MART-1 antigen(NCI)(MART-1 antigen(NCI)) - 药物靶点：melan-A_专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名-

靶点

melan-A

作用机制

melan-A抑制剂(T细胞识别黑素瘤抗原抑制剂)

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

IV期恶性黑色素瘤复发性黑色素瘤皮肤黑色素瘤+ [2]

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-

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关联

23

项与 MART-1 antigen(NCI) 相关的临床试验

NCT02320305 / Completed早期临床1期IIT

Peptide Vaccine With Glucopyranosyl Lipid A - Stable Oil-in-Water Emulsion (GLA-SE) for Patients With Resected Melanoma: A Pilot Study

This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.

开始日期2015-01-27

申办/合作机构

Mayo Clinic

[+1]

NCT01748747 / Completed早期临床1期IIT

Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately

开始日期2012-10-01

申办/合作机构

Mayo Clinic

[+1]

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

100 项与 MART-1 antigen(NCI) 相关的临床结果

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100 项与 MART-1 antigen(NCI) 相关的转化医学

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100 项与 MART-1 antigen(NCI) 相关的专利（医药）

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12

项与 MART-1 antigen(NCI) 相关的文献（医药）

2021-05-01·Journal for ImmunoTherapy of Cancer2区 · 医学

Randomized phase II trial of lymphodepletion plus adoptive cell transfer of tumor-infiltrating lymphocytes, with or without dendritic cell vaccination, in patients with metastatic melanoma

2区 · 医学

ArticleOA

作者: Bernatchez, Chantale ; Najjar, Amer M ; Amaria, Rodabe N ; Haymaker, Cara L ; Faria, Silvana C ; Tawbi, Hussein A ; Davies, Michael A ; Saberian, Chantal ; Patel, Sapna ; Bassett, Roland L ; Yee, Cassian ; McQuade, Jennifer L ; Glitza, Isabella C ; Wong, Michael K ; Alvarez, Enrique ; Radvanyi, Laszlo G ; Diab, Adi ; Parshottam, Sapna ; Forget, Marie-Andrée ; Shpall, Elizabeth J ; Hwu, Patrick ; Prieto, Victor ; Lizée, Gregory

BackgroundThe adoptive transfer of tumor-infiltrating lymphocytes (TIL) has demonstrated robust efficacy in metastatic melanoma patients. Tumor antigen–loaded dendritic cells (DCs) are believed to optimally activate antigen-specific T lymphocytes. We hypothesized that the combined transfer of TIL, containing a melanoma antigen recognized by T cells 1 (MART-1) specific population, with MART-1-pulsed DC will result in enhanced proliferation and prolonged survival of transferred MART-1 specific T cells in vivo ultimately leading to improved clinical responses.DesignWe tested the combination of TIL and DC in a phase II clinical trial of patients with advanced stage IV melanoma. HLA-A0201 patients whose early TIL cultures demonstrated reactivity to MART-1 peptide were randomly assigned to receive TIL alone or TIL +DC pulsed with MART-1 peptide. The primary endpoint was to evaluate the persistence of MART-1 TIL in the two arms. Secondary endpoints were to evaluate clinical response and survival.ResultsTen patients were given TIL alone while eight patients received TIL+DC vaccine. Infused MART-1 reactive CD8+ TIL were tracked in the blood over time by flow cytometry and results show good persistence in both arms, with no difference in the persistence of MART-1 between the two arms. The objective response rate was 30% (3/10) in the TIL arm and 50% (4/8) in the TIL+DC arm. All treatments were well tolerated.ConclusionsThe combination of TIL +DC showed no difference in the persistence of MART-1 TIL compared with TIL therapy alone. Although more patients showed a clinical response to TIL+DC therapy, this study was not powered to resolve differences between groups.Trial registration numberNCT00338377.

2014-12-01·Journal of Translational Medicine2区 · 医学

MART-1 peptide vaccination plus IMP321 (LAG-3Ig fusion protein) in patients receiving autologous PBMCs after lymphodepletion: results of a Phase I trial

2区 · 医学

ArticleOA

作者: Daniel E Speiser ; Alexandre Harari ; Pedro Romero ; Serge Leyvraz ; Verena Voelter ; Frédéric Triebel ; Athina Stravodimou ; Olivier Michielin ; Emanuela Romano ; Hélène Bichat ; Julien Laurent

BACKGROUNDImmunotherapy offers a promising novel approach for the treatment of cancer and both adoptive T-cell transfer and immune modulation lead to regression of advanced melanoma. However, the potential synergy between these two strategies remains unclear.METHODSWe investigated in 12 patients with advanced stage IV melanoma the effect of multiple MART-1 analog peptide vaccinations with (n = 6) or without (n = 6) IMP321 (LAG-3Ig fusion protein) as an adjuvant in combination with lymphodepleting chemotherapy and adoptive transfer of autologous PBMCs at day (D) 0 (Trial registration No: NCT00324623). All patients were selected on the basis of ex vivo detectable MART-1-specific CD8 T-cell responses and immunized at D0, 8, 15, 22, 28, 52, and 74 post-reinfusion.RESULTSAfter immunization, a significant expansion of MART-1-specific CD8 T cells was measured in 83% (n = 5/6) and 17% (n = 1/6) of patients from the IMP321 and control groups, respectively (P < 0.02). Compared to the control group, the mean fold increase of MART-1-specific CD8 T cells in the IMP321 group was respectively >2-, >4- and >6-fold higher at D15, D30 and D60 (P < 0.02). Long-lasting MART-1-specific CD8 T-cell responses were significantly associated with IMP321 (P < 0.02). At the peak of the response, MART-1-specific CD8 T cells contained higher proportions of effector (CCR7⁻ CD45RA⁺/⁻) cells in the IMP321 group (P < 0.02) and showed no sign of exhaustion (i.e. were mostly PD1⁻CD160⁻TIM3⁻LAG3⁻2B4⁺/⁻). Moreover, IMP321 was associated with a significantly reduced expansion of regulatory T cells (P < 0.04); consistently, we observed a negative correlation between the relative expansion of MART-1-specific CD8 T cells and of regulatory T cells. Finally, although there were no confirmed responses as per RECIST criteria, a transient, 30-day partial response was observed in a patient from the IMP321 group.CONCLUSIONSVaccination with IMP321 as an adjuvant in combination with lymphodepleting chemotherapy and adoptive transfer of autologous PBMCs induced more robust and durable cellular antitumor immune responses, supporting further development of IMP321 as an adjuvant for future immunotherapeutic strategies.

2013-09-01·International Journal of Pharmaceutics2区 · 医学

Long term stability of lyophilized plasmid DNA pDERMATT

2区 · 医学

Article

作者: Bastiaan Nuijen ; Jos H. Beijnen ; Iris van der Heijden

In this short note we report on the shelf-life stability of pDERMATT (plasmid DNA encoding recombinant MART-1 and tetanus toxin fragment-c) 2mg lyophilized powder for reconstitution for intradermal administration, used in an in-house, investigator-initiated clinical phase I study. pDERMATT was stored at 25°C/60% relative humidity (6 months), 2-8°C (24 months), and -20°C (66 months) in the dark and analyzed at several timepoints during the conduct of the clinical study for appearance, identity, purity (plasmid topology), content and residual water content. pDERMATT appeared stable at all storage conditions for the periods tested which, although patient inclusion in the study was significantly delayed, ensured the clinical supply needs. This study shows that lyophilization is an useful tool to preserve the quality of the pDNA and can prevent the need for costly and time-consuming additional manufacture of drug product in case of study delays, not uncommon at the early stage of drug development. To our knowledge, this is the first study reporting shelf life stability of a pDNA formulation for more than 5 years.

100 项与 MART-1 antigen(NCI) 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
IV期恶性黑色素瘤	申请上市	美国	National Cancer Institute	2004-06-01
复发性黑色素瘤	临床2期	美国	National Cancer Institute	2011-02-01
皮肤黑色素瘤	临床2期	美国	National Cancer Institute	2011-02-01
转移性黑色素瘤	临床2期	美国	National Cancer Institute	2011-02-01
葡萄膜黑色素瘤	临床2期	美国	National Cancer Institute	2004-06-01

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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


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))	(鹹淵選廠窪廠網鏇願醖) = 製淵鬱醖鏇觸選憲蓋餘鬱醖衊餘簾膚鬱夢糧糧 (網壓鏇膚觸鏇觸憲遞醖, 壓艱鬱廠齋獵鹹衊選鏇 ~ 築範衊鹹鑰範遞網憲窪) 更多	-	2016-10-24
				Recombinant Interleukin-12+NA17.A2 Peptide Vaccine+Recombinant MAGE-3.1 Antigen (Arm II (Vaccine Therapy, IL-12))	(鹹淵選廠窪廠網鏇願醖) = 製廠窪鬱鏇簾醖壓淵鏇鬱醖衊餘簾膚鬱夢糧糧 (網壓鏇膚觸鏇觸憲遞醖, 範蓋製蓋築壓繭鹹糧艱 ~ 襯獵衊鬱夢糧艱鏇獵壓) 更多