预约演示
更新于：2026-09-19
MUROMONAB-CD3
莫罗单抗-CD3
更新于：2026-09-19
概要
基本信息
在研机构- |
权益机构- |
最高研发阶段撤市 |
首次获批日期 美国 (1986-06-19), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 23109L
来源: *****
Sequence Code 143575H
来源: *****
关联
14
项与 莫罗单抗-CD3 相关的临床试验EUCTR2011-001071-40-AT
A Phase IIa Safety study of oral administration of anti-CD3 monoclonal antibody in non-responder genotype-I chronic Hepatitis C subjects, a single-blind, randomized, controlled multi-center study
NCT01287195
Oral Anti-CD3 for the Treatment of Active Ulcerative Colitis
NCT01205087
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody in Patients With the Metabolic Syndrome PHASE IIa A Single-blinded Placebo-controlled Clinical Trial
100 项与 莫罗单抗-CD3 相关的临床结果
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100 项与 莫罗单抗-CD3 相关的转化医学
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100 项与 莫罗单抗-CD3 相关的专利（医药）
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2,162
项与 莫罗单抗-CD3 相关的文献（医药）2026-03-31FASEB JOURNAL
Wnt Signaling Downregulation Mediates T Cell Apoptosis Following
OKT3
‐Induced T Cell Activation in Preclinical Models
Article
作者: Park, Duhyeon ; Choi, Chang Hoon ; Moon, Kyoung‐Sik ; Lee, Da‐Hee ; Jeong, Seo Yule ; Choi, Myeongjin ; Jo, Minseong ; Lim, Seung Yeon ; Park, Daeui
ABSTRACT:
OKT3 is a murine monoclonal antibody (mAb) directed against human CD3 expressed on T cells and is known to induce T cell activation followed by activation‐induced cell death. This study investigated the role of canonical Wnt signaling in OKT3‐mediated T cell activation and apoptosis using preclinical models. In primary human PBMCs, OKT3 treatment downregulated the expression of canonical Wnt signaling‐related genes, whereas the Wnt pathway activator CHIR99021 upregulated their expression and reversed the OKT3‐induced suppression. OKT3 stimulation upregulated T cell activation markers (CD69, CD25), particularly in CD8
+
T cells, and induced apoptosis as assessed by flow cytometry. Co‐treatment with CHIR99021 attenuated OKT3‐induced CD25 expression and late apoptosis, suggesting that Wnt signaling modulates T cell activation and cell death. In a humanized mouse model, OKT3 administration led to marked depletion of hCD3
+
, hCD4
+
, and hCD8
+
T cells in the peripheral blood. Transcriptomic profiling using RNA‐seq of liver‐infiltrating human immune cells revealed significant upregulation of genes involved in T cell activation, apoptosis, cytokine signaling, and oxidative stress, accompanied by widespread downregulation of Wnt signaling genes (CTNNB1, LRP6, DVL1, FZD family). Therefore, these findings suggest that OKT3 induces T cell responses characterized by activation and subsequent apoptosis, in association with Wnt signaling. This study provides mechanistic insight into OKT3‐mediated immunomodulation and supports preclinical evaluation of T cell‐targeting monoclonal antibodies.
2025-12-31mAbs
Monoclonal antibody formulations: a quantitative analysis of marketed products and patents
Article
作者: Wu, Chuan-Yu ; Lyu, Liyang ; Chen, Shiyun ; Ning, Baoming ; Li, Chihua ; Peng, Yixuan ; Hu, Yuanjia
Since the approval of OKT3® in 1986, monoclonal antibodies (mAbs) have become a cornerstone of modern therapeutics. However, their complex physicochemical properties pose challenges, particularly for high-concentration formulation and subcutaneous administration. Excipient selection is crucial for maintaining mAb stability and efficacy, yet existing studies often lack systematic, cross-source analyses. This study integrates data from marketed products and patents to investigate formulation trends and excipient preferences. Data were retrieved from the Drugs@FDA databases, CAS Formulations Database and Derwent Innovation as of December 31, 2024. Extracted information included target, indication, dosage form, route of administration, and formulation composition. The associations between formulation-related factors (e.g., antibody concentration, route of administration) and excipient selection were evaluated using proportion tests. A total of 6,119 patent records and 108 marketed mAb products (covering 388 patented and 141 marketed formulations) were analyzed. Proportion tests revealed significant associations between antibody concentration and the use of histidine (marketed p = 0.0017) and citric acid (marketed p = 0.0047). The route of administration also influenced excipient choice, notably for hyaluronidase (marketed p = 0.0167; patent p = 0.0056). In addition, lyophilized formulations accounted for a relatively small fraction of both marketed (14.18%) and patented (14.69%) products, with sucrose emerging as the predominant lyoprotectant. This study analyzed excipient usage in marketed and patent formulations by time, concentration, and administration route. High-concentration products more frequently included histidine, arginine, and hyaluronidase, while low-concentration ones used citric/phosphoric acid, trehalose, and NaCl. Intravenous formulations commonly used phosphate/citric buffers, while histidine, arginine, hyaluronidase, and methionine buffers were favored for subcutaneous administration. Lyophilized formulations consistently contained sucrose as the main excipient to mitigate freeze-drying stresses. Additionally, surfactants were essential across formulations to prevent surface-induced aggregation. Patent data could provide early indications of emerging formulation strategies, though further validation is needed to confirm their predictive value.
2025-12-01Journal for ImmunoTherapy of Cancer
Selective expansion of T-cell receptor engineered T cells with increased stem-like phenotypes using neoantigen stimulation
Article
作者: Vale, Nolan R ; Levy, Lior ; Khateb, Mamduh ; Farid, Shahram ; Marquardt, Charles ; Jo, Youngseo ; Yu, Zhiya ; Rosenberg, Steven A ; Kim, Sanghyun P ; Ray, Satyajit ; Halas, Hyunmi ; Klemen, Nicholas D ; Parkhust, Maria ; Magna, Melinda ; Goff, Stephanie L ; Levin, Noam
Background:
Adoptive transfer of T-cell receptor-engineered T cells (TCR-T cells) has shown promising efficacy in solid tumor treatment, but achieving clinical benefit typically requires infusion of tens of billions of cells. The commonly used rapid expansion protocol (REP), based on the CD3-agonistic OKT3 antibody and irradiated allogeneic feeder cells, exponentially expands tumor-infiltrating lymphocytes (TILs). However, the effect of REP on TCR-T cell frequency and phenotype remains unclear. This study aimed to evaluate the impact of REP on TCR-T cells and to assess the potential of a neoantigen-specific stimulation platform, NeoExpand, as a strategy to selectively expand TCR-T cells with favorable phenotypes.
Methods:
We compared the effects of REP and NeoExpand on the frequency, yield, and phenotype of TCR-T cells engineered against shared neoantigens. Various autologous antigen-presenting cell (APC) types, including dendritic cells and bulk peripheral blood mononuclear cells (PBMCs), were tested as stimulators in NeoExpand. Additionally, we combined NeoExpand with CD3 activation, with or without allogeneic feeders, to improve scalability. The role of exogenous interleukin (IL)-21 in shaping TCR-T cell phenotypes was also investigated.
Results:
REP impaired the frequency and phenotype of TCR-T cells, particularly CD4
+
and CD8
+
subsets matched to their engineered TCRs. In contrast, NeoExpand selectively increased TCR-T cell frequency and improved their phenotypes but did not consistently achieve higher total yields compared with REP. Among the tested autologous APCs, PBMCs effectively supported selective expansion. Further optimization using PBMCs as APCs revealed that combining NeoExpand with CD3 activation enabled exponential expansion without compromising selectivity. Inclusion of IL-21 during NeoExpand promoted a naïve/stem-like phenotype in CD8
+
TCR-T cells, with minimal effect on CD4
+
TCR-T cells.
Conclusions:
These findings demonstrate that NeoExpand enables selective expansion of TCR-T cells while preserving favorable phenotypes and scalability. The approach supports further clinical evaluation of NeoExpand as a strategy to generate high-quality TCR-T cell products for adoptive cell therapy.
144
项与 莫罗单抗-CD3 相关的新闻（医药）2026-09-13
·药聊聊
申请上市临床研究
100 项与 莫罗单抗-CD3 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 同种异体移植排斥反应 | 美国 | 1986-06-19 | |
| 肾移植排斥反应 | 美国 | 1986-06-19 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性丙型肝炎 | 临床2期 | 奥地利 | 2011-11-01 | |
| 慢性丙型肝炎 | 临床2期 | 波兰 | 2011-11-01 | |
| 肿瘤 | 临床1期 | 意大利 | - | - |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1/2期 | 6 | 積齋夢積鹹憲廠餘鑰憲 = 憲選願鬱範構廠鹹製選 膚淵膚膚餘選淵網築艱 (顧襯範鹽餘膚製鹹簾鑰, 鏇壓壓壓範鑰顧觸醖製 ~ 衊壓糧範艱艱襯齋積鹹) 更多 | - | 2017-06-14 | |||
临床2期 | 73 | CliniMACS+Fludarabine+Cyclophosphamide+Muromonab+Anti-thymocyte globulin (Rabbit)+G-CSF+mycophenolate mofetil+L-phenylalanine mustard+Rituxan™+Thioplex®+Alemtuzumab | 觸鏇糧鏇廠顧願壓壓觸 = 鹹鏇夢鹽築憲窪簾網製 顧顧積憲範窪蓋衊繭獵 (鹽襯範廠糧艱鹹願鑰製, 鹹蓋艱餘顧齋膚夢製蓋 ~ 壓繭遞範範醖鏇構齋選) 更多 | - | 2016-05-03 | ||
临床1期 | 6 | Anti-CD3 x Anti-HER2/neu Bispecific Antibody | 選鬱網顧夢壓願積膚願(積壓構壓淵鏇顧襯夢鬱) = 膚選獵積範膚願襯繭積 襯壓蓋鹽衊觸繭觸窪鹹 (鹹網選觸鏇範憲願醖鬱 ) | - | 2001-04-01 |
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