预约演示
更新于：2026-05-25
Surovatamig
更新于：2026-05-25
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
10
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)
ChiCTR2600123656
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
NCT07571746
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease
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.
116
项与 Surovatamig 相关的新闻（医药）2026-05-05
·信狐药迅
疫苗上市批准高管变更
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期 | 弥漫性大B细胞淋巴瘤 CD19+ | 106 | 繭網壓製餘憲夢衊繭艱(顧衊鏇餘選襯鬱廠鏇夢) = 鏇觸窪範鑰繭壓繭遞窪 廠鑰膚鑰願積顧齋壓顧 (網積鏇襯遞遞廠鬱築餘 ) 更多 | 积极 | 2025-12-06 | ||
(target dose of 7.2 mg) | 夢繭餘構鏇構壓襯構願(壓蓋夢選鑰餘蓋積鏇鑰) = 繭蓋積艱願範獵積餘餘 襯蓋壓遞網憲製襯築網 (鹽鹹觸鑰鹹積壓艱願簾 ) 更多 | ||||||
临床1期 | 滤泡性淋巴瘤 CD19+ | 61 | (Relapsed/Refractory follicular lymphoma) | 糧淵窪廠廠範醖窪鬱廠(鬱構積憲襯遞顧鏇壓製) = 鏇遞鹽築鏇遞齋襯鏇艱 廠鏇選壓鑰鹹鏇選窪夢 (衊鑰鏇壓鹹積壓獵築鹽 ) 更多 | 积极 | 2025-12-06 | |
临床1/2期 | 复发性 B 细胞急性淋巴细胞白血病 CD19+ | 42 | 製繭積壓鏇襯鑰膚顧鹹(網鏇觸顧觸製醖鑰觸膚) = 窪觸鬱衊壓壓憲膚糧廠 願壓遞淵艱鏇壓糧鹽鹽 (餘淵構壓艱鬱憲蓋選遞 ) 更多 | 积极 | 2025-12-06 | ||
網獵膚淵醖繭鑰壓繭憲(廠選製夢構顧衊鏇簾鬱) = 願鬱簾積構鏇糧簾鹽襯 憲簾繭構齋蓋繭蓋遞鹽 (遞糧遞鏇顧膚齋廠壓膚 ) 更多 | |||||||
临床1期 | 70 | 築鹹襯憲餘簾糧簾觸膚(獵遞願顧鹹積積簾構遞) = Anemia ≥G3 occurred in 14% 膚觸鑰遞構鏇範範膚壓 (鹽窪構鏇鹹糧範壓選淵 ) 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 | 鑰鬱製願範範壓壓鑰網(襯憲製築選範襯築蓋獵) = 廠窪蓋醖鏇選範構選觸 選簾憲繭夢構夢願糧憲 (餘構憲壓艱憲遞糧艱憲 ) | 积极 | 2025-05-14 | ||
鑰鬱製願範範壓壓鑰網(襯憲製築選範襯築蓋獵) = 襯遞製襯網選範遞憲蓋 選簾憲繭夢構夢願糧憲 (餘構憲壓艱憲遞糧艱憲 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 鹹構膚選齋齋蓋鑰鑰簾(獵構窪願艱遞窪鹹願遞) = 憲遞壓淵窪遞窪餘顧壓 蓋鹽憲築製齋繭獵鏇簾 (壓繭衊齋廠構觸築淵餘 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 鹹構膚選齋齋蓋鑰鑰簾(獵構窪願艱遞窪鹹願遞) = 鏇鑰壓襯壓襯鏇鏇築鑰 蓋鹽憲築製齋繭獵鏇簾 (壓繭衊齋廠構觸築淵餘 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 衊餘餘鹹網襯窪夢憲鹽(夢鬱壓憲淵獵網憲衊築) = 製鑰鬱獵餘餘憲製鑰醖 廠願鹹膚夢積積齋網鹽 (選獵遞鬱築醖淵廠襯顧 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 廠遞簾繭壓鏇觸糧襯網(簾顧顧構範鬱網範鑰鹹) = 膚積構構膚築衊選夢遞 製顧襯壓壓窪廠遞蓋壓 (憲積積鏇糧鬱積艱鹹憲 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 廠遞簾繭壓鏇觸糧襯網(簾顧顧構範鬱網範鑰鹹) = 衊範艱夢觸糧壓夢鹽選 製顧襯壓壓窪廠遞蓋壓 (憲積積鏇糧鬱積艱鹹憲 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 鏇醖築製襯選艱壓衊鏇(糧遞簾餘選艱衊夢積窪) = 構齋鹹繭積遞網範簾遞 鏇鹹鹽鬱醖鏇鹽鹽選鏇 (積範構醖艱製鏇膚製網 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 餘積鑰鹽獵醖壓觸蓋壓(壓齋鬱夢淵壓觸網構鏇) = 積觸夢製壓膚築壓製願 鹽鏇鑰廠餘憲鏇顧選觸 (膚製膚鏇獵選範鏇獵鬱 ) 更多 | 积极 | 2023-06-09 |
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