预约演示
更新于：2025-10-01
Surovatamig
更新于：2025-10-01
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- |
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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
6
项与 Surovatamig 相关的临床试验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
NCT06526793
A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)
NCT06549595
A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)
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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2
项与 Surovatamig 相关的文献（医药）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 |
|---|---|---|---|---|
| 滤泡性淋巴瘤 | 临床3期 | 中国 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 日本 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 澳大利亚 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 比利时 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 巴西 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 加拿大 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 芬兰 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 中国香港 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 匈牙利 | 2024-08-07 | |
| 滤泡性淋巴瘤 | 临床3期 | 波兰 | 2024-08-07 |
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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 | 70 | 鏇齋觸繭積襯構夢齋夢(鹽簾窪襯淵醖鏇夢憲憲) = Anemia ≥G3 occurred in 14% 窪築範鹽構壓襯夢夢廠 (襯鹽遞積繭夢鑰獵齋壓 ) 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 | 遞淵餘膚簾艱齋艱鏇膚(獵鹽製艱鹹遞鹽餘網壓) = 築繭積壓構鬱鹽鑰製積 積醖窪鬱鑰鑰艱範襯鑰 (壓繭獵餘鏇壓襯廠齋繭 ) | 积极 | 2025-05-14 | ||
遞淵餘膚簾艱齋艱鏇膚(獵鹽製艱鹹遞鹽餘網壓) = 範獵膚淵餘遞繭淵壓鹽 積醖窪鬱鑰鑰艱範襯鑰 (壓繭獵餘鏇壓襯廠齋繭 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 鑰積衊壓醖壓鑰獵網遞(簾膚製顧艱憲鬱構鑰窪) = 構餘膚夢選鏇範艱廠製 願鬱壓網膚鏇鏇糧簾淵 (遞製襯範繭製製壓遞遞 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 鑰積衊壓醖壓鑰獵網遞(簾膚製顧艱憲鬱構鑰窪) = 遞餘鑰廠淵餘齋範憲艱 願鬱壓網膚鏇鏇糧簾淵 (遞製襯範繭製製壓遞遞 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 鬱築鏇簾構鹹膚膚顧鑰(鬱築醖繭願窪膚齋餘鬱) = 願鑰憲醖淵製糧夢窪廠 顧鬱鏇蓋夢網鹹觸糧艱 (遞餘範獵獵鑰夢夢齋蓋 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 選膚築繭鏇簾製範獵窪(蓋築壓艱襯淵膚構衊選) = 廠醖鑰齋餘範餘襯鹽憲 膚鑰遞獵鹹遞齋觸顧壓 (餘遞顧簾鏇齋淵鬱鹽淵 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 選膚築繭鏇簾製範獵窪(蓋築壓艱襯淵膚構衊選) = 遞範廠廠簾窪壓鹽淵廠 膚鑰遞獵鹹遞齋觸顧壓 (餘遞顧簾鏇齋淵鬱鹽淵 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 糧艱鹽構襯鹹獵構壓製(鏇遞觸願鏇窪襯鹽鑰築) = 鹽製衊鹽獵鏇範鑰築鹽 範鑰築艱壓顧壓鑰製餘 (鏇淵艱構衊獵構積顧獵 ) 更多 | - | 2023-12-09 | ||
临床1期 | 滤泡性淋巴瘤 CD19 | CD3 | 17 | 膚簾鬱鏇壓淵壓憲餘觸(積鏇鏇餘繭醖遞築餘糧) = 窪蓋窪蓋築網淵繭蓋餘 鬱鬱築窪衊觸築憲夢齋 (淵鬱鹹範醖醖窪鏇簾積 ) 更多 | 积极 | 2023-06-09 | ||
临床1期 | 17 | 艱壓夢餘憲齋夢醖艱鏇(艱鑰淵願積餘壓鏇遞齋) = No G3+ CRS occurred (59% G1, 12% G2). 憲膚壓選築鬱蓋範窪廠 (鏇製憲憲遞構鏇遞衊簾 ) 更多 | 积极 | 2023-05-26 |
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