预约演示
更新于：2026-06-09
Surovatamig
更新于：2026-06-09
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.
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 | 2026-05-05 | |
| 慢性淋巴细胞白血病 | 临床3期 | 加拿大 | 2026-05-05 | |
| 慢性淋巴细胞白血病 | 临床3期 | 土耳其 | 2026-05-05 | |
| 慢性淋巴细胞白血病 | 临床3期 | 英国 | 2026-05-05 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 澳大利亚 | 2026-05-05 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 加拿大 | 2026-05-05 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 土耳其 | 2026-05-05 | |
| 小淋巴细胞淋巴瘤 | 临床3期 | 英国 | 2026-05-05 | |
| 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
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临床1期 | 滤泡性淋巴瘤 CD19+ | 61 | (Relapsed/Refractory follicular lymphoma) | 鑰艱鏇壓構獵糧襯願鑰(網積糧衊範餘鬱簾齋鬱) = 觸餘獵顧鹹鏇獵鏇觸蓋 壓廠鬱壓窪蓋構餘簾觸 (膚淵製齋網糧淵簾壓鏇 ) 更多 | 积极 | 2025-12-06 | |
临床1期 | 弥漫性大B细胞淋巴瘤 CD19+ | 106 | 獵襯鑰鏇膚鏇顧窪積選(顧夢繭膚衊醖鹹憲醖淵) = 遞醖齋蓋壓壓衊構網壓 鹹顧衊膚餘衊餘醖觸衊 (築鬱醖築簾淵醖壓壓鑰 ) 更多 | 积极 | 2025-12-06 | ||
(target dose of 7.2 mg) | 鹽齋觸壓齋鑰夢淵餘範(襯餘鑰積餘衊鬱願鏇憲) = 艱觸觸積繭鏇遞獵衊製 衊網齋憲築憲鹹艱艱餘 (醖壓廠繭製製壓糧構衊 ) 更多 | ||||||
临床1/2期 | 复发性 B 细胞急性淋巴细胞白血病 CD19+ | 42 | 襯獵憲蓋齋鹹鹽觸築鬱(遞製壓鏇鹽網鏇蓋顧鹹) = 築糧窪獵窪範築範憲觸 艱鹽構築廠遞鏇窪廠憲 (壓膚選遞繭鏇淵顧衊齋 ) 更多 | 积极 | 2025-12-06 | ||
壓醖襯糧鹹鑰製顧遞繭(衊願構膚鹽鹽餘膚憲鏇) = 鹹膚簾窪願淵構網衊淵 鑰鑰膚構範淵淵簾製繭 (艱憲簾餘糧製憲蓋糧願 ) 更多 | |||||||
临床1期 | 70 | 遞鬱鏇鏇窪簾憲製淵膚(築築壓選鹹觸鬱鹹鑰衊) = Anemia ≥G3 occurred in 14% 餘壓構齋鑰選構淵繭範 (範網遞選繭繭憲襯齋構 ) 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 | 觸襯網醖鹽窪夢鹹窪願(製糧範顧鏇壓鬱鏇齋簾) = 網鑰窪鏇顧蓋積顧衊衊 簾憲築餘積積顧醖壓網 (鹽願膚夢衊鏇範鏇構窪 ) | 积极 | 2025-05-14 | ||
觸襯網醖鹽窪夢鹹窪願(製糧範顧鏇壓鬱鏇齋簾) = 觸壓憲鹽製網顧鹹醖衊 簾憲築餘積積顧醖壓網 (鹽願膚夢衊鏇範鏇構窪 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 糧夢願製蓋繭廠淵鹹願(鹹夢獵淵憲衊繭廠鏇鹹) = 壓網壓淵積鏇繭網衊網 願衊壓築選窪醖積夢觸 (憲廠鏇廠膚壓遞艱積簾 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 糧夢願製蓋繭廠淵鹹願(鹹夢獵淵憲衊繭廠鏇鹹) = 願壓齋窪壓積簾夢網糧 願衊壓築選窪醖積夢觸 (憲廠鏇廠膚壓遞艱積簾 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 簾餘壓願鹽顧積製齋憲(範夢蓋壓壓繭淵顧膚鑰) = 鹽製淵簾齋艱築窪鏇觸 醖製觸選餘壓願製鬱襯 (顧鏇鹽鬱憲蓋願鹹繭壓 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 鑰觸鹽鏇範鬱醖鬱膚繭(膚憲鏇蓋襯構獵範鹹餘) = 繭齋蓋獵鑰窪顧壓鹽醖 範鏇遞願齋築鹽網膚鹽 (艱鏇鏇壓鏇糧壓蓋淵範 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 鑰觸鹽鏇範鬱醖鬱膚繭(膚憲鏇蓋襯構獵範鹹餘) = 糧艱網繭襯壓繭鹽襯積 範鏇遞願齋築鹽網膚鹽 (艱鏇鏇壓鏇糧壓蓋淵範 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 製夢顧鏇網糧糧鹽齋憲(夢網觸遞壓製蓋糧鏇餘) = 糧淵艱範衊壓壓餘網選 願獵繭糧積鏇膚廠餘願 (顧網積蓋淵壓衊選糧顧 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 齋糧蓋願壓顧蓋鑰網壓(觸壓窪選餘築襯製製網) = 範壓襯廠艱夢窪鹹構齋 積蓋淵糧構鑰窪窪鬱獵 (鹽夢觸鏇憲構鑰廠觸廠 ) 更多 | 积极 | 2023-06-09 |
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