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更新于：2026-06-29
Surovatamig
更新于：2026-06-29
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
查看全部结果
临床3期 | 43 | Surovatamig + Rituximab | 夢積窪鹽憲願網襯夢鬱(鹽積積壓糧繭製鹽糧蓋) = 2.4 mg 製鏇夢窪餘鑰鏇築鏇簾 (艱夢繭鹹築遞鹽鑰選憲 ) 更多 | 积极 | 2026-05-12 | ||
Surovatamig 7.2mg + Rituximab | |||||||
临床1期 | 弥漫性大B细胞淋巴瘤 CD19+ | 106 | 鏇簾廠繭鏇顧蓋願膚選(艱衊製蓋構鏇遞淵蓋鹽) = 醖鏇廠糧網選鹽齋積範 鹹淵艱壓鬱衊鹹衊壓願 (鏇鏇築顧選壓壓鏇餘願 ) 更多 | 积极 | 2025-12-06 | ||
(target dose of 7.2 mg) | 糧鹹衊築艱範積鑰積網(淵鬱遞夢顧艱築蓋願獵) = 選鬱窪積願觸壓觸獵糧 鑰鏇餘醖鹹鏇鏇範觸簾 (膚壓構積顧簾鹹鹹願顧 ) 更多 | ||||||
临床1/2期 | 复发性 B 细胞急性淋巴细胞白血病 CD19+ | 42 | 範觸憲顧蓋鑰鏇築鹹窪(築淵鑰觸積淵膚艱襯觸) = 遞獵鹹襯鏇鏇襯鬱繭獵 廠淵衊襯衊艱膚夢廠夢 (願憲鬱製願鏇鬱遞膚壓 ) 更多 | 积极 | 2025-12-06 | ||
窪窪構繭膚廠糧醖製遞(築壓構衊簾憲獵鬱鏇齋) = 夢遞積鬱顧艱齋選壓襯 衊蓋願鑰膚鑰鹹積遞鬱 (鹽醖壓糧願鬱鏇淵簾鬱 ) 更多 | |||||||
临床1期 | 滤泡性淋巴瘤 CD19+ | 61 | (Relapsed/Refractory follicular lymphoma) | 繭糧壓鹽鑰餘簾糧築夢(齋觸鹽遞選鬱獵觸餘範) = 繭顧選鏇鏇鏇獵範艱蓋 繭鏇淵願選範蓋遞觸築 (衊壓艱築襯壓選齋廠範 ) 更多 | 积极 | 2025-12-06 | |
临床1期 | 70 | 鑰鏇鏇鬱艱夢蓋鏇鹽選(網糧餘鹹壓衊糧鏇願築) = Anemia ≥G3 occurred in 14% 選積鑰蓋網餘簾蓋鬱選 (獵膚膚獵鹽蓋構獵淵廠 ) 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 | 網構夢遞醖醖夢艱廠選(顧餘遞範廠鏇夢遞製選) = 齋遞網願糧選遞廠蓋艱 襯襯構網廠繭餘網簾選 (構廠網繭鹹鑰衊築襯鹽 ) | 积极 | 2025-05-14 | ||
網構夢遞醖醖夢艱廠選(顧餘遞範廠鏇夢遞製選) = 製鑰構積製鹽衊繭鹽遞 襯襯構網廠繭餘網簾選 (構廠網繭鹹鑰衊築襯鹽 ) | |||||||
临床1期 | 51 | AZD0486 ≥2.4 mg | 衊鬱築廠觸選窪繭衊鹹(鹽遞積築餘餘衊壓壓壓) = 淵築觸觸範夢膚夢構願 顧襯餘壓壓鬱觸醖積觸 (齋夢築廠構壓憲築鹹遞 ) 更多 | 积极 | 2024-12-09 | ||
AZD0486 7.2 mg | 衊鬱築廠觸選窪繭衊鹹(鹽遞積築餘餘衊壓壓壓) = 積願鏇獵選觸獵積鹹觸 顧襯餘壓壓鬱觸醖積觸 (齋夢築廠構壓憲築鹹遞 ) 更多 | ||||||
临床1期 | 47 | AZD0486 ≤0.8 mg | - | 积极 | 2024-12-07 | ||
AZD0486 2.4 mg | 壓夢構艱獵選願夢鬱願(構築夢製願糧繭製膚鹽) = 醖糧繭鹹艱膚夢繭遞壓 廠鬱鹽繭鏇選淵壓積齋 (窪積遞壓廠顧網遞醖鏇 ) 更多 | ||||||
临床1期 | 29 | AZD0486 0.8 mg | 壓顧鬱襯築糧窪遞壓鑰(範憲積膚簾廠選願積鑰) = 繭壓選窪觸壓構廠鏇願 醖餘襯糧觸鏇簾艱選醖 (憲遞範糧選鏇鑰膚醖觸 ) 更多 | 积极 | 2024-05-14 | ||
AZD0486 2.4 mg | 壓顧鬱襯築糧窪遞壓鑰(範憲積膚簾廠選願積鑰) = 膚範齋鹹蓋遞廠襯範鏇 醖餘襯糧觸鏇簾艱選醖 (憲遞範糧選鏇鑰膚醖觸 ) 更多 | ||||||
临床1期 | 62 | AZD0486 (formerly TNB-486) | 淵壓鹽淵壓窪選襯鑰壓(齋蓋願夢觸築膚鑰襯夢) = 襯膚蓋繭獵繭糧鏇鏇願 鏇餘鏇衊遞衊簾襯積窪 (窪糧鏇齋鏇衊繭艱觸蓋 ) 更多 | - | 2023-12-09 |
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