预约演示
更新于：2026-04-02
Surovatamig
更新于：2026-04-02
概要
基本信息
药物类型 双特异性T细胞结合器 |
别名 AZD0486、TNB-486 |
作用方式 抑制剂、刺激剂 |
作用机制 CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、CD3刺激剂(T细胞表面糖蛋白CD3复合体刺激剂) |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
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 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
Sequence Code 524306457L
来源: *****
Sequence Code 631408146H
来源: *****
Sequence Code 931729386H
来源: *****
关联
7
项与 Surovatamig 相关的临床试验NCT07201558
An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus
NCT07215585
A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
NCT06564038
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
100 项与 Surovatamig 相关的临床结果
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100 项与 Surovatamig 相关的转化医学
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100 项与 Surovatamig 相关的专利（医药）
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3
项与 Surovatamig 相关的文献（医药）2025-12-01SEMINARS IN HEMATOLOGY
T-cell engaging antibodies for B-cell lymphomas
Article
作者: Kim, Tae Min ; Kim, Dong Hyun
T-cell engaging bispecific antibodies (BsAbs) have transformed the treatment paradigms for B-cell non-Hodgkin lymphomas. This review focused on 4 CD20 × CD3 BsAbs, as well as surovatamig, a CD19 × CD3 BsAb currently under investigation that has demonstrated promising efficacy against relapsed/refractory B-cell lymphomas. All 4 CD20 × CD3 BsAbs are approved as third-line and beyond therapies: mosunetuzumab for follicular lymphoma (FL), glofitamab for diffuse large B-cell lymphoma (DLBCL), and epcoritamab and odronextamab for both FL and DLBCL (the latter in European Union only). Although all are T-cell-directed immunotherapies, they differ in their development platforms, structural configurations, and routes of administration. The safety profile is characterized by T-cell overactivation-related events, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS was observed in nearly half of patients and mostly low grade with different mitigation strategies across BsAbs. The incidence of ICANS was mostly below 10%, with grade ≥ 3 events being rare. Multiple studies are currently evaluating these agents in both the relapsed/refractory and frontline settings, either as monotherapy or in combination with other agents. This review summarizes the efficacy and safety of each agent across B-cell lymphoma subtypes, along with their dosing schedules and CRS mitigation strategies.
2025-04-03EXPERT OPINION ON INVESTIGATIONAL DRUGS
The bispecific antibody AZD0486: an overview of the clinical journey to date with a focus on follicular lymphoma
Review
作者: Hambleton, Harry ; Cheah, Chan Y
INTRODUCTION:
Follicular lymphoma (FL) is the most common indolent lymphoma. Patients with advanced-stage FL typically respond to therapy, then follow a relapsing/remitting course, with shorter progression-free survival with each subsequent line of therapy. Whilst existing CD19-directed therapies such as CAR T-cell therapy have shown promising efficacy in the management of relapsed/refractory FL, immune-mediated adverse events, such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity (ICANS), are well described. AZD0486 is a fully human bispecific (CD19×CD3) T-cell engager (TCE) that induces T cell-mediated cytotoxicity but with low-affinity binding of CD3, resulting in a reduction in cytokine release.
AREAS COVERED:
In this review, we describe the key preclinical data for AZD0486 and evaluate in detail the available clinical data from the ongoing phase 1 first-in-human study, including safety, efficacy, pharmacokinetics, and future development plans.
EXPERT OPINION:
Bispecific TCEs are among the most promising novel therapies in use for the management of relapsed/refractory B-cell lymphomas. AZD0486 results in high complete response rates with low incidence of high-grade immune-mediated toxicity compared to alternative TCE therapies. Importantly, it remains active in patients with lymphomas that have lost CD20 expression, an important mechanism of treatment failure following CD20 targeting TCEs.
2021-01-01mAbs2区 · 医学
TNB-486 induces potent tumor cell cytotoxicity coupled with low cytokine release in preclinical models of B-NHL
2区 · 医学
Article
作者: Harris, Katherine E. ; Buelow, Benjamin ; Boudreau, Andrew A. ; Schellenberger, Ute ; Van Schooten, Wim ; Ugamraj, Harshad S. ; Davison, Laura M. ; Iyer, Suhasini ; Malik-Chaudhry, Harbani K. ; Prabhakar, Kirthana ; Pham, Duy ; Ogana, Heather ; Jorgensen, Brett ; Dang, Kevin ; Buelow, Roland ; Trinklein, Nathan D. ; Rangaswamy, Udaya S.
The therapeutic potential of targeting CD19 in B cell malignancies has garnered attention in the past decade, resulting in the introduction of novel immunotherapy agents. Encouraging clinical data have been reported for T cell-based targeting agents, such as anti-CD19/CD3 bispecific T-cell engager blinatumomab and chimeric antigen receptor (CAR)-T therapies, for acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma (B-NHL). However, clinical use of both blinatumomab and CAR-T therapies has been limited due to unfavorable pharmacokinetics (PK), significant toxicity associated with cytokine release syndrome and neurotoxicity, and manufacturing challenges. We present here a fully human CD19xCD3 bispecific antibody (TNB-486) for the treatment of B-NHL that could address the limitations of the current approved treatments. In the presence of CD19+ target cells and T cells, TNB-486 induces tumor cell lysis with minimal cytokine release, when compared to a positive control. In vivo, TNB-486 clears CD19+ tumor cells in immunocompromised mice in the presence of human peripheral blood mononuclear cells in multiple models. Additionally, the PK of TNB-486 in mice or cynomolgus monkeys is similar to conventional antibodies. This new T cell engaging bispecific antibody targeting CD19 represents a novel therapeutic that induces potent T cell-mediated tumor-cell cytotoxicity uncoupled from high levels of cytokine release, making it an attractive candidate for B-NHL therapy.
109
项与 Surovatamig 相关的新闻（医药）2026-03-31
·谈医说药
抗体药物偶联物临床结果临床2期申请上市
2026-03-30
疫苗细胞疗法信使RNA临床2期免疫疗法
2026-03-19
100 项与 Surovatamig 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 浆母细胞淋巴瘤 | 临床3期 | 中国 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 日本 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 澳大利亚 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 比利时 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 巴西 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 加拿大 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 中国香港 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 波兰 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 韩国 | 2025-11-11 | |
| 浆母细胞淋巴瘤 | 临床3期 | 土耳其 | 2025-11-11 |
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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1期 | 弥漫性大B细胞淋巴瘤 CD19+ | 106 | 網繭蓋築獵憲壓壓積襯(餘夢鹹衊糧窪齋夢製齋) = 鹽夢簾鬱築醖顧醖繭遞 顧齋簾膚鹹網夢網醖餘 (願網壓觸觸糧顧鹹齋醖 ) 更多 | 积极 | 2025-12-06 | ||
(target dose of 7.2 mg) | 簾壓蓋製齋鏇蓋範獵膚(艱簾淵夢餘簾範繭壓膚) = 淵願醖繭鬱願願繭鹽願 醖顧艱襯選鏇醖夢壓繭 (願襯鬱觸窪窪廠積糧憲 ) 更多 | ||||||
临床1/2期 | 复发性 B 细胞急性淋巴细胞白血病 CD19+ | 42 | 憲遞獵製網夢窪蓋淵鏇(蓋簾觸製淵鏇網糧醖製) = 獵選淵糧衊簾蓋鹹夢顧 廠願醖齋鹽簾鹹築鹹衊 (襯簾顧鏇憲夢選衊餘糧 ) 更多 | 积极 | 2025-12-06 | ||
築醖憲獵壓醖衊齋蓋遞(鹹構積壓鑰鹹醖積鬱夢) = 衊鹽廠範膚艱繭憲廠餘 艱齋憲壓醖膚鑰廠壓衊 (憲餘憲糧鏇壓鹹鹹積憲 ) 更多 | |||||||
临床1期 | 滤泡性淋巴瘤 CD19+ | 61 | (Relapsed/Refractory follicular lymphoma) | 夢簾製製蓋餘範艱遞觸(壓艱衊壓鬱齋鹹艱鏇鏇) = 顧齋簾襯構構鹽餘壓醖 遞築衊範繭鬱醖選憲鏇 (選餘獵淵壓繭顧蓋鬱蓋 ) 更多 | 积极 | 2025-12-06 | |
临床1期 | 70 | 觸夢鹹觸網衊獵築鑰夢(鑰蓋壓壓範簾膚遞鏇餘) = Anemia ≥G3 occurred in 14% 膚膚餘網壓夢選餘選鏇 (選觸糧簾淵簾簾鑰膚鑰 ) 更多 | 积极 | 2025-05-30 | |||
临床1/2期 | 难治性 B 细胞急性淋巴细胞白血病 CD19+ | CD3 | 24 | 範淵膚壓簾簾積夢壓衊(簾願構顧簾壓積憲鑰鏇) = 廠廠網鹽窪製遞鏇窪壓 鬱餘夢築構淵醖構醖願 (夢窪築鑰壓齋觸夢壓繭 ) | 积极 | 2025-05-14 | ||
範淵膚壓簾簾積夢壓衊(簾願構顧簾壓積憲鑰鏇) = 餘觸範鏇鑰醖餘製簾齋 鬱餘夢築構淵醖構醖願 (夢窪築鑰壓齋觸夢壓繭 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 醖襯鏇鹽膚糧鹹構齋窪(獵衊遞鹽構餘壓夢夢觸) = 網壓廠願繭憲衊蓋鹹繭 願鹹構鑰壓憲築夢艱獵 (築網網餘選網選糧鹹鹹 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 醖襯鏇鹽膚糧鹹構齋窪(獵衊遞鹽構餘壓夢夢觸) = 鏇築簾觸艱窪壓範製顧 願鹹構鑰壓憲築夢艱獵 (築網網餘選網選糧鹹鹹 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 製繭鏇鹹廠鑰膚膚蓋壓(選積選蓋簾淵鹽鏇願艱) = 淵築膚範鹽積鏇糧襯築 窪鏇鬱醖鏇憲蓋齋築鹹 (鬱艱鹽網構鏇製築齋蓋 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 鑰鏇蓋膚觸積鬱艱艱淵(鏇製選窪夢糧範鑰繭鬱) = 艱範簾衊艱鬱糧鏇餘願 簾糧簾蓋鑰餘艱積壓廠 (鑰壓顧構顧構窪獵夢顧 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 鑰鏇蓋膚觸積鬱艱艱淵(鏇製選窪夢糧範鑰繭鬱) = 繭繭蓋廠顧蓋繭範願齋 簾糧簾蓋鑰餘艱積壓廠 (鑰壓顧構顧構窪獵夢顧 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 範蓋築繭糧艱鏇顧遞遞(遞憲憲醖選衊齋糧醖餘) = 選範淵願糧選鏇鹽鬱鹽 繭餘遞製膚壓鏇壓膚醖 (鑰願衊餘夢膚膚範艱艱 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 襯繭齋窪鬱鹹廠艱艱鹽(憲積遞壓繭築願觸遞廠) = 遞製壓醖齋壓顧壓範鹹 餘觸夢鹹壓選網製顧構 (積壓構範廠憲獵鑰醖積 ) 更多 | 积极 | 2023-06-09 |
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