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更新于：2026-01-21
Amulirafusp alfa
阿沐瑞芙普α
更新于：2026-01-21
概要
基本信息
药物类型 双特异性抗体、抗体融合蛋白 |
别名 IMC-002、IMM 0306 |
作用方式 抑制剂 |
作用机制 CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、CD47抑制剂(分化群47抑制剂) |
在研适应症 |
非在研适应症 |
非在研机构- |
权益机构- |
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 27145L
来源: *****
Sequence Code 523903788H
来源: *****
关联
10
项与 阿沐瑞芙普α 相关的临床试验CTR20243045
一项评价IMC-002治疗视神经脊髓炎谱系疾病的安全性和有效性的多中心、随机、阳性对照的Ib/Ⅲ期临床研究
NCT06557174
A Phase Ib/III Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
NCT06535412
A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
100 项与 阿沐瑞芙普α 相关的临床结果
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100 项与 阿沐瑞芙普α 相关的转化医学
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100 项与 阿沐瑞芙普α 相关的专利（医药）
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3
项与 阿沐瑞芙普α 相关的文献（医药）2023-03-01Leukemia
IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, exerts excellent cancer killing efficacy by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcɣR engagement by simultaneously binding to CD47 and CD20 of B cells
Letter
作者: Liu, Dandan ; Zhang, Li ; Peng, Liang ; Yu, Jifeng ; Tian, Wenzhi ; Guo, Huiqin ; Song, Yongping ; Zhao, Gui ; Liu, Sijin ; Chen, Dianze ; Tu, Xiaoping ; Li, Song ; Zhang, Wei ; Bai, Xing ; Zhang, Ruliang ; Yang, Chunmei ; Jiang, Zhongxing
CD47, as the 'don't eat me' signal, interacts with the inhibitory signal-regulatory protein alpha (SIRPα) receptor expressed by myeloid cells and activated NK cells and is overexpressed in different malignancies, causing tumors to escape the phagocytosis of macrophages.Here, we describe the antitumor mechanism of IMM0306, a fusion protein of CD20 monoclonal antibody (mAb) with the CD47 binding domain of SIRPα , by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcγR engagement by simultaneously binding to CD47 and CD20 of B cells in different mouse xenograft tumor models.IMM0306 is a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα on both heavy chains, that was constructed and produced using an inhouse developed CHO-K1 cell expression system; whose binding activity was analyzed by flow cytometry.The phagocytosis and in vitro anti-tumor activity of IMM0306 were evaluated by antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cell-mediated cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC) assays.The ADCC assay showed that IMM0306 has strong ADCC induced by activating NK cells through enhanced Fc/ FcγRRIIIa interaction.In conclusion, our data demonstrated that IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα , exerts excellent cancer killing efficacy by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcγR engagement by simultaneously binding to CD47 and CD20 of B cells.We conclude the mechanism of action of IMM0306 by blocking the CD47 'don't eat me' signal and activating the Fc-receptor 'eat me' signal of CD20 with a strong ADCP to make the B-cell fully killed, whereas CD47 mAbs and rituximab can only either block the CD47 'don't eat me' signal or activate the Fc-receptor 'eat me' signal of CD20 with limited ADCP to make the limited B-cell killed.The Fc segment of the recombinant protein in IMM0306 is IgG1 and has been modified by ADCC-enhanced genetic engineering.Therefore, it has strong in vivo efficacy (through ADCC and ADCP).For other CD47 BsAbs, because the CD47 antibody itself combines with red blood cells, IgG1 cannot be selected; otherwise, it will have severe anemia toxicity.Therefore, this data revealed that IMM0306 has a safer profile and superior therapeutic potential than other CD47 mAbs and BsAbs.
Journal of Hematology & Oncology
Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study
Article
作者: Shi, Yuankai ; Li, Zhiming ; Zhou, Keshu ; Song, Yongping ; Zhang, Mingzhi ; Wang, Zhen ; Yu, Li ; Meng, Wei ; Yang, Jianliang ; Jing, Hongmei ; Lu, Qiying ; Tian, Wenzhi
BACKGROUND:
Amulirafusp alfa (IMM0306) is a fusion protein of CD47 binding domain of signal-regulatory protein alpha (SIRPα) with CD20 monoclonal antibody on both heavy chains. This study aimed to evaluate the safety and preliminary efficacy of amulirafusp alfa in relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL).
METHODS:
We enrolled patients with CD20 + r/r B-NHL who had previously received at least two lines of therapy to receive a single-dose of amulirafusp alfa in the first 2 weeks, followed by a multiple-dose period, in which the patients received the same intravenous dose every week in 4-week cycles. The primary endpoints were to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of amulirafusp alfa.
RESULTS:
Between May 22, 2020 and February 10, 2022, 48 patients with r/r B-NHL were enrolled and received amulirafusp alfa at the doses of 40-2000 μg/kg. As of the data cut-off date of April 18, 2024, no dose-limiting toxicity was observed, and the MTD was not reached. The dose of 2000 μg/kg was identified as the RP2D. All grades and ≥ grade 3 treatment-related adverse events (TRAEs) occurred in 48 (100%) and 33 (68.8%) patients, respectively. The most common ≥ grade 3 TRAEs were lymphocyte count decreased (28/48, 58.3%), white blood cell count decreased (10/48, 20.8%), absolute neutrophil count decreased (9/48, 18.8%) and anemia (5/48, 10.4%). At the doses of 800-2000 μg/kg, objective response rate in follicular lymphoma and marginal zone lymphoma was 41.2% (7/17, 95% confidence interval [CI] 18.4-67.1) and 33.3% (2/6, 95% CI 3.7-71.0), respectively.
CONCLUSION:
Amulirafusp alfa showed favorable safety profile and preliminary efficacy in patients with r/r B-NHL, meriting further investigation. Trial registration NCT05805943.
HAEMATOLOGICA
Lymphoma cell-driven IL-16 is expressed in activated B-cell-like diffuse large Bcell lymphomas and regulates the pro-tumor microenvironment
Article
作者: Hao, Mu ; Li, Ru ; Wang, Jingya ; Guan, Xuwen ; Qiu, Lugui ; Fang, Teng ; Wang, Yi
The activated B-cell–like subtype of diffuse large B-cell lymphoma (ABC-DLBCL) displays a worse outcome than the germinal center B-cell–like subtype (GCB-DLBCL). Currently, targeting tumor microenvironment (TME) is the promising approach to cure DLBCL with profound molecular heterogeneity, however, the factors affecting the tumor-promoting TME of ABCDLBCL are elusive. Here, cytokine interleukin-16 (IL-16) is expressed in tumor cells of ABCDLBCL and secreted by the cleavage of active caspase-3. The serum IL-16 levels are not only a sensitive marker of treatment response but also positively correlated with unfavorable prognosis in DLBCL patients. While IL-16 shows few direct promotional effects on tumor cell growth in vitro, its bioactive form significantly promotes tumor progression in vivo. Mechanically, IL-16 increases the infiltration of macrophages by the chemotaxis of CD4+ monocytes in the TME enhancing angiogenesis, and the expression of cytokine IL-6 and IL-10, as well as decreasing T cell infiltration to accelerate tumor progression. This study demonstrates that IL-16 exerts a novel role in coordinating the bidirectional interactions between tumor progression and the TME. IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, reverses the tumorpromoting effects of IL-16,which provides new insight into treatment strategy in ABC-DLBCL.
100 项与 阿沐瑞芙普α 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 |
|---|---|---|---|---|
| CD20阳性滤泡性淋巴瘤 | 临床3期 | 中国 | 2026-01-05 | |
| 视神经脊髓炎 | 临床2期 | - | 2024-10-10 | |
| 系统性红斑狼疮 | 临床2期 | - | 2024-10-10 | |
| CD20阳性弥漫性大B细胞淋巴瘤 | 临床2期 | 中国 | 2023-06-07 | |
| 边缘区B细胞淋巴瘤 | 临床2期 | 中国 | 2023-06-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床2期 | - | 2023-05-01 | |
| 弥漫性大B细胞淋巴瘤 | 临床2期 | - | 2023-05-01 | |
| 惰性B细胞非霍奇金淋巴瘤 | 临床2期 | - | 2023-05-01 | |
| 难治性边缘区淋巴瘤 | 临床2期 | - | 2023-05-01 | |
| 巨球蛋白血症 | 临床2期 | - | 2023-05-01 |
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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1/2期 | CD20阳性滤泡性淋巴瘤 CD20-positive | 38 | Amulirafusp alfa 1.6 mg/kg iv QW + Lenalidomide 20 mg po QD | 艱積窪憲齋艱築獵窪構(築繭築製壓艱廠觸淵觸) = 觸積鑰鏇鑰鹽願廠襯遞 糧鏇餘窪廠鹹顧膚憲糧 (壓鹽醖顧餘憲網膚齋艱 ) 更多 | 积极 | 2025-12-06 | |
Amulirafusp alfa 1.6 mg/kg iv QW + Lenalidomide 20 mg po QD (CD20-refractory patients) | 艱積窪憲齋艱築獵窪構(築繭築製壓艱廠觸淵觸) = 鹽鹹鑰衊淵願齋廠簾餘 糧鏇餘窪廠鹹顧膚憲糧 (壓鹽醖顧餘憲網膚齋艱 ) 更多 | ||||||
临床1/2期 | - | 鹹觸顧網願鹹鬱夢選網(艱淵獵糧範鬱簾醖遞壓) = 初步数据显示，IMM0306在不同剂量组中均展现出良好的疗效和安全性，预示该药物分子在自免疾病治疗中的巨大潜力。 憲糧鹹醖鹽積鹹選製獵 (獵夢襯壓壓醖衊鹽鏇壓 ) | 积极 | 2025-08-05 | |||
临床2期 | CD20阳性滤泡性淋巴瘤 CD20-positive | 34 | Amulirafusp alfa 1.6 mg/kg + Lenalidomide 20 mg | 窪簾鹹糧膚鹽築醖蓋鏇(顧壓構範糧簾醖齋鏇獵) = 遞積築遞選鹹醖鑰遞艱 衊鏇糧淵壓範蓋艱蓋簾 (醖鑰簾簾膚構鹹夢獵鑰 ) 更多 | 积极 | 2025-05-30 | |
临床1/2期 | 难治性B细胞淋巴瘤 CD20 + | 48 | 衊淵憲鏇積憲鏇獵顧鬱(範遞艱範築簾繭憲糧膚) = 廠觸積簾顧齋願窪壓艱 鑰選構積餘齋餘艱顧蓋 (襯範廠觸簾艱繭積壓糧 ) 更多 | 积极 | 2024-12-18 | ||
N/A | - | 鹽簾範觸廠襯遞範鹹艱(艱膚構鬱選淵淵壓衊觸) = 63.6% 壓鬱選膚選廠觸願鏇壓 (鏇淵鹽窪衊鬱窪網膚衊 ) 更多 | - | 2024-12-08 | |||
临床1期 | 48 | 衊蓋遞觸衊襯網艱窪壓(衊遞簾選觸觸遞糧蓋構) = 醖襯鏇鏇觸範鏇蓋製願 製範襯鏇窪簾醖範鹽鏇 (鏇窪廠憲艱積顧製鹽膚 ) 更多 | 积极 | 2024-12-07 | |||
(r/r follicular lymphoma (FL)) | 衊蓋遞觸衊襯網艱窪壓(衊遞簾選觸觸遞糧蓋構) = 艱膚襯廠襯鬱廠顧繭廠 製範襯鏇窪簾醖範鹽鏇 (鏇窪廠憲艱積顧製鹽膚 ) 更多 | ||||||
临床1/2期 | 27 | 淵壓鹽選蓋鬱觸糧襯願(鬱鹹製願獵築鬱鬱襯選) = 餘獵襯艱簾醖餘鏇衊壓 襯膚製襯獵蓋繭鏇廠廠 (觸餘獵糧鏇糧範顧鏇艱 ) 更多 | 积极 | 2024-12-06 | |||
淵壓鹽選蓋鬱觸糧襯願(鬱鹹製願獵築鬱鬱襯選) = 網壓願積選築夢鏇餘選 襯膚製襯獵蓋繭鏇廠廠 (觸餘獵糧鏇糧範顧鏇艱 ) | |||||||
临床1期 | CD20阳性的B细胞非霍奇金淋巴瘤 CD20-positive | 11 | 願構鏇鏇鬱繭顧憲鏇壓(夢鏇夢構積鏇憲鹽顧願) = Two DLTs (grade 4 PLT decreased without bleeding) were observed at 2.0 mg/kg IMM0306 + 20 mg Lenalidomide dose level. 窪鬱網積範鬱遞鹽餘鬱 (糧範鹹構網願網鹽鹽淵 ) 更多 | 积极 | 2024-09-15 | ||
临床2期 | CD20阳性的B细胞非霍奇金淋巴瘤 CD20 Positive | 16 | Amulirafusp alfa (IMM0306) 2.0 mg/kg | 齋簾積網願衊獵夢夢窪(獵糧衊網艱遞膚鑰衊壓) = 鹹網夢夢廠糧構衊窪觸 餘遞積願願淵齋襯遞鹹 (衊襯壓夢憲廠鏇窪製範 ) 更多 | 积极 | 2024-09-15 | |
临床1期 | CD20阳性的B细胞非霍奇金淋巴瘤 CD20-positive | 8 | 鹽衊廠鬱醖蓋觸鹽願鏇(艱襯餘鑰襯網淵顧憲憲) = One pt experienced treatment related serious adverse event 觸獵網廠餘夢構膚淵夢 (憲艱鬱淵網壓鑰蓋願鏇 ) | 积极 | 2024-05-24 |
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