A Phase 1 Study of Allogenic Off-the-Shelf Multi-Tumor-Associated Antigen-Specific T Cell Products (MT-401-OTS) Administered to Patients with Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndromes (RAPID)

This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or

开始日期2025-01-15

申办/合作机构

Marker Therapeutics, Inc.

NCT02546102

/ Suspended临床3期

A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy

ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.

开始日期2024-12-01

申办/合作机构

Precision Life Sciences Group

[+1]

NCT06372574

/ Withdrawn临床1期

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7617991 in HLA-A*02-Positive Patients With Locally Advanced and/or Metastatic MAGE-A4-Positive Solid Tumors

This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.

开始日期2024-09-30

申办/合作机构

Genentech, Inc.

100 项与 MAGE 相关的临床结果

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100 项与 MAGE 相关的转化医学

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0 项与 MAGE 相关的专利（医药）

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2,845

项与 MAGE 相关的文献（医药）

2025-06-01·Theriogenology

Knockdown of Mageb16 disrupts cell proliferation and lineage specification during mouse preimplantation development

Article

作者: Liu, Yong ; Bai, Ruisong ; Liu, Qing ; Li, Jian ; Zhang, Xiaoyu ; Wang, Hongcheng ; Bi, Yuheng ; Zhang, Shangrong ; Wu, Xiaoqing ; Ming, Xin ; Ding, Qing

Melanoma antigen family member B16 (Mageb16) is crucial for maintaining the pluripotency and differentiation of embryonic stem cells. However, the expression pattern and biological role of Mageb16 during preimplantation development remain unclear. In this study, we showed that Mageb16 mRNA expression was dynamic throughout preimplantation development, with the highest level occurring at the morula stage. The abundance of Mageb16 mRNA was effectively reduced via small interfering RNA (siRNA) microinjection. Mageb16 knockdown significantly reduced the blastocyst formation rate, outgrowth formation rate, and total number of cells per embryo. Importantly, the reduction in MAGEB16 blocked cell cycle progression at the G2/M phase and disrupted lineage segregation but did not induce DNA damage in preimplantation mouse embryos. Intriguingly, Mageb16 knockdown increased the level of histone H3 lysine 27 acetylation (H3K27ac) but attenuated transcriptional activity. Together, our results reveal a crucial role for Mageb16 in mouse preimplantation development, likely by controlling cell proliferation and lineage specification.

2025-05-01·International Journal of Biological Macromolecules

AprMH1 subtilisin from Bacillus zhangzhouensis MH1: Molecular cloning, characterization, and homology modeling

Article

作者: Ghorbel, Sofiane ; Elhamdi, Marwa ; Siegert, Petra ; Hmidet, Noomen ; Falkenberg, Fabian ; Bongaerts, Johannes ; Miled, Nabil

The growing demand for robust proteases in industrial applications, particularly those based on the widely used subtilisin family, necessitates the development of novel and improved enzymes. This study reports exploration and characterization of a subtilisin, AprMH1, isolated from a recently identified Bacillus zhangzhouensis MH1 (NCBI Acct. No. MZ569437). The isolated aprMH1 gene, consisting of 1146 bp and encoding a 381 amino acid protein, was successfully cloned and overexpressed in Bacillus subtilis DB104. The recombinant AprMH1 protease, belonging to the S8 subtilase family and sharing 99.27 % similarity with keratinase Ker1 (ANQ68333.1) of B. pumilus CCUG 66887, displayed remarkable biochemical properties that offer significant industrial potential. It was produced in a one-liter fermenter, yielding 400,000 U after 48 h, and purified to homogeneity by ion-exchange chromatography with a 3.4-fold purification. AprMH1, a monomer of 27.8 kDa, exhibited optimum activity at pH 10 and 55 °C. It remained stable between pH 7-11 and retained 64 % of activity at 50 °C for 1 h. It also remained stable with non-ionic surfactants and its stability with SDS was enhanced by propylene glycol. Structural insights were gained through 3D modeling and comparative analysis with subtilisin Carlsberg (P00780.2), Apr1 (P07518.1), and Savinase (P29600.1). AprMH1 was found to belong to a distinct alkaline subgroup within the true subtilisin subfamily, exhibiting superior activity and stability at higher temperatures, making it a promising candidate for applications in harsh industrial environments. These novel properties highlight the potential of AprMH1 for future industrial processes, especially in the detergent sector.

2025-04-22·JCI Insight

Investigation of a mouse model of Prader-Willi Syndrome with combined disruption of Necdin and Magel2

Article

作者: Sicardi, Alicia ; Klucznik, Jessica ; Buron, Julie ; Becquet, Denis ; Omnes, Felix ; Menuet, Clément ; Alifrangis, Marie-Sophie ; Schaller, Fabienne ; Prevot, Vincent ; Santos, Catarina ; Bouret, Sebastien G ; François-Bellan, Anne-Marie ; Muscatelli, Françoise ; Caron, Emilie ; Barelle, Pierre-Yves ; Watrin, Françoise

Prader-Willi syndrome (PWS) is a multigenic disorder caused by the loss of 7 contiguous paternally expressed genes. Mouse models with inactivation of all PWS genes are lethal. KO mouse models for each candidate gene have been generated, but they lack the functional interactions between PWS genes. Here, we revealed an interplay between Necdin and Magel2 PWS genes and generated a mouse model (named Del Ndn-Magel2 mice) with a deletion including both genes. A subset of Del Ndn-Magel2 mice showed neonatal lethality. Behaviorally, surviving mutant mice exhibited sensory delays during infancy and alterations in social exploration at adulthood. Del Ndn-Magel2 mice had a lower body weight before weaning, persisting after weaning in males only, with reduced fat mass and improved glucose tolerance as well as altered puberty. Adult mutant mice displayed increased ventilation and a persistent increase in apneas following a hypercapnic challenge. Transcriptomics analyses revealed a dysregulation of key circadian genes and alterations of genes associated with axonal function similar to patients with PWS. At neuroanatomical levels, Del Ndn-Magel2 mice had an impaired maturation of oxytocin neurons and a disrupted development of melanocortin circuits. Together, these data indicate that the Del Ndn-Magel2 mouse is a pertinent and genetically relevant model of PWS.

131

项与 MAGE 相关的新闻（医药）

2025-04-30

·药时空

DCR达80%！BioNTech公布全球首个mRNA肺癌疫苗临床数据

近日，BioNTech 在2025年AACR大会上首次展示了mRNA疫苗BNT116联合cemiplimab（西米普利单抗，PD1）用于无法接受铂类化疗作为一线治疗的虚弱患者的初期临床研究数据。这项研究名为LuCa-MERIT-1，是一项开放标签、多组别的I期临床试验，致力于考察BNT116单药及其联合用药的疗效与安全性。在此次会上公布的数据集中在BNT116联合西米普利单抗的效果，特别针对不适合进行一线化疗且TPS ≥1%的患者。截至 2024年12月1日，共有20名患者参与了BNT116联合西米普利单抗的治疗方案。结果显示，所有患者都经历了一些与BNT116治疗相关的不良事件，其中13名（65%）的不良事件与西米普利单抗有关，而有3名（15%）患者出现了≥G3级的不良事件，这些事件与BNT116的使用有关，涉及症状包括心动过速、缺氧和高血压。另有2名（10%）患者的≥G3级不良事件仅与BNT116有关。严重不良事件在7名患者（35%）中出现，其中3名（15%）仅与BNT116有关，另外3名仅与西米普利单抗有关。此外，未发现致使患者死亡的不良事件。在疗效方面，数据显示，在接受治疗的 20位患者中，有9名（45%）实现了部分缓解（PR），另外有7名（35%）患者的疾病状态保持稳定。在部分缓解的9名患者中，有2名的PD-L1TPS小于50%。经过确认的客观缓解率为45%，而疾病控制率则达到了80%，同时，中位无进展生存期为9.9个月。ctDNA分析显示，患者在治疗的第3周便已有显著的分子应答反应。BNT116联合西米普利单抗治疗表现出在虚弱的晚期非小细胞肺癌患者中良好的抗肿瘤活性，并能持续引导免疫应答，且安全性可控。BNT116 是由 BioNTech 研制的一种通过静脉注射的未经修饰的 RNA-脂质体治疗性癌症疫苗。它由六种 mRNA 组成，包括CLDN6 、KK-LC-1、MAGE-A3、MAGE-A4、MAGE-C1 和 PRAME ，每种 mRNA 均在非小细胞肺癌中编码一种常见的肿瘤相关抗原（TAA）。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

临床结果AACR会议疫苗信使RNA

2025-04-30

·求实药社

全球首个mRNA肺癌疫苗！BioNTech公布临床数据：DCR达80%

来源：RNAScript近日，BioNTech 在2025年AACR大会上首次展示了mRNA疫苗BNT116联合cemiplimab（西米普利单抗，PD1）用于无法接受铂类化疗作为一线治疗的虚弱患者的初期临床研究数据。这项研究名为LuCa-MERIT-1，是一项开放标签、多组别的I期临床试验，致力于考察BNT116单药及其联合用药的疗效与安全性。在此次会上公布的数据集中在BNT116联合西米普利单抗的效果，特别针对不适合进行一线化疗且TPS ≥1%的患者。截至 2024年12月1日，共有20名患者参与了BNT116联合西米普利单抗的治疗方案。结果显示，所有患者都经历了一些与BNT116治疗相关的不良事件，其中13名（65%）的不良事件与西米普利单抗有关，而有3名（15%）患者出现了≥G3级的不良事件，这些事件与BNT116的使用有关，涉及症状包括心动过速、缺氧和高血压。另有2名（10%）患者的≥G3级不良事件仅与BNT116有关。严重不良事件在7名患者（35%）中出现，其中3名（15%）仅与BNT116有关，另外3名仅与西米普利单抗有关。此外，未发现致使患者死亡的不良事件。在疗效方面，数据显示，在接受治疗的 20位患者中，有9名（45%）实现了部分缓解（PR），另外有7名（35%）患者的疾病状态保持稳定。在部分缓解的9名患者中，有2名的PD-L1TPS小于50%。经过确认的客观缓解率为45%，而疾病控制率则达到了80%，同时，中位无进展生存期为9.9个月。ctDNA分析显示，患者在治疗的第3周便已有显著的分子应答反应。BNT116联合西米普利单抗治疗表现出在虚弱的晚期非小细胞肺癌患者中良好的抗肿瘤活性，并能持续引导免疫应答，且安全性可控。BNT116 是由 BioNTech 研制的一种通过静脉注射的未经修饰的 RNA-脂质体治疗性癌症疫苗。它由六种 mRNA 组成，包括CLDN6 、KK-LC-1、MAGE-A3、MAGE-A4、MAGE-C1 和 PRAME ，每种 mRNA 均在非小细胞肺癌中编码一种常见的肿瘤相关抗原（TAA）。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们I-RNA 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

AACR会议疫苗信使RNA临床结果

2025-04-27

·Insight数据库

DCR 为 80% ! 全球首个 mRNA 肺癌疫苗一线临床数据公布 | AACR 2025

近日，BioNTech 在 2025 年 AACR 大会上公布了 mRNA 疫苗 BNT116 联合 cemiplimab（西米普利单抗，PD1）治疗铂类化疗（PBC）不适合作为一线疗法的虚弱患者的 I 期 LuCa-MERIT-1 研究初步数据（NCT05142189）。来源：AACR 官网LuCa-MERIT-1 是一项开放标签、多队列的 I 期临床试验，旨在评估 BNT116 单药或联合用药的疗效和安全性。此次公布的是 BNT116 联合西米普利单抗用于虚弱患者（不适合接受一线化疗，且 TPS ≥1%）的临床结果。截至 2024 年 12 月 1 日，20 名患者接受了 BNT116 联合西米普利单抗治疗。结果显示，所有患者均出现了 BNT116 治疗相关不良事件（TRAE），其中 13 名（65%）患者不良事件的发生与西米普利单抗有关，3名（15%）患者出现的 ≥G3 TRAE 与 BNT116 有关，包括室上性心动过速、缺氧和高血压。2名（10%）患者出现的 ≥G3 TRAE 与BNT116 有关。7 名患者 (35%) 出现了严重 TRAE，3 名 (15%) 仅与 BNT116 有关，3 名患者 (15%) 仅与西米普利单抗有关，没有出现致命的 TRAE。疗效方面，20 名患者中有 9 名 (45%) 实现部分缓解 (PR)，7 名 (35%) 达到疾病稳定。在这 9 名 PR 患者中，2 名的 PD-L1 TPS <50%。确认的客观缓解率为 45%，疾病控制率为 80%，中位无进展生存期为 9.9 个月。ctDNA 分析显示，早在治疗第 3 周，患者就已表现出强烈的分子学应答。BNT116 联合西米普利单抗在虚弱的晚期非小细胞肺癌患者中表现出良好的抗肿瘤活性、持续的免疫应答诱导和可控的安全性。BNT116 是由 BioNTech 开发的一款静脉注射、未经修饰的 RNA-脂质体治疗性癌症疫苗，由六种 mRNA（CLDN6、KK-LC-1、MAGE-A3、MAGE-A4、MAGE-C1 和 PRAME）组成，每种 mRNA 都编码一种在非小细胞肺癌中经常表达的肿瘤相关抗原（TAA）。封面来源：企业logo/站酷海洛免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙PR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn

AACR会议疫苗临床结果信使RNA临床1期