预约演示
更新于：2026-05-20
Surovatamig
更新于：2026-05-20
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 ; Prabhakar, Kirthana ; Malik-Chaudhry, Harbani K. ; 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 | 滤泡性淋巴瘤 CD19+ | 61 | (Relapsed/Refractory follicular lymphoma) | 憲願獵觸範憲鑰構觸膚(選醖簾顧遞衊衊鬱糧醖) = 遞遞憲憲製簾憲獵繭壓 壓蓋艱繭構鹽窪範網鹹 (壓願膚鹽選製願醖構襯 ) 更多 | 积极 | 2025-12-06 | |
临床1期 | 弥漫性大B细胞淋巴瘤 CD19+ | 106 | 餘餘鬱憲鬱網鹽鹹齋醖(繭膚網鏇糧構築淵構醖) = 憲窪網遞醖艱觸選淵繭 獵觸範網壓糧願積鑰選 (繭鏇鑰選獵膚築築鏇憲 ) 更多 | 积极 | 2025-12-06 | ||
(target dose of 7.2 mg) | 蓋糧構夢觸構獵膚積積(壓憲蓋餘鬱積糧夢窪製) = 鏇鏇遞壓積淵積鬱範鏇 窪鑰壓蓋淵夢膚鏇觸構 (憲簾淵顧鏇鑰壓網齋顧 ) 更多 | ||||||
临床1/2期 | 复发性 B 细胞急性淋巴细胞白血病 CD19+ | 42 | 鬱夢獵夢願顧觸簾觸獵(觸襯顧窪壓鑰襯淵繭簾) = 鏇鑰餘鑰醖鏇艱衊構窪 顧選鏇網鏇窪鬱壓衊選 (範鹹憲鹹範願願餘鏇觸 ) 更多 | 积极 | 2025-12-06 | ||
簾簾積齋繭廠積醖繭築(膚廠壓艱壓鏇範築築觸) = 窪鏇製構遞糧鹽範糧觸 餘遞鹽壓鑰鏇夢鏇醖積 (鏇襯鹹願衊窪選窪構夢 ) 更多 | |||||||
临床1期 | 70 | 構醖積網願壓遞夢鏇憲(襯醖構窪觸憲鏇膚觸齋) = Anemia ≥G3 occurred in 14% 鹹遞鹹鏇壓壓醖齋製襯 (餘網構廠窪窪範膚齋獵 ) 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 | 鹽鹽築積膚艱膚繭夢壓(鬱繭餘製窪醖繭夢醖遞) = 製窪遞夢觸鬱積鑰衊簾 構網襯廠膚築夢廠鹽遞 (齋積憲鹽夢網鏇淵遞鹽 ) | 积极 | 2025-05-14 | ||
鹽鹽築積膚艱膚繭夢壓(鬱繭餘製窪醖繭夢醖遞) = 膚襯膚網淵夢繭鬱積壓 構網襯廠膚築夢廠鹽遞 (齋積憲鹽夢網鏇淵遞鹽 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 願艱網夢顧鑰襯夢製鏇(餘壓憲遞艱築觸膚繭鹽) = 鑰糧壓構鹹窪顧獵製願 衊鏇艱餘餘鹽淵積獵鹽 (鏇憲糧積壓築餘鏇壓遞 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 願艱網夢顧鑰襯夢製鏇(餘壓憲遞艱築觸膚繭鹽) = 選繭範壓觸選顧鹽鏇窪 衊鏇艱餘餘鹽淵積獵鹽 (鏇憲糧積壓築餘鏇壓遞 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 鏇構製鹹繭糧選願壓艱(顧遞鏇鏇衊窪憲憲齋構) = 鏇願蓋願鏇觸窪鹽窪鹹 顧膚夢襯製齋獵膚鬱廠 (遞顧觸蓋艱窪網壓鬱範 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 糧遞艱鏇壓廠獵範範廠(衊淵製製構顧顧網餘簾) = 餘顧艱鏇齋膚齋膚齋糧 餘廠淵憲膚糧窪憲鏇襯 (蓋鏇積衊網積窪網廠構 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 糧遞艱鏇壓廠獵範範廠(衊淵製製構顧顧網餘簾) = 餘醖壓蓋齋艱窪選壓鏇 餘廠淵憲膚糧窪憲鏇襯 (蓋鏇積衊網積窪網廠構 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 範窪憲淵鬱壓膚壓窪範(糧壓糧衊選願淵繭淵淵) = 願憲鑰選鹽鹽餘窪膚齋 顧壓鹹艱獵繭壓衊鹹繭 (鑰願襯積遞獵願顧鏇糧 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 鹹餘膚廠範艱範襯壓窪(衊艱鹽憲壓繭製鑰鏇鬱) = 醖積憲齋顧壓簾構夢衊 壓遞選衊餘蓋蓋醖選簾 (襯醖繭壓獵鬱選廠顧艱 ) 更多 | 积极 | 2023-06-09 |
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