Recombinant MAGE-3.1 antigen(NCI)(Recombinant MAGE-3.1 antigen(NCI))

概要

基本信息

药物类型

通用抗原疫苗、治疗性疫苗

别名-

靶点

MAGEA1

作用机制

MAGEA1抑制剂(黑色素瘤抗原-1抑制剂)

治疗领域

肿瘤眼部疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症-

非在研适应症

结节外侵犯复发性黑色素瘤皮肤黑色素瘤+ [3]

原研机构

National Cancer Institute

在研机构-

非在研机构

National Cancer Institute

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

4

项与 Recombinant MAGE-3.1 antigen(NCI) 相关的临床试验

NCT01307618 / Terminated临床2期IIT

A Randomized Phase II Study of Multipeptide Vaccination With or Without IL-12, Then Combined With Regulatory T Cell Depletion Using Daclizumab in Patients With Metastatic Melanoma

This randomized phase II trial is studying how well giving vaccine therapy together with or without recombinant interleukin-12 followed by daclizumab works in treating patients with melanoma that has spread to other places in the body. Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells. Recombinant interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may decrease the number of regulatory T cells (T cells that suppress the activation of the immmune system) and may lead to a better immune response against melanoma. It is not yet known whether vaccine therapy is more effective with interleukin-12 and daclizumab in treating melanoma.

开始日期2011-02-01

申办/合作机构

National Cancer Institute

NCT00085189 / Completed临床2期IIT

A PHASE II TRIAL OF A VACCINE COMBINING MULTIPLE CLASS I PEPTIDES WITH MONTANIDE ISA 51 OR ISA 51 VG AND CpG ADJUVANT 7909 FOR PATIENTS WITH RESECTED STAGES IIC/III AND IV MELANOMA

This pilot phase II trial studies how well giving vaccine therapy works in treating patients with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells

开始日期2004-05-01

申办/合作机构

University of Southern California

[+1]

NCT00003792 / Completed临床1期IIT

Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial

RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

开始日期1999-04-01

申办/合作机构

Baylor Health Care System (Texas)

[+1]

100 项与 Recombinant MAGE-3.1 antigen(NCI) 相关的临床结果

登录后查看更多信息

100 项与 Recombinant MAGE-3.1 antigen(NCI) 相关的转化医学

登录后查看更多信息

100 项与 Recombinant MAGE-3.1 antigen(NCI) 相关的专利（医药）

登录后查看更多信息

5

项与 Recombinant MAGE-3.1 antigen(NCI) 相关的文献（医药）

2006-01-01·The Korean Journal of Parasitology4区 · 医学

Usefulness of the recombinant liver stage antigen-3 for an early serodiagnosis of Plasmodium falciparum infection

4区 · 医学

Article

作者: Chung, Kyung-Suk ; Moon, Sung-Ung ; Na, Byoung-Kuk ; Kong, Yoon ; Chung, Gyung-Tae ; Lee, Hyeong-Woo ; Ryu, Hye-Sun ; Kim, Tong-Soo ; Lin, Khin ; Kim, Yeon-Joo ; Cho, Shin-Hyeong

In order to develop tools for an early serodiagnosis of Plasmodium falciparum infection, we evaluated the usefulness of P. falciparum liver stage antigen-3 (LSA-3) as a serodiagnostic antigen. A portion of LSA-3 gene was cloned, and its recombinant protein (rLSA-3) was expressed in Escherichia coli and purified by column chromatography. The purified rLSA-3 and 120 test blood/serum samples collected from inhabitants in malaria-endemic areas of Mandalay, Myanmar were used for this study. In microscopic examinations of blood samples, P. falciparum positive rate was 39.1% (47/120) in thin smear trials, and 33.3% (40/120) in thick smear trials. Although the positive rate associated with the rLSA-3 (30.8%) was lower than that of the blood stage antigens (70.8%), rLSA-3 based enzyme-linked immunosorbent assay could detect 12 seropositive cases (10.0%), in which blood stage antigens were not detected. These results indicate that the LSA-3 is a useful antigen for an early serodiagnosis of P. falciparum infection.

2005-11-20·International Journal of Cancer1区 · 医学

Phase 1/2 study of subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with detectable metastatic melanoma

1区 · 医学

Article

作者: Wim H.J. Kruit ; Marie-Françoise Avril ; Brigitte Dréno ; Poulam Patel ; Vincent G. Brichard ; Heidi H. van Ojik ; Sophie Piperno ; Pierre van der Bruggen ; Thierry Dorval ; Thierry Boon ; Marie Marchand ; Francis Brasseur ; Marguerite Stas ; Alexander M.M. Eggermont ; Bernard Lethé ; Amir Khammari ; Yi Zhang ; Gerd Ritter ; Nicolas van Baren ; Danièle Godelaine ; Bernard Escudier

The purpose of this phase 1/2 study was to evaluate toxicity, tumor evolution and immunologic response following administration of a fixed dose of a recombinant MAGE-3 protein by subcutaneous and intradermal routes in the absence of immunologic adjuvant. Thirty-two patients with detectable metastatic melanoma expressing gene MAGE-3 were included and 30 received at least one injection with a fixed dose of a ProtD-MAGE-3 fusion protein. The immunization schedule included 6 intradermal and subcutaneous injections at 3-week intervals. Afterward, patients without major tumor progression who required other treatments received additional vaccinations at increasing time intervals. The vaccine was generally well tolerated. Among the 26 patients who received at least 4 vaccinations, we observed 1 partial response and 4 mixed responses. For these 5 responding patients, time to progression varied from 3.5 to 51+ months. An anti-MAGE-3 CD4 T-lymphocyte response was detected in 1 out of the 5 responding patients. The majority of patients had no anti-MAGE-3 antibody response. The clinical and immunologic responses generated by the vaccine are rather limited. Nevertheless, given the potential antitumor efficacy and the very mild toxicity of vaccinations, further studies combining MAGE proteins and/or peptides with potent immunologic adjuvants are warranted, not only in metastatic melanoma, but also in the adjuvant setting.

2004-01-01·Journal of Immunotherapy4区 · 医学

Immunologic Analysis of a Phase I/II Study of Vaccination with MAGE-3 Protein Combined with the AS02B Adjuvant in Patients with MAGE-3-Positive Tumors

4区 · 医学

Article

作者: Marchand, Marie ; Keilholz, Ulrich ; Delire, Marcel ; Dantinne, Christine ; Lamers, Cor H. J. ; Permanne, Philippe ; Gheysen, Dirk ; Gueguen, Maryse ; Amrani, Noreddine ; Bruck, Claudine ; Britten, Cedrik M. ; Stoter, Gerrit ; Vantomme, Valerie

In a phase I/II study, patients with solid metastatic MAGE-3-positive tumors, mainly melanoma, were vaccinated with recombinant MAGE-3 protein combined with the immunologic adjuvant AS02B comprised of MPL and QS21 in an oil-in-water emulsion. The recombinant MAGE-3 protein was made up of a partial sequence of the protein D (ProtD) antigen of Haemophilus influenzae fused to the MAGE-3 sequence. The vaccine was given intramuscularly at 3-week intervals. Patients whose tumors stabilized or regressed after 4 vaccinations received 2 additional vaccinations at 6-week intervals. MAGE-3 and ProtD antibody and cellular immune responses were monitored after vaccination. Ninety-six percent (23/24) of the patients vaccinated with MAGE-3 protein in AS02B adjuvant elicited a significant anti-MAGE-3 IgG antibody response after 4 vaccinations, and all developed anti-ProtD IgG antibodies. For the detection of T-cell activity, total peripheral blood mononuclear cells were restimulated in vitro with MAGE-3- or ProtD-loaded autologous mature dendritic cells. In 30% of the evaluable patients vaccinated with the adjuvanted recombinant protein, IFNgamma production was increased in response to MAGE-3, and 2 patients (14% of evaluable patients) had a concomitant increase in IL-5 production. In 37% and 43% of the patients, respectively, IFNgamma or IL-5 production was increased in response to ProtD. It is concluded that vaccination of advanced cancer patients with MAGE-3 self-antigen in AS02B adjuvant is able to elicit MAGE-3-specific antibody and a T-cell response.

100 项与 Recombinant MAGE-3.1 antigen(NCI) 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
皮肤黑色素瘤	临床2期	美国	National Cancer Institute	2011-02-01
结节外侵犯	临床2期	美国	National Cancer Institute	2004-05-01
复发性黑色素瘤	临床2期	美国	National Cancer Institute	2004-05-01
转移性黑色素瘤	临床2期	美国	National Cancer Institute	2004-05-01
黏膜黑色素瘤	临床2期	美国	National Cancer Institute	2004-05-01
葡萄膜黑色素瘤	临床2期	美国	National Cancer Institute	2004-05-01

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


NCT01307618 (CTgov)	临床2期	皮肤黑色素瘤 \| 复发性黑色素瘤 \| 转移性黑色素瘤	10	Laboratory Biomarker Analysis+NA17.A2 Peptide Vaccine+Recombinant MAGE-3.1 Antigen+MART-1 Antigen (Arm I (Vaccine Therapy))	(壓遞夢憲願壓獵範廠構) = 願顧壓蓋齋憲膚築憲製襯遞鹹憲網製齋鹽壓艱 (窪窪膚鏇繭鏇鹹廠窪積, 淵窪鬱窪衊鏇鏇襯壓顧 ~ 廠築壓襯獵憲衊簾構獵) 更多	-	2016-10-24
				Recombinant Interleukin-12+NA17.A2 Peptide Vaccine+Recombinant MAGE-3.1 Antigen (Arm II (Vaccine Therapy, IL-12))	(壓遞夢憲願壓獵範廠構) = 鬱鏇遞選獵製構築網衊襯遞鹹憲網製齋鹽壓艱 (窪窪膚鏇繭鏇鹹廠窪積, 壓顧範遞鬱鏇構憲構範 ~ 鹹鏇壓艱鏇遞壓艱築製) 更多