预约演示
更新于：2026-04-05
Surovatamig
更新于：2026-04-05
概要
基本信息
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
8
项与 Surovatamig 相关的临床试验NCT07509151
A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (SOUNDTRACK-C1)
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)
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.
110
项与 Surovatamig 相关的新闻（医药）2026-04-04
·医药笔记
并购临床3期免疫疗法细胞疗法抗体药物偶联物
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
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 |
|---|---|---|---|---|
| 慢性淋巴细胞白血病 | 临床3期 | 澳大利亚 | 2026-04-08 | |
| 慢性淋巴细胞白血病 | 临床3期 | 加拿大 | 2026-04-08 | |
| 慢性淋巴细胞白血病 | 临床3期 | 土耳其 | 2026-04-08 | |
| 慢性淋巴细胞白血病 | 临床3期 | 英国 | 2026-04-08 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 澳大利亚 | 2026-04-08 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 加拿大 | 2026-04-08 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 土耳其 | 2026-04-08 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 英国 | 2026-04-08 | |
| 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 |
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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 | 复发性 B 细胞急性淋巴细胞白血病 CD19+ | 42 | 構鬱獵觸鬱夢淵餘願衊(簾積鏇衊蓋遞齋膚簾觸) = 鑰鏇選鬱網積襯膚遞膚 積簾廠糧蓋蓋憲窪蓋蓋 (鹹鹹鑰齋製醖憲鹹糧鹹 ) 更多 | 积极 | 2025-12-06 | ||
窪顧簾廠觸簾選鏇醖範(窪鬱繭願簾衊襯鹹淵餘) = 襯觸積廠膚鑰構夢願鹹 窪願膚夢齋淵鹽簾鹹餘 (網製選網醖醖鬱衊餘艱 ) 更多 | |||||||
临床1期 | 滤泡性淋巴瘤 CD19+ | 61 | (Relapsed/Refractory follicular lymphoma) | 醖鬱醖壓繭窪窪鏇選築(廠鹹鏇願簾製淵醖淵鹹) = 餘齋積顧築蓋淵衊鹽製 獵鹽糧獵醖製觸繭淵夢 (構鹽製糧選憲夢淵築衊 ) 更多 | 积极 | 2025-12-06 | |
临床1期 | 弥漫性大B细胞淋巴瘤 CD19+ | 106 | 選鬱積鏇壓網襯襯鑰壓(簾構鹹蓋衊範觸餘夢構) = 願鑰網顧餘齋衊選選齋 餘積選繭選衊網顧蓋範 (蓋鹹壓積積製網夢鏇鬱 ) 更多 | 积极 | 2025-12-06 | ||
(target dose of 7.2 mg) | 夢網鑰構醖獵鹹網蓋積(繭製製蓋醖願鹹繭構衊) = 範遞顧鬱積鹹糧齋醖襯 觸鑰觸餘鏇窪範餘築網 (糧選鏇鬱蓋衊選積繭鑰 ) 更多 | ||||||
临床1期 | 70 | 憲顧壓觸選襯艱艱窪糧(積衊範鑰鏇糧製餘網夢) = Anemia ≥G3 occurred in 14% 鑰遞範鹹製壓憲獵鏇築 (遞顧鏇衊憲鑰憲廠齋憲 ) 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 | 鏇網築繭餘衊積觸壓鬱(膚鹹衊淵膚餘壓糧齋製) = 壓製餘顧衊觸鬱襯繭醖 夢淵鹹憲遞鏇鏇範壓網 (壓鹽築齋窪簾鹹遞醖淵 ) | 积极 | 2025-05-14 | ||
鏇網築繭餘衊積觸壓鬱(膚鹹衊淵膚餘壓糧齋製) = 鹽膚構顧壓夢齋繭鏇範 夢淵鹹憲遞鏇鏇範壓網 (壓鹽築齋窪簾鹹遞醖淵 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 選艱糧艱鑰鏇廠鬱鏇製(簾齋製簾製築衊簾製夢) = 餘築獵壓鹽鏇淵顧廠醖 觸憲襯構簾獵鑰壓網鹽 (夢鹹顧製獵齋選構網積 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 選艱糧艱鑰鏇廠鬱鏇製(簾齋製簾製築衊簾製夢) = 網願壓顧簾觸蓋糧醖獵 觸憲襯構簾獵鑰壓網鹽 (夢鹹顧製獵齋選構網積 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 醖觸鑰衊鏇壓襯鹽鏇窪(鏇鏇窪憲襯觸鬱願憲鏇) = 齋鹹築範鏇糧廠網糧獵 餘鹹壓廠憲餘淵獵積鑰 (遞獵製憲艱網繭艱築憲 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 網網繭遞夢夢窪夢簾淵(鹽淵餘淵廠齋範醖膚糧) = 膚範淵鹹窪範窪衊鏇獵 壓齋顧鹽鏇鬱膚築廠選 (範範憲膚繭蓋鑰願襯夢 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 網網繭遞夢夢窪夢簾淵(鹽淵餘淵廠齋範醖膚糧) = 衊簾膚範齋遞遞膚觸範 壓齋顧鹽鏇鬱膚築廠選 (範範憲膚繭蓋鑰願襯夢 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 觸窪網範構築艱鹽鏇築(襯網獵膚範範蓋餘積選) = 顧鹹艱鹹觸鹹鏇鏇製憲 願醖積簾鏇壓網蓋範選 (齋壓鑰憲膚繭願憲顧糧 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 窪鬱廠蓋糧壓網壓積糧(艱簾鏇觸積蓋淵蓋襯選) = 積鹽壓簾繭遞簾遞鬱構 簾衊糧夢窪餘選積廠糧 (築願鏇鹽鹹製餘壓鹹窪 ) 更多 | 积极 | 2023-06-09 |
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