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

The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.

开始日期2024-10-10

申办/合作机构

宜明凯尔生物医药技术（上海）有限公司

CTR20231000

/ Recruiting临床1/2期

注射用IMM0306联合来那度胺治疗复发/难治CD20阳性B细胞非霍奇金淋巴瘤的Ib/Ⅱa 期临床研究

Ib期：剂量递增阶段：评估IMM0306与来那度胺联合用药的安全性和耐受性，确定最大耐受剂量（MTD）（如有）和推荐2期剂量（RP2D）；初步评估IMM0306与来那度胺联合用药的抗肿瘤疗效；评估IMM0306与来那度胺联合用药的免疫原性；评估IMM0306与来那度胺联合用药的药代动力学（PK）特征；探索IMM0306的暴露与疗效、安全性的相关性（如数据允许）；探索生物标志物与安全性的相关性；探索淋巴细胞亚群变化与疗效相关性； IIa期：队列扩展阶段评估IMM0306与来那度胺联合用药的抗肿瘤疗效；进一步评估IMM0306与来那度胺联合用药的抗肿瘤疗效；进一步评估IMM0306与来那度胺联合用药的安全性和耐受性；注射用IMM0306与来那度胺联合用药在CD20阳性B-NHL受试者中的免疫原性；基于群体PK分析方法，表征IMM0306在晚期实体瘤受试者中的PK特征（如数据允许）；探索IMM0306的暴露与疗效、安全性之间的相关性（如数据允许）。

开始日期2023-06-07

申办/合作机构

宜明昂科生物医药技术（上海）股份有限公司

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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项与阿沐瑞芙普α 相关的文献（医药）

2023-03-01·Leukemia

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: Zhang, Li ; Liu, Dandan ; Peng, Liang ; Yu, Jifeng ; Tian, Wenzhi ; Guo, Huiqin ; Song, Yongping ; Zhao, Gui ; Liu, Sijin ; Tu, Xiaoping ; Li, Song ; Chen, Dianze ; 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 ; Song, Yongping ; Li, Zhiming ; Zhou, Keshu ; Zhang, Mingzhi ; Yu, Li ; Wang, Zhen ; 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.

项与阿沐瑞芙普α 相关的新闻（医药）

2025-06-24

·美柏医健

2024年底的BD潮，再爆一波

继2024年下半年的BD狂潮后，T细胞衔接器再起波澜。6月23日，和铂医药以4700万美元的首付款和近期里程碑付款+高达6.23亿美元的额外付款及未来销售分成将BCMAxCD3双抗HBM7020大中华区外的权益授予大塚制药。据和铂医药官网显示，HBM7020主要的开发适应症为自身免疫疾病。近日，罗氏公布了全球首个CD20xCD3双抗Mosunetuzumab（以下统简称：Mosu）自免临床数据，该药已经在2022年中获得欧盟批准治疗复发性或难治性滤泡淋巴瘤。在本次公布治疗中度系统性红斑狼疮（SLE）初步临床数据中，表现出可有效清除外周血B细胞并长期维持的疗效。值得注意的是，过去全球T细胞衔接器自免疾病开发走在最前沿的为IGM Biosciences和Cullinan Therapeutics，两者核心开发T细胞衔接器均为肿瘤转自免，前者在年初停止开发两款CD3双抗并裁员73%，后者则是最近从智翔金泰引进了BCMAxCD3双抗，被外界视为一种信号。2025年下半年，将会有大量的T细胞衔接器公布首次临床数据，这预计将为T细胞衔接器的BD交易热度再送上一把火。01BCMAxCD3双抗，领航者打样2025年以来，BCMAxCD3双抗领域仍在持续发生BD交易，包括智翔金泰与Cullinan的交易、和铂医药与大塚制药的交易等，并且首付款有逐渐攀升的迹象，这很可能得益于赛道先驱的珠玉在前。2024年9月，《新英格兰医学杂志》发表的一篇研究数据显示，一名有6年病史的SLE患者在接受BCMAxCD3双抗Teclistamab治疗后能够快速且在无药物维持的情况下，生物标志物降至正常或接近正常水平，患者粘膜皮肤和肌肉骨骼症状完全消失，实现了完全缓解。在不错的疗效背景下，我们核心需要了解的是该病例给予的剂量和安全性。剂量方面，该患者接受了Teclistamab注射（剂量逐步递增），第1、7天分别为0.03和0.6mg/kg；第2周和第5周为1.5mg/kg（最终剂量）；安全性方面，安全性方面，这例患者的不良反应包括2级细胞因子释放综合征（CRS）、肺炎、鼻窦炎和低丙种球蛋白血症，与Teclistamab在MM患者报告的副作用相似。对比Teclistamab在MM的临床设计，可以发现该药在SLE和MM的剂量相似（爬坡再到1.5mg/kg），尽管Teclistamab相比其他BCMA疗法具备安全性优势，不过CRS发生率很高和有一定程度的免疫效应细胞相关神经毒性综合征（ICANS）发生率，这在自免适应症中有些难以接受。当然，原本就定向肿瘤适应症的T细胞衔接器管线出现这样的问题也很正常，关键在于后续迭代分子或者剂量降低后的疗效和安全性能否兼顾，Teclistamab暂时没有给出示范。同样在NEJM，康诺亚最新发布的BCMAxCD3双抗CM336在自身免疫性溶血性贫血（AIHA）数据加了一把火，在两名多线治疗失败（包括CD19 CAR-T、BTK抑制剂）的AIHA患者中，两名患者在接受治疗后分别在第13天获得部分缓解（PR）、在第21天获得完全缓解（CR），并且疗效持续超过半年；安全性方面，仅观察到1级皮肤硬结及低丙球蛋白血症，没有发生严重不良反应，亦未出现CRS或ICANS，未见感染事件。（两名AIHA患者治疗情况图源：NEJM）CM336在AIHA患者中初步的疗效和较低的安全性风险给后面的自免BCMAxCD3双抗打了个样，这可能在未来促成更多的赛道交易。02罗氏Mosunetuzumab数据，评价几何？Mosu在EULAR 2025大会上公布了治疗系统性红斑狼疮（SLE）的1b期的结果，该研究一共纳入了15名成年SLE患者，筛查时系统性红斑狼疮疾病活动指数 2000（SLEDAI-2K）总分≥4，为中度SLE患者，试验分为2个剂量探索队列（非分割，21天）和3个剂量递增队列（分割，28天），所有患者在完成最后一次治疗后须至少随访12个月监测安全性。疗效层面，在2个非分割低剂量组（1.6mg及5mg）尽管可以快速耗竭B细胞，但短时间内B细胞数量会快速反弹；在3个分割高剂量组，接受Mosu治疗的所有患者B细胞数量降至检测下限且能够持续疗效200天左右；另外，分割高剂量组患者在接受Mosu治疗后SLEDAI-2K评分均出现评分降低，部分患者能够降低至2分，而少数初始评分较高的患者在270天评分能降低到6分。安全性方面，15例患者中有4例发生CRS（均为1~2级），均为首次给药后出现；另外，常见副作用还有淋巴细胞减少、感染等，均为轻度；还有1例最高剂量组的患者在接受爬坡期后37天死于间质性肺炎，后研究者和申办方评估与Mosu无关。目前基于已披露B细胞耗竭策略的T细胞衔接器临床数据而言，Mosu在疗效维持时间、安全性应该算中规中矩，而疗效当前仅有中度SLE患者人体数据，需要未来进一步在重度SLE患者层面评估。但仅仅以当下的数据情况来说，Mosu在自免疾病想要大展拳脚，压力不小，毕竟CAR-T的B细胞耗竭深度带来的疗效和持续时间摆在那里，当然其安全性和可及性也有待考察。至少我们认为，Mosu的数据大概率不会对后续新的CD20xCD3双抗数据披露带来肃杀气氛，不妨期待一下后续康诺亚的CM355、嘉和生物的GB261后续数据读出。03机会投射全球TCE自免管线资产超过30款，但大部分都在临床前，而光是治疗SLE进入临床的TCE管线就超过10条，而这些管线将在未来2年内密集披露数据。Cullinan的CD3xCD19双抗CLN-978是海外市场关注的焦点之一，该分子在经工程改造对CD19有很高的结合亲和力（即便是CD19表达量极低的B细胞、临床前显示优于安进的贝林妥欧单抗）、对CD3具有更低的亲和力（降低安全性风险）及可实现皮下注射（注射便捷性）。早CLN-978治疗弥漫性大B细胞淋巴瘤（DLBCL）临床小样本数据显示，3名患者每周接受30mg皮下注射，首次给药后96小时内2名具有可检测基线B细胞的患者外周B细胞分别减少了93%和98%，而两名肿瘤体积较大的患者在首次给药后出现了一级CRS事件，其他不良事件为低级别或于机制相关事件（如淋巴细胞减少症）；而CLN-978的一期SLE临床，将在2025Q4获得初步数据。另一个关注度很高的便是默沙东高价买下的同润生物的CD3xCD19双抗CN201，在2024年ASCO大会上，CN201初步肿瘤临床数据，51例患者中15例患者（29.4%）出现CRS（仅2例为3级），未见患者出现ICANS，这样的安全性表现在同类型的TCE中展现出BIC潜力，这也让投资者对其后续数据倍加期待。（图源：雪球用户chuminhua）密集的数据催化，可能会带动MNC或海外资金对于T细胞衔接器资产的进一步热潮，如果数据不及预期，可能会引发另外一个方向的探索和BD机会——髓系细胞疗法（MCE）。MCE国内比较代表性管线为CD20xCD47融合蛋白IMM0306，一方面阻断CD47-SIRPα信号通路激活巨噬细胞吞噬功能，同时高亲和力结合CD20，单次给药即可实现B细胞清零并维持3个月以上，而如TCE代表性药物Teclistamab需要每4-6周重复给药以维持疗效；IMM0306有望在近期公布治疗SLE的早期临床数据，以便进一步验证其成药性和安全性。另外，赛诺菲在2025年3月宣布以6亿美元的首付款收购Dren Bio的MCE管线DR-0201也验证了MCE路径的潜力，目前，DR-0201正在开展两项I期临床试验，分别针对复发或难治性B细胞非霍奇金淋巴瘤和自身免疫性疾病，DR-0201在临床前和临床研究中均显示出显著的B细胞清除效果。结语TCE的自免路径验证已经初见曙光，后面就是Me Better和BIC的事情了，相信国产分子在这块能够发光发热，而未来相信有更多中国底色的Newco，能够被MNC高价收购。而下一个BD潮，会不会是MCE？

引进/卖出免疫疗法细胞疗法临床申请

2025-06-16

·抗体圈

聚焦Trap：宜明昂科会复制再生元的传奇吗？

1990年代中期，当专注于神经系统药物开发的再生元（Regeneron）屡屡受挫，在相关药物的开发中闯得头破血流时，外部邀请到前默沙东总裁罗伊·瓦格洛斯（Roy Vagelos）担任公司董事会主席。老爷子来到再生元的第一件事，就建议团队不要“死盯”在退行性神经疾病领域，可以将研究重点放在可以充分表征生物学特征和更快评估临床益处的适应症领域，可以重点关注细胞受体相关的Traps技术平台。随后，再生元快速调整了研发方向，虽说不能算一帆风顺，但也成功开发了IL1R-Fc融合蛋白Arcalyst（列洛西普），以及VEGFR-Fc融合蛋白Eylea（阿柏西普）等多款药物，从此走向了一代生物技术公司的传奇之路。几十年过去了，虽说单一技术路线很难支撑一家药企的价值，但是基于配体与受体生物学机制的巨大差异，Traps技术平台的仍然在多个靶点中体现出差异化的特性。以大热的CD47和SIRPα介导的“别吃我”信号通路来说，CD47主要表达在肿瘤细胞和红细胞表面，Sirpα主要表达在巨噬细胞表面。因此靶向CD47抗体活性太强会导致红细胞裂解的副作用，活性太弱则又很难起到抗肿瘤作用，受体SIRPα-Fc融合蛋白的形式显然一定程度规避了以上矛盾。宜明昂科开发的SIRPα-Fc融合蛋白IMM01（替达派西普），通过SIRPα中断CD47-SIRPα相互作用阻断“别吃我”信号，同时基于活性的Fc区域通过Fc-FcγR受体结合激活“吃我”信号，充分调节巨噬细胞和T细胞介导的免疫功能，最大化肿瘤杀伤的情况下，也保证了药物安全性，为当前唯一一款在血液瘤治疗三期的CD47-SIRPα信号通路药物。经PD-1抗体治疗后复发难治的cHL患者中，IMM01 （替达派西普）与替雷利珠单抗（PD-1抗体）联用二期临床取得了69.7%的响应率，完全响应率更是达到24.2%，并显著优于其它PD-1联用疗法，三期临床已于2024年7月启动。IMM01 （替达派西普）与阿扎胞苷联用针对治疗一线慢性粒单核细胞白血病（CMML）的数据显示，总体缓解率（ORR）为84.6%及完全缓解率为46.2%，显著优于阿扎胞苷主要临床试验中的历史数据，ORR及CR率分别37%-54%及8%-18%。目前IMM01 （替达派西普）与阿扎胞苷联用治疗一线CMML也已经进入三期临床阶段。此外IMM01 （替达派西普）与阿扎胞苷联用治疗1L MDS的二期临床数据显示，总体缓解率（ORR）为64.7%及完全缓解率为33.3%，无论是疗法还是安全性数据，均优于阿扎胞苷单药数据，也即将启动三期临床。除了CD47-SIRPα信号通路，在近两年进展显著的PD-1（L1）/VEGF双抗疗法方面，宜明昂科同样采用了差异化的策略，IMM2510（珀维拉芙普α）采用VEGFR融合PD-L1抗体的方式。一方面VEGFR可以阻断包括VEGF-A在内的更广泛的VEGF，同时Fc区域增强的ADCC功能，可以诱导免疫抑制的PD-L1阳性肿瘤细胞的直接杀伤。作为全球第四款公布临床数据的PD-1（L1）/VEGF双抗疗法，IMM2510在非小细胞肺癌的一期临床数据显示，其在接受过包括PD-1疗法的后线患者中，取得了23%的客观响应率，在患者人群的横向比较下，IMM2510的竞争力甚至不弱于康方的依沃西单抗，以及BioNtech的BNT327，即将启动联合化疗的一线非小细胞肺癌三期临床，未来值得期待。在连接先天性免疫和获得性免疫方面，宜明昂科开发了开了SIRPα-PD-L1抗体融合蛋白IMM2520，基于巨噬细胞、自然杀伤细胞和T细胞之间的相互作用，IMM2520能够产生显著的协同作用。IMM2520于2023年3月启动一期临床试验，截至 2024底，已有26例患者入组并给药，初步疗效安全性良好。观察到1例PR和2例肿瘤缩小超过10% 的SD, 这例PR为免疫治疗失败的小细胞肺患者，期待后续更多临床数据的更新。在SIRPα的迭代药物开发方面，宜明昂科同样基于受体和Fc区域的巧妙设计，开发了SIRPα-CD20抗体融合蛋白，基于巨噬细胞的全面激活，以及增加的ADCP和ADCC效应，全面调节免疫系统。作为全球首款进入临床试验阶段的CD47和CD20双靶向双特异性药物，IMM0306（阿沐瑞芙普α）与来那度胺联用治疗R/R FL的Ib期临床数据显示，其客观响应率达到了90.9%，完全响应率达到了27.3%。刚刚召开的2025 ASCO会议上，2a期临床数据更新显示，IMM0306（阿沐瑞芙普α）与来那度胺联用治疗R/R FL的客观响应率达到了81.8%，完全响应率达到了45.5%，疗法进一步提升，后期临床更值得期待。基于B细胞耗竭的全面调节，IMM0306（阿沐瑞芙普α）不仅仅用于抗肿瘤的药物开发，基于其独特机制，宜明昂科还将扩展其用于自身免疫疾病的开发。临床前的Faslpr小鼠LN疾病模型中，CD47敲除导致肾小球基地膜增厚缓解并显著降低自身抗体和补体沉积，显示IMM0306（阿沐瑞芙普α）具有显著治疗潜力。2025年开始，IMM0306（阿沐瑞芙普α）将先后启动系统性红斑狼疮（SLE）、视神经脊髓炎（NMOSD）和狼疮肾炎（LN）等自免型疾病临床试验。除了自免相关的非肿瘤领域，宜明昂科还在代谢领域继续扩展Traps药物理念，并成立子公司宜明凯尔（Immunecare）。基于CD47在人动脉粥样硬化斑块组织细胞中高表达，阻断CD47信号可诱导大鼠血管中的巨噬细胞对斑块的吞噬作用，IMM01（替达派西普）同样在治疗动脉粥样硬化方面有巨大潜力。全新开发的ActRIIA-Fc融合蛋白IMC-003，与默沙东的sotatercept相比，有更强的结合活性及信号阻断活性，在MCT诱导的肺动脉高压（PAH）模型上体现出优异的体内药效，即将进入临床阶段，是国内治疗PAH除sotatercept外（申报上市阶段）进度最快的同靶点创新分子。靶向GLP-1和ActRIIA的双特异性分子IMC-010同样糅合了Traps设计，通过靶向 GLP-1和 Activin A/ActRIIs信号通路，有望为代谢降低提供更优治疗方案，目前正处于体内药效研究阶段。在CB17-SCID小鼠模型中，连续5周每周一次给药显示我们的多个候选分子均显示出良好的增肌效果，未来有望同时满足减少脂肪质量的同时保留瘦体重的需求，成为肥胖市场的潜力药物。宜明昂科此前专注于CD47-SIRPα信号通路的药物研发，虽然采用了Traps相关差异化的研发策略，但是基于该领域的持续失败，宜明昂科仍然遭到不少的怀疑，但是其在质疑中仍然寻求临床突破，将相关疗法推进到三期。同时，随着全球药物市场的快速变化，宜明昂科也对管线进行了快速调整，PD-L1/VEGFR融合蛋白IMM2510（珀维拉芙普α）即将启动非小细胞肺癌一线三期临床。同时基于对Traps技术和Fc功能设计的深入理解，快速扩展到自免领域和代谢领域。未来，基于对于药物结构的深耕，生物学机制的充分理解，以及多疾病领域的布局，宜明生物显然将迎来属于自己的“再生元”时刻。参考文献：宜明昂科官网识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期临床2期

2025-06-07

·药明康德

客观缓解率达100%的抗体疗法；100%降解目标蛋白的潜在“first-in-class”口服降解剂…… | 一周盘点

本期看点1. 靶向Clever-1的单克隆抗体bexmarilimab与标准治疗（SoC）联用治疗初治高危骨髓增生异常综合征（HR-MDS）患者的早期临床试验结果亮眼，客观缓解率（ORR）达100%。2. 口服靶向抗癌化合物ibrilatazar联合化疗治疗III/IV期鳞状非小细胞肺癌（SQ-NSCLC）患者的1/2a期临床试验结果积极，与历史对照相比，联合治疗组的中位总生存期（OS）接近翻倍（22.5个月对比11.3个月）。3. Kymera Therapeutics公司的口服STAT6降解剂KT-621在一项1期研究的所有≥50 mg的多剂量递增（MAD）组中表现积极，患者血液与皮肤中的目标蛋白均达成完全降解。Bexmarilimab：公布1期联合治疗试验数据Faron Pharmaceuticals公司宣布，其靶向Clever-1的单克隆抗体bexmarilimab的一项1期研究结果已发表在《柳叶刀-血液学》（Lancet Haematology）杂志上。该研究旨在评估bexmarilimab联合SoC治疗高危骨髓增生异常综合征和复发/难治性（r/r）急性髓系白血病（AML）患者的安全性和有效性。Bexmarilimab是Faron公司全资拥有的研究性免疫疗法，旨在通过靶向髓系细胞功能和激活免疫系统，克服对现有疗法的耐药性并优化临床疗效。Bexmarilimab能与巨噬细胞上的免疫抑制受体Clever-1结合，该受体有助于肿瘤生长和转移（即帮助癌症躲避免疫系统）。通过靶向巨噬细胞上的Clever-1受体，bexmarilimab可改变肿瘤微环境，将巨噬细胞从免疫抑制（M2）状态重编程为免疫刺激（M1）状态，上调干扰素的产生，启动免疫系统攻击肿瘤，使癌细胞对标准治疗敏感。此次公布的结果显示，bexmarilimab联合阿扎胞苷在初治和低甲基化药物（HMA）治疗失败的HR-MDS患者中的ORR分别为100%和89%。HMA治疗失败的MDS患者的估计中位OS为13.4个月，r/r AML患者为8.1个月。两名HMA治疗失败的MDS患者在治疗后接受了造血干细胞移植（HSCT）。此外，治疗后患者的骨髓免疫生物标志物较基线水平提升了近3倍。在67%的HMA治疗失败的MDS患者中观察到HLA-DR分子增加，进一步支持bexmarilimab的作用机制。安全性方面，bexmarilimab联合治疗的耐受性良好，未观察到剂量限制性毒性。大多数治疗伴发不良事件（TEAE）为轻度至中度，仅6%与bexmarilimab相关。Ibrilatazar（ABTL0812）：公布1/2a期联合治疗试验数据AbilityPharma公司宣布，其评估ibrilatazar（ABTL0812）联合化疗（紫杉醇/卡铂）治疗III/IV期鳞状非小细胞肺癌患者的1/2a期临床试验ENDOLUNG的数据已发表在Lung Cancer杂志上。Ibrilatazar是一种潜在“first-in-class”、差异化的口服靶向抗癌化合物，通过诱导内质网应激和抑制PI3K/Akt/mTOR通路来引发自噬。在临床试验中，ibrilatazar对子宫内膜癌和肺癌患者显示出临床益处。此外，它在包括肺癌、子宫内膜癌、胰腺癌、神经母细胞瘤和胶质母细胞瘤等癌症类型的动物模型中展示了强有力的临床前概念验证。此次公布的结果显示，与历史对照相比，ibrilatazar联合化疗在所有疗效终点均显示出改善，包括：ibrilatazar联合治疗组的总缓解率为52%，历史对照为31.7%；ibrilatazar联合治疗组的中位无进展生存期（PFS）为6.2个月，历史对照为4.2个月；ibrilatazar联合治疗组的中位OS为22.5个月，历史对照为11.3个月。安全性方面，ibrilatazar联合化疗表现出良好的安全性。在紫杉醇/卡铂基础上加入ibrilatazar的安全性与历史对照中紫杉醇/卡铂单独使用时的安全性一致，并未带来除紫杉醇/卡铂本身已知不良事件之外的显著新增安全性风险。KT-621：公布1期临床试验数据Kymera Therapeutics公司公布其潜在“first-in-class”口服STAT6降解剂KT-621在1期健康受试者研究中的积极结果。数据显示，KT-621在每日一次口服给药下，于所有高于1.5 mg剂量水平中实现了超过90%的平均血液STAT6降解；在所有≥50 mg的MAD组中，更在血液与皮肤中均达成完全降解。此外，KT-621对Th2炎症相关生物标志物TARC和Eotaxin-3的中位降低幅度分别高达37%与63%，表现优于或相当于现有获批药物。KT-621在本项试验中展现出优异的安全性，未观察到严重不良事件或与治疗相关的不良事件，整体耐受性与安慰剂无明显差异。Kymera公司指出，KT-621的临床表现已显著优于其预设的产品特征目标，进一步验证了其“生物制品口服化”开发策略的可行性。当前，KT-621正在中重度特应性皮炎（AD）患者中开展1b期BroADen试验，预计将在2025年第四季度公布数据，并计划分别于2025年第四季度与2026年第一季度启动针对AD与哮喘的两项2b期临床研究。ISB 2001：公布1期临床试验的新数据Ichnos Glenmark Innovation公司公布了其三特异性抗体ISB 2001用于治疗复发/难治性多发性骨髓瘤（RRMM）的1期研究的新数据。ISB 2001同时靶向多发性骨髓瘤（MM）细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。此次公布的结果显示，在经过大量治疗的患者群体中，7个活性剂量（≥50 μg/kg）组患者的持续总缓解率为79%，完全缓解/严格完全缓解（CR/sCR）率为30%。所有接受治疗的患者的总缓解率为74%，包括2例接受较低剂量治疗的患者。安全性方面，ISB 2001具有良好的安全性，大多数患者在数据截止时仍在接受治疗。EBC-129：公布1期临床试验的新数据新加坡实验药物研发中心（EDDC）公布了其在研抗体偶联药物（ADC）EBC-129的一项1期临床试验的新数据。EBC-129靶向CEACAM5和CEACAM6上保守的肿瘤特异性N256糖基化位点，这两种蛋白在肿瘤发生和转移中起关键作用。该ADC的毒性有效载荷是微管蛋白抑制剂MMAE，该药物已在其他上市的ADC中被广泛测试并获批用于临床，且已显示出与PD-1抑制剂之间的协同作用。此次公布的结果显示，EBC-129在21名此前接受过大量治疗的胰腺导管腺癌（PDAC）患者中显示出积极的总缓解率和延长的无进展生存期，包括那些之前接受过SoC（通常含有紫杉烷类药物）的患者。在接受1.8 mg/kg和2.2 mg/kg剂量治疗的患者中，总缓解率分别为25%和20%，疾病控制率（DCR）达87.5%和63.6%，中位PFS分别为19周和12周。EBC-129在迄今为止接受治疗的58例患者中显示出可控的安全性，观察到的主要治疗相关不良事件（TRAE）为无并发症的中性粒细胞减少和输液相关反应。IMC-002：公布1期联合治疗试验的中期数据ImmuneOncia Therapeutics公司公布了其下一代CD47靶向抗体IMC-002与lenvatinib联用治疗晚期肝细胞癌（HCC）患者的1b期临床试验的中期结果。IMC-002是一款全人源化IgG4单克隆抗体，通过阻断CD47-SIRPα相互作用，促进巨噬细胞对肿瘤细胞的吞噬作用。该抗体疗法可以在保证高疗效的同时最大限度地减少与红细胞的结合并避免血液学毒性。此次公布的结果显示，IMC-002表现出良好的安全性特征，未报告中性粒细胞减少或血小板减少，96%的不良事件为1/2级。在疗效可评估的10名患者中，有3名达到部分缓解（PR），DCR达80%，中位PFS为8.3个月。两名患者的治疗时间已超过一年，提示该疗法可能带来持久的临床获益。参考资料（可上下滑动查看）[1] ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/immuneoncia-announces-interim-results-from-phase-1b-clinical-trial-of-next-generation-cd47-antibody-imc-002-at-asco-2025-302470514.html[2] Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://ir.pasithea.com/news-events/press-releases/detail/122/pasithea-therapeutics-presents-updated-interim-data-from[3] Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/01/3091475/0/en/Allogene-Therapeutics-Provides-Updated-Phase-1-Data-Highlighting-Durable-Responses-with-ALLO-316-in-Heavily-Pretreated-Advanced-Renal-Cell-Carcinoma-at-ASCO.html[4] MYTX-011, a cMET-targeting antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated dose escalation results in the phase 1 KisMET-01 study. Retrieved June 5, 2025, from https://ascopubs-org.libproxy1.nus.edu.sg/doi/10.1200/JCO.2025.43.16_suppl.8613[5] NervGen Pharma Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord Injury. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091725/0/en/NervGen-Pharma-Reports-Positive-Topline-Data-from-the-Chronic-Cohort-of-its-Phase-1b-2a-Clinical-Trial-Evaluating-NVG-291-in-Spinal-Cord-Injury.html[6] Kymera Therapeutics Announces Positive First-in-Human Results from Phase 1 Healthy Volunteer Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091701/0/en/Kymera-Therapeutics-Announces-Positive-First-in-Human-Results-from-Phase-1-Healthy-Volunteer-Clinical-Trial-of-KT-621-a-First-in-Class-Oral-STAT6-Degrader.html[7] Erasca Announces IND Clearance for Potential First-in-Class and Best-in-Class Pan-KRAS Inhibitor ERAS-4001. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091800/0/en/Erasca-Announces-IND-Clearance-for-Potential-First-in-Class-and-Best-in-Class-Pan-KRAS-Inhibitor-ERAS-4001.html[8] Diakonos Oncology Presents Promising Phase I Results of Dubodencel (DOC1021) for the Treatment of Glioblastoma at the ASCO 2025 Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/diakonos-oncology-presents-promising-phase-i-results-of-dubodencel-doc1021-for-the-treatment-of-glioblastoma-at-the-asco-2025-annual-meeting-302469896.html[9] GV20 Therapeutics Presents Updated Phase 1 Monotherapy Data on GV20-0251 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/gv20-therapeutics-presents-updated-phase-1-monotherapy-data-on-gv20-0251-at-the-asco-annual-meeting-2025-302463359.html[10] Mersana Therapeutics Reports Additional Positive Interim Phase 1 Clinical Data for Emi-Le in Oral Presentation at 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091831/0/en/Mersana-Therapeutics-Reports-Additional-Positive-Interim-Phase-1-Clinical-Data-for-Emi-Le-in-Oral-Presentation-at-2025-ASCO-Annual-Meeting.html[11] Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations. Retrieved May 30, 2025 from https://www-merck-com.libproxy1.nus.edu.sg/news/merck-announces-mk-1084-an-investigational-kras-g12c-inhibitor-shows-antitumor-activity-in-phase-1-trial-of-patients-with-advanced-colorectal-cancer-and-non-small-cell-lung-cancer-whose-tumors-harbo/[12] IN8bio Presents Positive Phase 1 Data of INB-200 in Newly Diagnosed GBM Demonstrating Prolonged Progression-Free Survival. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091745/0/en/IN8bio-Presents-Positive-Phase-1-Data-of-INB-200-in-Newly-Diagnosed-GBM-Demonstrating-Prolonged-Progression-Free-Survival.html[13] OnCusp Therapeutics Announces Encouraging Initial Phase 1a Results from Ongoing First-in-Human Study Evaluating its CDH6-Directed Antibody-Drug Conjugate, CUSP06, in Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/oncusp-therapeutics-announces-encouraging-initial-phase-1a-results-from-ongoing-first-in-human-study-evaluating-its-cdh6-directed-antibody-drug-conjugate-cusp06-in-platinum-refractoryresistant-ovarian-cancer-and-other-advanced--302470621.html[14] Perspective Therapeutics Highlights Updated Interim Data from its Ongoing Phase 1/2a Clinical Trial of [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3091346/0/en/Perspective-Therapeutics-Highlights-Updated-Interim-Data-from-its-Ongoing-Phase-1-2a-Clinical-Trial-of-212Pb-VMT-%CE%B1-NET-at-the-2025-ASCO-Annual-Meeting.html[15] AbCellera Receives Authorization from Health Canada to Initiate a Phase 1 Clinical Trial of ABCL575. Retrieved June 5, 2025, from https://investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-a-Phase-1-Clinical-Trial-of-ABCL575/default.aspx[16] Faron announces publication of full Phase I BEXMAB study data in Lancet Haematology. Retrieved June 5, 2025, from https://faron.com/releases-and-publications/faron-announces-publication-of-full-phase-i-bexmab-study-data-in-lancet-haematology/[17] Enterome presents positive Phase 1/2 MSS/pMMR metastatic colorectal cancer data in patients treated with EO4010 OncoMimics™ immunotherapy plus nivolumab at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3090836/0/en/Enterome-presents-positive-Phase-1-2-MSS-pMMR-metastatic-colorectal-cancer-data-in-patients-treated-with-EO4010-OncoMimics-immunotherapy-plus-nivolumab-at-ASCO-2025.html[18] Experimental Drug Development Centre Announces the Presentation of Updated Data from the Phase 1 Study of Antibody-Drug Conjugate EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/experimental-drug-development-centre-announces-the-presentation-of-updated-data-from-the-phase-1-study-of-antibody-drug-conjugate-ebc-129-at-the-2025-annual-meeting-of-the-american-society-of-clinical-oncology-asco-302467763.html[19] Full Dose-Escalation Data Show Continued High Response Rates and Favorable Safety Profile of ISB 2001, a First-in-Class BCMA × CD38 × CD3 Trispecific Antibody, for the Treatment of Relapsed/Refractory Multiple Myeloma. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091923/0/en/Full-Dose-Escalation-Data-Show-Continued-High-Response-Rates-and-Favorable-Safety-Profile-of-ISB-2001-a-First-in-Class-BCMA-CD38-CD3-Trispecific-Antibody-for-the-Treatment-of-Relap.html[20] Cardiff Oncology Announces Positive Data from Investigator-Initiated Trial of Onvansertib in Combination with Paclitaxel in Metastatic Triple-Negative Breast Cancer Presented at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3092323/0/en/Cardiff-Oncology-Announces-Positive-Data-from-Investigator-Initiated-Trial-of-Onvansertib-in-Combination-with-Paclitaxel-in-Metastatic-Triple-Negative-Breast-Cancer-Presented-at-AS.html[21] Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/lilly-presents-first-clinical-data-for-its-investigational-next-generation-fr-targeting-adc-in-platinum-resistant-ovarian-cancer-at-the-2025-asco-annual-meeting-302470018.html[22] Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-ALK7 for the Treatment of Obesity. Retrieved June 5, 2025, from https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-initiates-phase-12a-study-aro-alk7[23] Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2025, from https://obsidiantx.com/news-releases/obsidian-therapeutics-announces-positive-clinical-data-from-obx-115-in-patients-with-advanced-melanoma-in-ongoing-multicenter-study-at-the-2025-american-society-of-clinical-oncology-asco-annual-meet/[24] Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/johnson--johnson-unveils-first-in-human-results-for-pasritamig-showing-early-anti-tumor-activity-in-prostate-cancer-302470142.html[25] Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response. Retrieved June 5, 2025, from https://www.businesswire.com/news/home/20250601016939/en/Initial-Data-from-the-ARC-20-Study-of-Casdatifan-Plus-Cabozantinib-Showed-Nearly-Half-of-Patients-with-Metastatic-Kidney-Cancer-Had-a-Confirmed-Response[26] 에이비엘, 'B7-H4x4-1BB' 삼중 1b/2상 "국내 IND 승인". Retrieved June 5, 2025, from https://www.biospectator.com/news/view/25313[27] Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic Fibrosis. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093440/0/en/Sionna-Therapeutics-Announces-Positive-Phase-1-Data-for-NBD1-Stabilizers-SION-719-and-SION-451-and-Advances-Both-Programs-in-Clinical-Development-for-Cystic-Fibrosis.html[28] Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107). Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093575/0/en/Moleculin-Reports-Positive-Topline-Efficacy-Results-from-U-S-Phase-1B-2-Clinical-Trial-Evaluating-Annamycin-for-the-Treatment-of-Soft-Tissue-Sarcoma-Lung-Metastases-MB-107.html[29] REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202. Retrieved June 5, 2025 from https://ir.regenxbio.com/news-releases/news-release-details/regenxbio-reports-new-positive-functional-data-phase-iii[30] AbilityPharma’s IBRILATAZAR (ABTL0812) doubles overall survival in patients with squamous non-small cell lung cancer. Retrieved June 5, 2025 from https://abilitypharma.com/en/main-menu/media-center-2/press-release/abilitypharma%E2%80%99s-ibrilatazar-(abtl0812)-doubles-overall-survival-in-patients-with-squamous-non-small-cell-lung-cancer免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

临床结果免疫疗法临床2期临床1期

100 项与阿沐瑞芙普α 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
系统性红斑狼疮	临床2期	-	宜明凯尔生物医药技术（上海）有限公司	2024-10-10
CD20阳性弥漫性大B细胞淋巴瘤	临床2期	中国	宜明昂科生物医药技术（上海）股份有限公司	2023-06-07
滤泡性淋巴瘤	临床2期	中国	宜明昂科生物医药技术（上海）股份有限公司	2023-06-07
套细胞淋巴瘤	临床2期	中国	宜明昂科生物医药技术（上海）股份有限公司	2023-06-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床2期	-	宜明昂科生物医药技术（上海）股份有限公司	2023-05-01
弥漫性大B细胞淋巴瘤	临床2期	-	宜明昂科生物医药技术（上海）股份有限公司	2023-05-01
惰性B细胞非霍奇金淋巴瘤	临床2期	-	宜明昂科生物医药技术（上海）股份有限公司	2023-05-01
难治性边缘区淋巴瘤	临床2期	-	宜明昂科生物医药技术（上海）股份有限公司	2023-05-01
巨球蛋白血症	临床2期	-	宜明昂科生物医药技术（上海）股份有限公司	2023-05-01
CD20阳性的B细胞非霍奇金淋巴瘤	临床2期	中国	宜明昂科生物医药技术（上海）股份有限公司	2020-03-02

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06535412 (NEWS)	临床1/2期	系统性红斑狼疮	-	阿沐瑞芙普a	簾範繭衊鏇壓衊選餘鏇(鏇積鹽選憲鹹網鹹網艱) = 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。餘鏇廠鹽窪顧鏇鑰遞構 (壓構艱鹽壓獵簾積簾簾 )	积极	2025-08-05
NCT05771883 (Phase II, ASCO2025)	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	範遞齋窪積襯築獵網艱(襯衊遞壓簾鑰製鏇簾蓋) = 窪鬱顧淵選遞網廠觸獵觸觸製蓋壓願鬱憲遞餘 (鑰繭選糧廠獵遞襯膚淵 ) 更多	积极	2025-05-30
NCT05805943 (Phase 1/2 study, Pubmed \| J Hematol Oncol)	临床1/2期	难治性B细胞淋巴瘤 CD20 +	48	Amulirafusp alfa	簾鏇觸願膚鬱繭衊淵鑰(夢鹽艱餘獵鹽襯願鏇壓) = 顧範築鹽範鹹製膚鹹餘範獵蓋觸顧憲壓鏇衊窪 (繭廠築廠構壓艱遞憲繭 ) 更多	积极	2024-12-18
ASH2024	N/A	CD20阳性的B细胞非霍奇金淋巴瘤	-	IMM0306 1.6 mg/kg + Lenalidomide 20 mg	膚選積齋鏇鹹鹽積廠鏇(壓觸淵顧製齋獵艱選鹽) = 63.6% 窪繭壓選憲糧鬱製憲選 (遞製範遞鑰鏇襯觸製範 ) 更多	-	2024-12-08
NCT05805943 (ASH2024) 人工标引	临床1期	CD20阳性的B细胞非霍奇金淋巴瘤	48	IMM0306	糧觸選襯鹹壓醖鬱築鬱(夢築鹹積窪鹽淵糧願憲) = 憲製構艱觸顧壓窪鹽願積獵簾膚選繭簾醖繭醖 (鏇積膚夢鹽鏇糧網鏇顧 ) 更多	积极	2024-12-07
NCT05805943 (ASH2024) 人工标引	临床1期	CD20阳性的B细胞非霍奇金淋巴瘤	48	IMM0306 (r/r follicular lymphoma (FL))	糧觸選襯鹹壓醖鬱築鬱(夢築鹹積窪鹽淵糧願憲) = 觸遞觸齋製衊夢鹽壓糧積獵簾膚選繭簾醖繭醖 (鏇積膚夢鹽鏇糧網鏇顧 ) 更多	积极	2024-12-07
NCT05771883 (NEWS) 人工标引	临床1/2期	滤泡性淋巴瘤 \| 边缘区B细胞淋巴瘤	27	阿沐瑞芙普α + 来那度胺 (R/R滤泡性淋巴瘤（FL）)	顧構餘膚醖醖願繭繭蓋(鏇觸壓遞繭夢鬱顧簾窪) = 顧簾網構夢獵膚窪願鏇築餘築餘窪蓋憲鬱簾獵 (網簾顧齋糧餘艱鏇構繭 ) 更多	积极	2024-12-06
NCT05771883 (NEWS) 人工标引	临床1/2期	滤泡性淋巴瘤 \| 边缘区B细胞淋巴瘤	27	阿沐瑞芙普α + 来那度胺 (R/R边缘区淋巴瘤（MZL）)	顧構餘膚醖醖願繭繭蓋(鏇觸壓遞繭夢鬱顧簾窪) = 觸鏇糧範鏇夢鑰遞淵餘築餘築餘窪蓋憲鬱簾獵 (網簾顧齋糧餘艱鏇構繭 )	积极	2024-12-06
NCT05771883 (ESMO2024) 人工标引	临床1期	CD20阳性的B细胞非霍奇金淋巴瘤 CD20-positive	11	Amulirafusp alfa lenalidomide6 mg/kg	觸糧願憲鏇膚製繭簾鹹(夢網餘艱餘醖醖夢顧廠) = Two DLTs (grade 4 PLT decreased without bleeding) were observed at 2.0 mg/kg IMM0306 + 20 mg Lenalidomide dose level. 觸窪築憲膚鹽壓膚繭淵 (築餘襯齋齋蓋獵鏇遞築 ) 更多	积极	2024-09-15
NCT05805943 (ESMO2024) 人工标引	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	鹽觸網夢繭構憲夢鏇襯(夢襯膚鏇膚築艱淵淵襯) = 築衊夢網齋壓繭網餘壓選選糧憲構衊鏇鑰窪艱 (鹽壓鏇鹽鏇選簾艱積衊 ) 更多	积极	2024-09-15
NCT05771883 (Phase I, ASCO2024)	临床1期	CD20阳性的B细胞非霍奇金淋巴瘤 CD20-positive	8	IMM0306 1.6 mg/kg + Lenalidomide 20 mg	壓鏇顧鏇繭鹽繭醖鏇憲(築鑰鑰襯網夢積範壓夢) = One pt experienced treatment related serious adverse event 鬱繭憲鏇簾顧壓繭遞構 (膚顧簾齋觸製鬱鹹構淵 )	积极	2024-05-24
NCT05805943 (phase I study of IMM0306, ASCO2024)	临床1期	CD20阳性的B细胞非霍奇金淋巴瘤	48	IMM0306 0.04 mg/kg	膚獵選膚顧遞網淵壓鏇(餘鹹艱築衊鹹製襯艱憲) = 廠鑰襯鹹繭積築鹽鏇夢鏇夢製餘鏇鬱觸顧觸願 (壓鑰觸獵網遞簾鑰糧範 ) 更多	积极	2024-05-24
NCT05805943 (phase I study of IMM0306, ASCO2024)	临床1期	CD20阳性的B细胞非霍奇金淋巴瘤	48	IMM0306 0.1 mg/kg	膚獵選膚顧遞網淵壓鏇(餘鹹艱築衊鹹製襯艱憲) = 衊獵膚膚觸獵糧範廠觸鏇夢製餘鏇鬱觸顧觸願 (壓鑰觸獵網遞簾鑰糧範 ) 更多	积极	2024-05-24