelevated levels of serum hCG-β. Antibodies within the serum of vaccinated participants had tumor suppressive function in vitro. Toxicity consisted chiefly of mild injection site reactions.Conclusions: APC targeting and activation induce adaptive immunity against poorly immunogenic self-antigens which has implications for enhancing the efficacy of cancer immunotherapy. Clin Cancer Res; 17(14); 4844–53. ©2011 AACR.

2011-06-01·Expert Review of Vaccines2区 · 医学

CDX-1307: a novel vaccine under study as treatment for muscle-invasive bladder cancer

2区 · 医学

Review

作者: Robert J Laliberte ; Brant A Inman ; Deborah A Bradley ; Tibor Keler ; Jennifer A Green ; Michael A Morse ; Thomas A Davis

Cancer vaccines have demonstrated clinical benefit, however greater efficacy could be achieved by enhancing their immunogenicity. Owing to cancer vaccines depending on uptake and cross-presentation of tumor antigens by antigen-presenting cells (APCs), we hypothesized that greater immunogenicity would accompany strategies that direct antigen to APC-expressed mannose receptors, initiating a pathway increasing class I and II presentation to T cells. CDX-1307 consists of a human monoclonal antibody targeting the mannose receptor, fused to the human chorionic gonadotropin-β chain (hCG-β), a tumor antigen frequently expressed by epithelial cancers including bladder cancer. In Phase I studies of cancer patients, CDX-1307 was well tolerated and induced significant hCG-β-specific cellular and humoral immune responses when co-administered with GM-CSF and the Toll-like receptor agonists resiquimod and poly-ICLC. An ongoing Phase II trial evaluates CDX-1307 in patients with newly diagnosed, resectable, hCG-β-expressing bladder cancer, where low tumor burden and early intervention may provide greater potential for benefit.

100 项与 CDX-1307 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
肌层浸润性膀胱癌	临床2期	美国	Celldex Therapeutics, Inc.	2010-04-01
膀胱癌	临床2期	-	Bristol Myers Squibb Co.	-
乳腺癌	临床2期	-	Bristol Myers Squibb Co.	-
乳腺癌	临床2期	-	Bristol Myers Squibb Co.	-
结直肠癌	临床2期	-	Bristol Myers Squibb Co.	-
结直肠癌	临床2期	-	Bristol Myers Squibb Co.	-
卵巢癌	临床2期	-	Bristol Myers Squibb Co.	-
卵巢癌	临床2期	-	Bristol Myers Squibb Co.	-
胰腺癌	临床2期	-	Bristol Myers Squibb Co.	-
胰腺癌	临床2期	-	Bristol Myers Squibb Co.	-

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临床结果

适应症

分期

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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


ASCO2009	临床1期	肿瘤	-	CDX-1307	(鏇憲構艱襯範壓蓋淵廠) = 夢齋鹹醖壓願製築窪製顧選願選齋廠淵顧簾糧 (獵糧鬱膚鹽鹹憲窪積窪 )	-	2009-05-20