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更新于：2026-07-10
Mezagitamab
迈泽妥单抗
更新于：2026-07-10
概要
基本信息
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、儿科研究计划 (欧盟) |
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结构/序列
Sequence Code 210789L
来源: *****
Sequence Code 1191632864H
来源: *****
关联
12
项与 迈泽妥单抗 相关的临床试验NCT07613359
A Double-Blind, Placebo-Controlled, Multicenter, Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Mezagitamab (TAK-079) in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
NCT06948318
A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia
NCT06963827
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy
100 项与 迈泽妥单抗 相关的临床结果
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100 项与 迈泽妥单抗 相关的转化医学
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100 项与 迈泽妥单抗 相关的专利（医药）
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56
项与 迈泽妥单抗 相关的文献（医药）2026-04-09NEW ENGLAND JOURNAL OF MEDICINE
A Phase 2 Randomized Trial of Mezagitamab in Primary Immune Thrombocytopenia
Article
作者: Syrigou, Antonia ; Miura, Katsuhiro ; Nguyen, Van Anh ; Radinoff, Atanas ; Skelton, Emily ; Yang, Renchi ; Patriarca, Andrea ; Sapunarova, Katya ; Wang, Scarlett ; Patwari, Parth ; Pulanić, Dražen ; Yee, Donald L. ; Kuter, David J.
BACKGROUND:
Immune thrombocytopenia (ITP) is a disorder of increased platelet destruction and reduced platelet production and is associated with an increased bleeding risk and a compromised quality of life. Available therapies are ineffective in at least 20% of cases. Mezagitamab is an anti-CD38 antibody that targets plasma cells, plasmablasts, and natural killer cells.
METHODS:
We conducted this multicenter, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of mezagitamab at a dose of 100 mg, 300 mg, or 600 mg, as compared with placebo, administered subcutaneously once weekly for 8 weeks in adults with persistent or chronic ITP (mean platelet count on ≥2 measurements, <30,000 per microliter). The primary end point was adverse events. A key secondary efficacy end point was a platelet response (defined by a platelet count of ≥50,000 per microliter and ≥20,000 per microliter above the baseline value) on at least two visits at any time through week 16.
RESULTS:
In the combined mezagitamab groups (28 participants), the mean age was 50 years (range, 24 to 88) and the mean number of previous ITP therapies was 4 (range, 1 to 9); in the combined placebo groups (13 participants), the mean age was 39 years (range, 20 to 65) and the mean number of previous ITP therapies was 4 (range, 1 to 13). The mean baseline platelet count was 19,100 and 17,300 per microliter, respectively. Adverse events were reported in 19 of 28 participants (68%) in the combined mezagitamab groups and in 9 of 13 participants (69%) in the combined placebo groups; adverse events of grade 3 or higher in 5 of 28 participants (18%) and in 3 of 13 participants (23%), respectively; and serious adverse events in 4 of 28 participants (14%) and in 1 of 13 participants (8%). Through week 16, a platelet response was observed in 10 of 11 participants (91%) in the mezagitamab 600-mg group and in 3 of 13 participants (23%) in the combined placebo groups.
CONCLUSIONS:
Treatment with mezagitamab led to increased platelet counts, with a safety profile that appeared to be similar to that of placebo among participants with persistent or chronic ITP. (Funded by Takeda Development Center Americas; ClinicalTrials.gov number, NCT04278924.).
2026-04-01Current Opinion in Organ Transplantation
Managing the highly sensitized kidney transplant patient
Review
作者: Jackson, Kyle R. ; Parsons, Ronald F.
Purpose of review:
Highly sensitized kidney transplant candidates, particularly those with calculated panel reactive antibody (CPRA) ≥99.9%, face significant immunologic barriers to transplantation. This review highlights recent clinical strategies that have improved transplant access and outcomes in this population, with a focus on allocation policy, kidney-paired donation, and desensitization.
Recent findings:
Updates from national allocation systems and kidney-paired donation programs have demonstrated substantial gains in transplant access for many highly sensitized candidates. However, those with CPRA at least 99.9% remain difficult to match. Novel desensitization approaches, such as imlifidase, proteasome inhibitors, anti-CD38 mAbs, and early-phase CAR T-cell therapies have shown promise in selected patients. Increasingly, immunologic phenotyping or gene expression profiling may help tailor desensitization strategies to individual recipients.
Summary:
Most highly sensitized candidates now achieve transplant through allocation policy or paired donation. For those with CPRA at least 99.9%, desensitization will likely remain an important tool to facilitate transplantation. Emerging therapies and immunologic profiling may help individualize treatment and expand transplant access for this challenging group.
2026-01-06CLINICAL AND EXPERIMENTAL IMMUNOLOGY
Evolving understandings for the roles of CD38 protein in autoimmunity and autoimmune disease
Review
作者: Ares, Irma ; Zhang, Jieying ; Maximiliano, Jorge-Enrique ; Lopez-Torres, Bernardo ; Wang, Ping ; Ye, Xiaochun ; Anadón, Arturo ; Wang, Xu ; Martínez-Larrañaga, María-Rosa ; Song, Mengping ; Martínez, Marta ; Martínez, María-Aránzazu
Abstract:
Autoimmune diseases are chronic idiopathic disorders characterized by inflammatory responses. Cluster of differentiation 38 (CD38), a surface molecule with enzymatic and signalling capabilities, contributes to the regulation of NAD+ metabolism and mediates various intracellular pathways. Recent research has revealed the influence of the CD38 protein in the pathogenesis of autoimmune diseases. During inflammation, CD38 is involved in regulating biological processes such as cell recruitment, cell activation, cytokine and chemokine release, antigen presentation, and phagocytosis. Dysfunctional CD38 induces autoimmune diseases. CD38 is expressed at low levels in various haematopoietic systems and tissues but exhibits elevated expression in multiple myeloma and plasma cells. CD38-targeted monoclonal antibodies with favourable therapeutic effects have been discovered, such as isatuximab, daratumumab, and mezagitamab. Although CD38-targeted antibodies were originally developed to eliminate malignant immune cells and inhibit their strong activation, these monoclonal antibodies can also inhibit autoantibodies production in autoimmune diseases. CD38 protein is a promising biomarker of autoimmune disease diagnosis and a potential therapeutic target for the treatment of autoimmune diseases. In this review article, we will focus on the latest findings on the involvement of CD38 in autoimmunity and autoimmune disease and assess the value of research and therapeutic application of CD38 in disease control.
100 项与 迈泽妥单抗 相关的药物交易
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外链
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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 |
|---|---|---|---|---|
| 免疫球蛋白a肾病 | 临床3期 | 美国 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 中国 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 日本 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 阿根廷 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 澳大利亚 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 奥地利 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 加拿大 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 哥伦比亚 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 捷克 | 2025-07-15 | |
| 免疫球蛋白a肾病 | 临床3期 | 法国 | 2025-07-15 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 171 | Mezagitamab 600 mg | 膚願範選鬱鬱構繭觸膚(觸範鹹淵醖繭襯鹽膚鑰) = similar between mezagitamab and placebo (50% vs 45%) 膚鏇構構選範構顧衊鏇 (鑰壓選鬱襯糧製遞遞網 ) 更多 | 积极 | 2025-12-06 | ||
临床1期 | 17 | 獵鹹選繭窪積憲憲範膚(簾鹽鹽膚遞襯鬱觸餘餘) = 獵憲積製觸鬱蓋網網淵 壓遞顧網窪構鹽繭網糧 (選鬱壓選鑰顧襯願簾鹹 ) 更多 | 积极 | 2025-11-07 | |||
临床2期 | 41 | Placebo (Part A & B: Double Blind Period: Placebo) | 襯蓋膚鬱餘壓壓網鹹艱 = 憲鹹襯積壓簾獵鬱餘艱 夢範餘糧築積蓋構獵淵 (網憲鹽鹽範憲膚蓋構積, 淵膚淵廠蓋廠衊鬱糧簾 ~ 觸蓋夢餘壓憲網鑰蓋糧) 更多 | - | 2025-06-15 | ||
(Part A: Double Blind Period: TAK-079 100 mg) | 襯蓋膚鬱餘壓壓網鹹艱 = 鏇遞鑰壓遞憲鬱鹹鹽網 夢範餘糧築積蓋構獵淵 (網憲鹽鹽範憲膚蓋構積, 鹹衊鹹積淵餘膚製簾齋 ~ 網糧餘鹽衊憲夢獵壓選) 更多 | ||||||
临床1期 | 17 | Mezagitamab 600 mg + Angiotensin-converting enzyme inhibitor and/or angiotensin receptor blocker (IgA nephropathy) | 廠願膚廠範繭觸獵選繭(繭糧壓廠廠廠艱鹽鹽蓋) = 醖遞廠糧積選築糧獵蓋 構製蓋衊顧鬱衊積獵選 (憲糧艱製壓憲積醖艱鑰 ) 更多 | 积极 | 2025-06-04 | ||
临床1期 | 复发性多发性骨髓瘤 CD38 | - | 鹽範繭製衊繭憲壓範廠(觸鹽憲築鹹艱構膚遞簾) = Three patients discontinued treatment due to TEAEs 鹽積夢淵糧衊積醖鏇遞 (夢願網選選範鑰簾構遞 ) 更多 | 积极 | 2024-12-01 | ||
临床1期 | 17 | 簾簾構襯膚鏇餘繭淵築(鑰網淵窪製顧製艱艱構) = None 鹹廠齋膚餘衊淵淵糧艱 (簾願壓廠窪選壓餘鬱獵 ) 更多 | 积极 | 2024-10-25 | |||
临床2期 | - | 獵網鑰鹽艱顧顧鹽鹽齋(積網齋築鹽網願艱網鏇) = 遞構窪鏇衊襯鹽鹽膚鹹 鬱鏇餘選製積觸衊糧製 (醖觸糧構鬱艱醖衊蓋選 ) 更多 | 积极 | 2024-06-22 | |||
Placebo | 獵網鑰鹽艱顧顧鹽鹽齋(積網齋築鹽網願艱網鏇) = 願築範鬱積壓醖廠憲製 鬱鏇餘選製積觸衊糧製 (醖觸糧構鬱艱醖衊蓋選 ) 更多 | ||||||
临床1期 | 23 | TAK-079 Placebo (Pooled Placebo) | 製憲製鏇餘襯艱夢鬱積 = 齋壓願鑰鹽願獵壓觸鏇 顧衊獵鹽鑰鹽構蓋獵範 (鏇構壓製膚齋網襯壓壓, 淵蓋積襯鹽鹽膚鑰膚襯 ~ 廠襯齋齋鹹糧獵遞襯獵) 更多 | - | 2024-03-29 | ||
(TAK-079 90 mg) | 製憲製鏇餘襯艱夢鬱積 = 膚範糧衊壓壓夢膚鬱糧 顧衊獵鹽鑰鹽構蓋獵範 (鏇構壓製膚齋網襯壓壓, 鹹糧衊鬱鹹夢醖衊選顧 ~ 獵窪築襯膚獵衊網簾淵) 更多 | ||||||
临床2期 | - | 觸鬱壓淵積鬱製鏇構糧(網鬱願淵膚顧艱膚築廠) = Mezagitamab has been generally safe and well tolerated across all three cohorts. 襯願鏇繭夢製網窪鬱選 (獵選廠蓋膚選選範蓋夢 ) 更多 | 积极 | 2024-03-13 | |||
Placebo | |||||||
临床2期 | 36 | TAK-079 Placebo (TAK-079 Placebo-matching) | 構夢遞廠獵衊簾淵選襯 = 蓋夢簾觸襯製構窪襯網 餘糧鑰網繭顧繭網壓壓 (餘齋繭築鑰遞積繭鹽醖, 築夢淵餘壓憲構獵選艱 ~ 顧積夢蓋鹽窪糧顧簾網) 更多 | - | 2023-06-02 | ||
(TAK-079 300 mg) | 構夢遞廠獵衊簾淵選襯 = 鏇築積鑰齋衊顧觸築餘 餘糧鑰網繭顧繭網壓壓 (餘齋繭築鑰遞積繭鹽醖, 築製衊鏇願觸蓋壓鏇糧 ~ 選淵蓋蓋鏇觸膚廠衊鬱) 更多 |
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