利妥昔单抗(Rituximab) - 药物靶点：CD20_在研适应症：心脏移植排斥反应，肝移植排斥反应，肺移植排斥反应_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

IDEC-C2B8-anti-CD20、Ristova、Rituximab (Genetical Recombination)

+ [14]

靶点

CD20

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)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

治疗领域

肿瘤免疫系统疾病感染+ [11]

在研适应症

心脏移植排斥反应肝移植排斥反应肺移植排斥反应+ [142]

非在研适应症

急性双系白血病急性移植物抗宿主病成人急性髓性白血病+ [142]

原研机构

Genentech, Inc.

在研机构

Roche Diagnostics GmbHGenmab, Inc.

ADC Therapeutics SA

+ [41]

非在研机构

University of Nebraska

Rutgers State University of New Jersey

Biogen, Inc.

+ [41]

权益机构

上海罗氏制药有限公司

青岛百洋医药股份有限公司

Biogen, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1997-11-26),

非霍奇金淋巴瘤

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)

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结构/序列

Sequence Code 27145L

来源: *****

Sequence Code 83181H

来源: *****

关联

2,548

项与利妥昔单抗相关的临床试验

NCT07097363

/ Not yet recruiting临床2期IIT

A Pilot Study of Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas

This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.

开始日期2026-01-01

申办/合作机构

University of Washington

[+1]

NCT06015750

/ Not yet recruiting临床4期

An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ?) for Hypophosphatasia (RESTORE)

The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).

开始日期2025-11-19

申办/合作机构

Alexion Pharmaceuticals, Inc.

NCT06510309

/ Not yet recruiting临床2期IIT

A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL).
The names of the study drugs involved in this study are:
* Venetoclax (a type of inhibitor)
* Rituximab (a type of antibody)

开始日期2025-10-01

申办/合作机构

Beth Israel Deaconess Medical Center, Inc.

[+1]

100 项与利妥昔单抗相关的临床结果

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100 项与利妥昔单抗相关的转化医学

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100 项与利妥昔单抗相关的专利（医药）

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11,266

项与利妥昔单抗相关的文献（医药）

2025-12-31·RENAL FAILURE

The efficacy and safety of rituximab monotherapy in the new onset pediatric idiopathic nephrotic syndrome: a randomized controlled clinical trial

Article

作者: He, Si-Yi ; Zhao, Jing-Li ; Dou, Ya-Lan ; Wang, Jing-Jing ; Shen, Hui-Jun ; Liu, Fei ; Zhang, Xiao-Jing ; Fu, Hai-Dong ; Li, Qiu-Yu ; Huang, Ling-Fei ; Lu, Zhi-Hong ; Sheng, Ai-Qin ; Yan, Wei-Li ; Feng, Chun-Yue ; Mao, Jian-Hua

BACKGROUND:

Nephrotic syndrome (NS) is a common form of glomerular disease in children, characterized by a high propensity for relapse. Prolonged use of glucocorticoids (GCs) can result in various side effects. Rituximab (RTX) may be considered as an initial treatment option for primary nephrotic syndrome in pediatric patients.

METHODS:

We conducted a prospective, single-center, randomized controlled trial (RCT) to evaluate whether the initial use of RTX monotherapy is superior to GC therapy in treating pediatric idiopathic NS and to assess its safety. The primary outcome and secondary outcomes were compared between the two groups.

RESULTS:

A total of 24 pediatric patients were included in the study, comprising 19 males and 5 females. After six weeks of treatment, the complete remission (CR) rate in the GC group was significantly higher than that in the RTX group (100% vs 33.3%). Compared with the RTX group, the GC group had a shorter time to first remission (14.25 d vs. 9.5 d). During the follow-up period, none of the patients in the RTX group who achieved CR experienced relapse, with the longest relapse-free duration being 79 weeks. In the GC group, nine patients experienced relapse with the longest relapse-free period being 94 weeks. No serious adverse events occurred in either group. The cumulative steroid dosage was not statistically different between the 2 groups (p = 0.41).

CONCLUSION:

Although the CR rate of children with idiopathic NS treated with RTX alone is significantly lower, the relapse rate among responders to RTX is also lower than that of the GC treatment.

2025-12-31·Hematology

Dose adjusted EPOCH-R is superior to RCHOP in frontline treatment of mediastinal large B cell lymphoma

Article

作者: Shahin, Omar ; Abufara, Alaa ; Al-Rwashdeh, Mohammad ; Muqbel, Ro’a ; Halahleh, Khalid ; Al-rabi, Kamal ; Al-Ibraheem, Akram ; Abed, Nebras Abu ; Farfoura, Heba ; Abdel-Razeq, Hikmat ; Ma'koseh, Mohammad ; Yaseen, Abeer ; Rahman, Zaid Abdel

INTRODUCTION:

Primary Mediastinal Large B Cell Lymphoma (PMLBCL) is a rare but aggressive B-cell lymphoma. This study compares the outcomes and toxicities of DA-EPOCH-R (Dose-adjusted etoposide, prednisolone, vincristine, cyclophosphamide, and doxorubicin in combination with rituximab) and RCHOP-21 (rituximab, cyclophosphamide, doxorubicin, and vincristine, every 21 days) in the treatment of newly diagnosed PMLBCL.

METHODS:

We retrospectively reviewed the medical records of adults (>18 years) diagnosed with PMLBCL and treated at our center from 2010 to 2023. Baseline characteristics were compared using chi-square and Mann Whitney U-tests. Survival outcomes were analysed using Kaplan Meier and log-rank tests.

RESULTS:

Eighty-seven patients were included, with a median age of 30 years (range: 18-55), 48 patients (55.2%) received RCHOP-21, and 39 patients (44.8%) received DA-EPOCH-R. Radiotherapy was more frequent in the RCHOP-21 group (66.6% vs 15%, p < 0.001). DA-EPOCH-R achieved a higher complete metabolic response (CMR) (92% vs 69%, p = 0.007). After a median follow-up of 47.4 months, patients treated with DA-EPOCH-R had superior overall survival (OS) and progression free survival (PFS); 3-year OS rates were 94.4% vs 69.8% (p = 0.01) and the 3-year PFS rates were 86.7% vs 62.2% (p = 0.016), particularly in patients with aa-IPI >1. Post-chemotherapy delta SUV max <0.75, and <0.7 correlated with relapse and mortality, respectively. Grade III-IV anemia and non-hematological toxicities were more frequent in the DA-EPOCH-R, but no therapy-related deaths occurred.

CONCLUSIONS:

DA-EPOCH-R improves CMR, PFS, and OS compared to R-CHOP-21 with radiotherapy in PMLBCL, particularly in high-risk patients. Longer follow-up is needed to assess long-term toxicities.

2025-12-01·Blood Research

Real-world data analysis of survival outcomes of patients with primary mediastinal large B-cell lymphoma treated with immunochemotherapy: the role of consolidative radiation therapy

Article

作者: Lee, Yong-Pyo ; Yoon, Sang Eun ; Oh, Dongryul ; Ko, Young Hyeh ; Kim, Seok Jin ; Kim, Won Seog ; Cho, Junhun

Abstract:

Purpose:

Primary mediastinal large B-cell lymphoma (PMBCL) is a rare subtype of diffuse large B-cell lymphoma. Radiation therapy (RT) has served as the primary treatment option for PMBCL; however, its role has been questioned with the advent of intensified immunochemotherapy. This study aimed to investigate the role of consolidative RT in the primary treatment of PMBCL.

Methods:

This single-center retrospective study analyzed the survival outcomes of 65 patients newly diagnosed with PMBCL. The patients were divided into three treatment groups: (1) EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab), (2) R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), and (3) R-CHOP with consolidative RT.

Results:

The objective response and complete remission rates were 86.2% and 63.1%, respectively, with 3-year progression-free survival (PFS) and overall survival (OS) rates of 72% and 81%, respectively. All patients in the R-CHOP + RT group achieved an objective response with better PFS) than those who did not receive consolidative RT (p = 0.028), although there was no significant difference in OS (p = 0.102). Consolidative RT benefited patients with an initially bulky disease or insufficient end-of-treatment response. The predictive value of 18F-fluorodeoxyglucose positron-emission tomography-computed tomography (PET-CT) in assessing the treatment response in PMBCL was revalidated, showing that patients who achieved negative end-of-treatment PET-CT had significantly better survival outcomes than others.

Conclusions:

R-CHOP is a useful alternative regimen when intensified chemotherapy is not feasible. Consolidative RT should be considered in cases with an initially bulky disease and insufficient end-of-treatment response.

2,082

项与利妥昔单抗相关的新闻（医药）

2025-08-18

·药事纵横

42款国产抗体新药爆发，中国创新药驶向全球快车道

2025年上半年，NMPA批准的9款国产抗体新药名单上，恒瑞的降脂药、百济的胆道癌新药赫然在列——这是中国创新药"黄金五年"的缩影：2021年至今，42款国产1类抗体新药密集上市，中美审批数量首次持平。当全球TOP40抗体药创造2100亿美元市场，中国药企正从"仿制跟跑"转向"原创领航"。但狂欢背后，8个生物药集采的寒流已至，本土巨头如何平衡创新投入与价格血战？一、抗体药成黄金赛道在生物医药领域，单克隆抗体药物已成为全球研发的焦点和市场增长的引擎。随着技术的进步和临床需求的推动，抗体药市场呈现出蓬勃发展的态势。从市场规模来看，2024 年全球销售额TOP40 的抗体药品种市场规模合计超过 2100 亿美元。在全球医药研发管线中，单克隆抗体药物凭借其特异性高、靶向性强和毒副作用低等特点，备受科研院所、制药企业和证券市场的青睐，成为最热门的攻关领域之一。自 21 世纪以来，单抗类药物的增长速度超过了小分子化学药，逐渐成为医药市场中发展迅猛的板块。在新药审批方面，FDA 的审批速度在近年来明显加快。2021 - 2025 年上半年，FDA 先后批准了 10 款、11 款、13 款、13 款和 7 款单克隆抗体新药，涉及抗体偶联药物（ADC）、免疫检查点抑制剂等多种类型。这些新药的获批，不仅为患者带来了更多的治疗选择，也推动了抗体药市场的进一步发展。其中，CD3 靶点在抗体药研发中表现尤为亮眼。以急性淋巴细胞白血病（ALL）等血液系统恶性肿瘤治疗为例，靶向 CD3 靶点的药物展现出了较高的特异性和更优异的疗效。通过激活或调节 T 细胞的免疫功能，这类药物能够更精准地识别和杀伤肿瘤细胞，为血液肿瘤患者带来了新的希望。在全球抗体药市场格局中，罗氏的 “三驾马车”—— 贝伐珠单抗、曲妥珠单抗和利妥昔单抗，长期占据着重要地位。然而，随着中国生物类似药的崛起，这一格局正在发生变化。中国企业通过技术创新和工艺优化，成功推出了多款质量和疗效与原研药相似的生物类似药。这些生物类似药凭借其价格优势和本土化的服务，逐渐在国内市场乃至全球市场中获得了一定的份额，对罗氏等国际药企的市场地位构成了挑战。技术迭代也在加速推动抗体药市场的变革。ADC 药物将抗体的靶向性与细胞毒性药物相结合，能够更有效地杀伤肿瘤细胞，同时减少对正常细胞的损伤，在乳腺癌、肺癌等多种癌症治疗中展现出了显著的疗效。双抗平台则通过同时靶向两个不同的抗原，实现了协同治疗的效果，为肿瘤免疫治疗等领域带来了新的突破。在肿瘤免疫治疗中，双抗药物可以同时激活免疫系统的多个环节，增强免疫细胞对肿瘤细胞的识别和杀伤能力，为癌症患者提供了更有效的治疗手段。这些新技术的出现，不仅丰富了抗体药的种类，也为患者带来了更好的治疗效果和生存质量。二、追赶走向并肩在全球抗体药市场蓬勃发展的背景下，中国国产抗体新药也迎来了爆发式增长，实现了从跟跑到并跑的跨越。自 1999 年武汉生物研究所研发的国产首款单克隆抗体生物制剂获批上市以来，中国抗体药研发不断取得突破。截至 2025 年上半年，NMPA 合计获批约 54 款 1 类抗体新药（不含生物类似药、抗体融合蛋白药、CAR-T 疗法等）。2021 - 2025 年上半年，中国获批上市的国产 1 类抗体新药达到 42 款，这一数据彰显了中国抗体药研发的强劲实力。 2025 年上半年，恒瑞医药的瑞卡西单抗获批用于高胆固醇血症的治疗。瑞卡西单抗是一种针对 PCSK9 靶点的单克隆抗体，通过抑制 PCSK9 蛋白与低密度脂蛋白受体（LDL-R）的结合，增加 LDL-R 的数量，从而降低血液中的低密度脂蛋白胆固醇（LDL-C）水平，为心血管疾病的预防和治疗提供了新的有效手段。百济神州的泽尼达妥单抗则获批用于胆道癌的治疗，泽尼达妥单抗能够特异性地结合 HER2 靶点，阻断 HER2 信号通路的激活，抑制肿瘤细胞的增殖和存活，为胆道癌患者带来了新的治疗希望。在适应症方面，国产抗体新药展现出了差异化的优势。神州细胞的菲诺利单抗获批用于头颈部鳞状细胞癌的治疗，填补了国内一线头颈部鳞状细胞癌全人群缺乏正式获批免疫治疗药物的空白。菲诺利单抗是一种重组人源化抗 PD-1 IgG4 型单克隆抗体注射液，可通过阻断 PD-1 与其配体的结合，恢复和提高 T 细胞的免疫杀伤功能，从而抑制肿瘤的生长。信达生物的替妥尤单抗 N01 获批用于甲状腺眼病的治疗，这是中国甲状腺眼病治疗领域 70 年来的首款新药，也是中国首个、全球第二款获批的 IGF-1R 抗体药物。替妥尤单抗可阻断 IGF-1 等相关配体或激动型抗体介导的 IGF-1R 信号通路激活，减轻炎症反应，改善突眼、复视、眼部充血水肿等症状和体征。国产抗体新药的研发效率也实现了飞跃。2024 年，NMPA 共批准了 13 款 1 类抗体新药，与 FDA 批准的数量基本持平。这表明中国在抗体药研发的速度和质量上已经达到了国际先进水平，能够与国际药企在同一赛道上竞争。国内药企在临床试验设计、患者招募、数据监测等方面不断优化流程，提高了研发效率。一些药企还积极与国际知名科研机构和药企开展合作，借鉴国际先进经验，加速新药研发进程。三、集采浪潮下的市场博弈随着生物医药市场的发展，集采政策已成为影响市场格局的重要因素。2025 年，安徽省医药集中采购平台发布通知，拟对阿达木单抗、贝伐珠单抗等 8 款单抗类生物制剂开展信息填报收集工作，这标志着新一轮生物药集采已提上日程。这 8 款产品的生物药及生物类似药获批企业数量均≥3 家，涉及近 300 亿的大市场，共有约 30 家国内外企业符合此次集采品种报量条件。贝伐珠单抗作为一种抑制血管内皮生长因子 (VEGF) 的抗肿瘤药物，可用于治疗直肠癌、非小细胞肺癌等多种癌症，2024 年在中国公立医疗机构终端销售额突破 100 亿元，市场规模巨大。目前，除原研药企罗氏外，国内还有齐鲁制药、信达生物、正大天晴药业、恒瑞医药等 12 家本土药企拥有生产批文，是此次集采竞争最激烈的品种之一。众多企业的参与，必然导致激烈的价格竞争，产品价格有望进一步降低，从而减轻患者的用药负担。集采后，市场份额可能会向具有成本优势、质量可靠和产能充足的企业集中，促使企业优化生产流程，提高生产效率，降低生产成本。利妥昔单抗由罗氏开发，在国内已上市的生物类似药增加至 5 款，涉及上海复宏汉霖生物制药、信达生物等药企。2024 年，利妥昔单抗在中国公立医疗机构终端销售额超 47 亿元，2025Q1 继续保持增长。上海复宏汉霖生物制药、信达生物的市场份额均已反超罗氏。集采的到来，将进一步加剧市场竞争，原研药和生物类似药之间的价格差距可能会进一步缩小，市场份额也将重新分配。这将促使企业加强市场推广和销售渠道建设，提高产品的市场覆盖率和竞争力。曲妥珠单抗用于治疗 HER2 阳性的转移性乳腺癌，国内除原研药企罗氏外，还有 5 家企业的曲妥珠单抗生物类似药获批上市。2017 年，曲妥珠单抗经谈判降价 70% 纳入国家医保乙类药目录，随后产品市场快速放量，2024 年在中国公立医疗机构终端销售额超 70 亿元，2025Q1 保持增长，罗氏、上海复宏汉霖生物市场份额遥遥领先。随着更多生物类似药的登场和集采的实施，曲妥珠单抗市场格局将迎来洗牌，企业需要不断提升产品质量和服务水平，以在市场竞争中占据优势。对于 1 类新药是否会被集采，目前仍存在诸多猜想。从政策导向来看，国家一直鼓励创新药的研发和发展，1 类新药作为创新药的代表，是企业投入大量研发资源和资金的成果，其研发过程漫长且风险高。若对 1 类新药进行集采，可能会影响企业的研发积极性和创新动力。在当前鼓励创新的大环境下，1类新药有可能会得到一定程度的豁免，以保障企业的创新回报，促进生物医药行业的创新发展。但具体情况还需关注后续政策的出台和调整。四、本土药企战略布局在全球抗体药市场的激烈竞争中，本土药企纷纷制定了创新与仿制的双轨战略，以应对市场的挑战和机遇。恒瑞医药作为国内医药行业的领军企业，采取了全面而稳健的双轨战略。在创新药研发方面，恒瑞医药持续加大投入，目前有 9 款在研抗体药处于不同研发阶段，涵盖了肿瘤、自身免疫、代谢疾病等多个领域。这些在研项目聚焦于前沿靶点和创新技术，如针对肿瘤免疫治疗的双特异性抗体，有望为患者提供更有效的治疗方案。在集采应对方面，恒瑞医药有 4 款抗体药已进入集采名单，包括贝伐珠单抗、曲妥珠单抗等。对于这些集采品种，恒瑞医药通过优化生产工艺、降低生产成本、加强质量控制等措施，提高产品的性价比，以在集采中获得优势。同时，积极拓展销售渠道，加强与医疗机构的合作，确保产品的市场覆盖和销售。正大天晴在创新与仿制的双轨战略上也有着清晰的布局。在创新药研发领域，正大天晴聚焦于肿瘤、肝病、呼吸等疾病领域，积极开展新药研发。公司拥有多个处于不同研发阶段的创新抗体药项目，如靶向 FGFR2b 的人源化单克隆抗体 TQB2210 注射液，全球范围内尚无同靶点药物上市，展现了公司在创新药研发上的领先地位。正大天晴有多个抗体类生物类似药获批上市，如贝伐珠单抗、利妥昔单抗等生物类似药。对于这些集采品种，公司凭借其完善的生产体系和质量控制体系，保障产品的质量和供应稳定性，通过成本控制和市场策略优化，提高产品的市场竞争力。正大天晴还积极储备 ADC 平台技术等前沿技术，为未来的创新药研发奠定基础。百济神州则以全球化为核心，实施创新与国际化的双轨战略。在创新药研发方面，百济神州专注于肿瘤治疗领域，其研发的泽尼达妥单抗在胆道癌治疗领域展现出显著疗效，并实现了中美双报。这一策略不仅使百济神州能够规避国内市场的激烈竞争，还能进入国际市场，获取更广阔的发展空间。通过与国际药企的合作，百济神州还获得了先进的技术和研发资源，进一步提升了自身的创新能力。在国际市场上，百济神州积极拓展销售渠道，加强品牌建设，提高产品的市场占有率。本土药企在创新药研发和集采应对方面的双轨战略，是根据自身实力和市场需求做出的明智选择。通过不断创新和优化产品结构，本土药企有望在全球抗体药市场中占据更重要的地位，为患者提供更多优质的治疗选择。最后当42款国产新药点亮中国创新药的星空，8大品种集采的硝烟也在弥漫——这场冰与火的碰撞，恰恰折射出中国医药产业的成熟蜕变：头部药企不再困守"仿制降价"的生存游戏，而是用原创靶点争夺全球话语权。恒瑞、百济们用临床价值证明，真正的护城河从来不是集采中标价，而是FDA审评通道里越来越多的"中国方案"。但挑战仍在：如何让百亿研发投入不被价格战吞噬？答案或许藏在双轨战略中：用仿制输血创新，以创新赢未来。立即扫码加入药事纵横交流群

抗体药物偶联物免疫疗法生物类似药

2025-08-13

·药明康德

首次！肿瘤完全消失半年，创新疗法亮眼结果公布；减少体重反弹还降血脂！小分子积极试验结果公布

首次！肿瘤完全消失半年，创新疗法亮眼结果公布 ImmunityBio今日公布其QUILT-106临床1期试验的初步积极结果。该研究旨在评估CD19 CAR-NK（CD19 t-haNK）自然杀伤细胞疗法单药，或与利妥昔单抗（rituximab）联合，在复发或难治性（R/R）CD19⁺CD20⁺ B细胞非霍奇金淋巴瘤（NHL）患者中的安全性及初步疗效。试验数据显示，在首两例接受治疗的晚期华氏巨球蛋白血症（WM）患者中均观察到完全缓解。WM是一种NHL，目前尚无现有疗法能够治愈。分析结果显示，一名接受单药CD19 CAR-NK细胞疗法的三线治疗患者达到完全缓解；另一名接受联合利妥昔单抗治疗的患者已维持完全缓解六个月。目前，第三名WM患者已入组接受治疗。根据新闻稿，这是首个在晚期WM患者中展示化疗方案之外免疫疗法可实现完全缓解潜力的研究。减少体重反弹还降血脂！小分子积极试验结果公布今日，Response Pharmaceuticals宣布，其在接受GLP-1受体激动剂减重治疗完成后的患者中开展的临床2期试验取得积极结果。这项双盲、安慰剂对照研究共纳入68名受试者，旨在评估RDX-002单药在曾接受GLP-1减重疗法人群中的安全性、疗效及代谢影响。RDX-002是一种在研的肠道微粒体甘油三酯转运蛋白（iMTP）选择性小分子抑制剂，iMTP是参与肠道膳食甘油三酯和胆固醇吸收的关键伴侣蛋白。分析显示，试验达主要终点，与安慰剂相比，RDX-002在12周治疗后可在统计学上显著降低患者餐后血脂水平达51.9%，并减少体重反弹幅度34%，同时改善多项心脏代谢风险指标。此外，研究中RDX-002的安全性与耐受性良好，无严重不良事件（SAE）或因不良事件（AE）导致的停药，这与以往研究结果一致。参考资料： [1] ImmunityBio Reports Complete Responses in Non-Hodgkin Waldenstrom Lymphoma Patients with Chemotherapy-Free, First-In-Class CD19 CAR-NK Immunotherapy. Retrieved August 13, 2025 from https://www.businesswire.com/news/home/20250813610481/en/ImmunityBio-Reports-Complete-Responses-in-Non-Hodgkin-Waldenstrom-Lymphoma-Patients-with-Chemotherapy-Free-First-In-Class-CD19-CAR-NK-Immunotherapy [2] Response Pharmaceuticals Announces Positive Top-Line Results From Phase 2 Study of RDX-002 in Post-GLP-1 Management. Retrieved August 13, 2025 from https://www.businesswire.com/news/home/20250813869741/en/Response-Pharmaceuticals-Announces-Positive-Top-Line-Results-From-Phase-2-Study-of-RDX-002-in-Post-GLP-1-Management 免责声明：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

细胞疗法免疫疗法临床结果临床2期

2025-08-13

·PipelineReview

ImmunityBio Reports Complete Responses in Non-Hodgkin Waldenstrom Lymphoma Patients with Chemotherapy-Free, First-In-Class CD19 CAR-NK Immunotherapy

CULVER CITY, CA, USA I Augus 13, 2025 I ImmunityBio ( NASDAQ: IBRX ), a leading immunotherapy company, announced today early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia (WM)—a type of non-Hodgkins lymphoma (NHL)—using its CD19 CAR-NK (CD19 t-haNK) natural killer cell therapy. QUILT-106 (NCT06334991) is a first-in-human trial evaluating the safety and preliminary efficacy of CD19 CAR-NK cell therapy alone and in combination with rituximab in patients with relapsed or refractory (R/R) CD19⁺CD20⁺ B-cell NHL. The disease remains challenging to treat, and WM is considered incurable with existing treatment options, making novel immunotherapies an important avenue of exploration for potential effective treatments. In the first two evaluable patients with WM who were heavily pretreated, an entirely chemotherapy-free, immunotherapy regimen induced encouraging responses. Both patients tolerated the regimen with no significant toxicities. Notably, all infusions (including CAR-NK cells and cytokines) were administered in an outpatient setting. One patient achieved a complete response (CR) with CD19 CAR NK monotherapy, while the second patient achieved CR with CD19 CAR-NK in combination with rituximab. Remission was maintained and is ongoing for six months to date. The open-label study sponsored by ImmunityBio and led by Dr. Glenda Gray, former President and CEO of the South African Medical Research Council (SAMRC) and current Chair of the Global Antibiotic Research and Development Partnership (GARDP), has enrolled 13 patients with NHL at three sites in South Africa. Of the patients enrolled so far, three have WM. Eligible study participants express CD19 and CD20, with active disease after ≥2 chemotherapy-based lines of treatment. All patients receive a lead-in cycle of CD19 CAR-NK cell monotherapy, followed by a 1-week safety observation pause, then a second cycle combining CD19 CAR-NK with rituximab. Key endpoints include safety/tolerability and objective response rate (ORR) by standard criteria. “The preliminary findings we have submitted for presentation at the American Society of Hematology annual meeting provides the first evidence that novel immunotherapy combinations without chemotherapy lymphodepletion can provide deep and durable remissions in WM even after multiple prior treatments,” said Dr. Jackie Thomson, Wits University Donald Gordan Medical Center, Johannesburg, South Africa and the lead author of the paper. “Recruitment in this rare subset of lymphoma is ongoing to confirm these findings and to establish this chemo-free strategy as a viable treatment option for relapsed WM.” ImmunityBio’s CD19 CAR-NK Therapy CD19 CAR-NK is a targeted high-affinity natural killer cell therapy – an off-the-shelf, allogeneic NK cell line engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This design enables dual anti-tumor mechanisms: direct CAR-mediated cytotoxicity and augmented antibody-dependent cellular cytotoxicity when paired with anti-CD20 monoclonal antibody rituximab. Combining CD19 CAR-NK cells with rituximab could thereby target CD19⁺/CD20⁺ lymphoma cells to enhance tumor cell killing. About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . SOURCE: ImmunityBio

免疫疗法临床结果细胞疗法临床1期ASH会议

100 项与利妥昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02994	利妥昔单抗	L01XC02	DB00073

研发状态

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适应症	国家/地区	公司	日期
心脏移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
肝移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
肺移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
胰腺移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
肾移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
小肠移植排斥	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
狼疮性肾炎	日本	Zenyaku Kogyo Co., Ltd.	2023-08-23
视神经脊髓炎	日本	Zenyaku Kogyo Co., Ltd.	2022-06-20
巴西天疱疮	日本	Zenyaku Kogyo Co., Ltd.	2021-12-24
家族性寻常型天疱疮	日本	Zenyaku Kogyo Co., Ltd.	2021-12-24
获得性血栓性血小板减少性紫癜	日本	Zenyaku Kogyo Co., Ltd.	2020-02-21
CD20阳性B细胞慢性淋巴细胞白血病	日本	Zenyaku Kogyo Co., Ltd.	2019-03-26
淋巴细胞白血病	日本	Genentech, Inc.	2019-03-26
淋巴细胞白血病	日本	IDEC Pharmaceuticals Corp.	2019-03-26
慢性特发性血小板减少性紫癜	日本	Zenyaku Kogyo Co., Ltd.	2017-06-26
血小板减少性紫癜	日本	Genentech, Inc.	2017-06-26
血小板减少性紫癜	日本	IDEC Pharmaceuticals Corp.	2017-06-26
肾病综合征	日本	Zenyaku Kogyo Co., Ltd.	2014-08-29
肾病综合征	日本	Genentech, Inc.	2014-08-29
肾病综合征	日本	IDEC Pharmaceuticals Corp.	2014-08-29

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适应症	最高研发状态	国家/地区	公司	日期
难治性 3a 级滤泡性淋巴瘤	临床3期	美国	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	中国	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	日本	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	澳大利亚	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	比利时	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	保加利亚	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	加拿大	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	克罗地亚	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	捷克	Genmab A/S	2024-02-05
难治性 3a 级滤泡性淋巴瘤	临床3期	丹麦	Genmab A/S	2024-02-05

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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


NCT00923013 (CTgov)	临床2期	毛细胞白血病	175	Cladribine+Rituximab (Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab)	醖衊壓網觸膚選築廠顧 = 蓋簾憲顧憲蓋鏇襯糧齋繭餘獵膚襯選醖壓網衊 (觸積簾餘願築範積夢鬱, 膚積鹽衊顧觸憲襯醖膚 ~ 夢鹹製鹽構積艱窪願餘) 更多	-	2025-08-08
				Cladribine+Rituximab (Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab)	醖衊壓網觸膚選築廠顧 = 艱淵窪夢繭網鏇觸鏇觸繭餘獵膚襯選醖壓網衊 (觸積簾餘願築範積夢鬱, 糧鹹鏇觸鬱襯衊糧獵膚 ~ 夢築製鏇糧鬱網構齋鏇) 更多
NCT02807103 (Pubmed \| Ann Intern Med)	临床3期	Churg-Strauss综合征	105	Glucocorticoids plus rituximab	夢簾鹹襯齋艱積網網鬱(襯願艱繭蓋壓築蓋襯構): RR = 1.05 (95.0% CI, 0.78 ~ 1.42), P-Value = 0.75 更多	不佳	2025-07-29
				Glucocorticoids alone or in combination with cyclophosphamide in severe forms
NCT02911142 (CTgov)	临床1/2期	原发性渗出性淋巴瘤	17	Lenalidomide+EPOCH+etoposide+cyclophosphamide+etoposide phosphate+prednisone+doxorubicin+Vincristine+rituximab (DA-EPOCH-R) (All Participants)	艱襯選鏇築齋築憲顧願 = 壓鹽築醖醖憲構築衊鹽膚鹽積網廠範廠積淵夢 (鑰襯製廠選襯觸願蓋衊, 獵顧衊餘齋選淵顧艱蓋 ~ 鏇選鹽獵衊構網網遞積) 更多	-	2025-07-28
				Lenalidomide+Cyclophosphamide+Etoposide Phosphate+Prednisone+Doxorubicin+Rituximab+Vincristine (Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab)	選築構顧壓遞簾餘顧繭(艱遞獵艱範窪願窪鏇齋) = 淵窪窪餘蓋齋鹽願鏇夢艱製獵鬱憲鏇淵願鏇鑰 (淵製齋選觸襯襯繭餘選, 築夢繭構餘鑰艱襯遞蓋 ~ 獵醖鹹衊蓋憲窪製鑰壓) 更多
NCT00878254 (CTgov)	临床2期	套细胞淋巴瘤	25	G-CSF+Mesna+Etoposide+Cyclophosphamide+Leucovorin+Doxorubicin+ifosfamide+Methotrexate+Rituximab+Vincristine+Cytarabine	鹹襯廠製繭選選齋鑰醖(繭糧鹹觸齋顧範廠鹹鏇) = 繭觸鏇糧觸糧醖簾顧鬱膚夢願遞鑰蓋鏇觸築鬱 (淵觸獵襯衊選築襯衊醖, 網醖襯廠齋鏇選鏇憲醖 ~ 願繭網糧顧蓋廠鏇顧鬱) 更多	-	2025-07-23
NCT00001379 (CTgov)	临床2期	淋巴瘤样肉芽肿病	94	interferon+etoposide+cyclophosphamide+prednisone+doxorubicin+vincristine+rituximab (EPOCH-R) (Participants Treated With Initial Interferon Therapy)	壓構繭鏇糧觸築遞築簾 = 壓繭顧鹽醖壓夢憲選簾餘遞憲醖鬱築齋鹹選齋 (襯餘範鹽遞壓艱齋獵鏇, 艱遞製簾簾構願壓積鬱 ~ 範鑰選廠衊憲憲醖夢膚) 更多	-	2025-06-19
				Etoposide+Cyclophosphamide+Prednisone+Doxorubicin+Rituximab+Vincristine (Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy)	壓構繭鏇糧觸築遞築簾 = 艱齋憲艱窪鬱糧蓋築選餘遞憲醖鬱築齋鹹選齋 (襯餘範鹽遞壓艱齋獵鏇, 淵積鬱網範製鬱製願鹽 ~ 鑰憲艱遞鑰衊顧蓋餘鑰) 更多
NCT05168475 (BIOVAS, CTgov)	临床2期	过敏性紫癜 \| 原发性中枢神经系统血管炎 \| 大动脉炎 ... 更多	22	Tocilizumab+Rituximab (Infliximab)	糧壓窪鏇顧壓齋醖憲廠 = 鏇醖艱衊夢網範鏇製築醖簾廠鑰願餘衊遞願窪 (淵鏇築網觸繭製膚鏇選, 鏇繭衊觸簾鏇遞顧糧觸 ~ 襯鹽艱襯選糧窪鹽選網) 更多	-	2025-06-17
				Infliximab+Tocilizumab (Rituximab)	糧壓窪鏇顧壓齋醖憲廠 = 淵願鹽鹹艱獵網齋鏇夢醖簾廠鑰願餘衊遞願窪 (淵鏇築網觸繭製膚鏇選, 選膚鬱鏇憲鹹糧鹽餘糧 ~ 願餘構壓襯襯築觸鏇廠) 更多
NCT04182204 (POLARGO, EHA2025) 人工标引	临床3期	难治性弥漫性大 B 细胞淋巴瘤	255	Pola-R-GemOx	夢衊鏇餘醖觸淵簾醖顧(廠簾鏇憲夢襯鹹艱齋鏇) = 積鹹艱糧觸餘鹽憲遞襯願壓構醖選製憲鏇鏇淵 (壓淵鑰齋製顧膚顧願築, 13.3 ~ NE) 更多	积极	2025-06-13
				R-GemOx	夢衊鏇餘醖觸淵簾醖顧(廠簾鏇憲夢襯鹹艱齋鏇) = 築鏇鏇範鏇繭範鹽願醖願壓構醖選製憲鏇鏇淵 (壓淵鑰齋製顧膚顧願築, 8.9 ~ 15.8) 更多
NCT03863184 (CTgov)	临床2期	套细胞淋巴瘤	37	Lenalidomide+Acalabrutinib+Rituximab (ALR in Combination)	簾齋鹽夢遞遞獵齋鹹蓋 = 淵繭醖鏇積齋鑰艱網窪鑰糧憲獵糧淵廠壓選衊 (簾範餘憲夢獵遞鏇艱選, 獵觸襯壓鏇願範膚顧範 ~ 餘憲築夢鬱膚廠築糧醖)	-	2025-06-06
				Lenalidomide+Acalabrutinib+Obinutuzumab (ALO in Combination)	簾齋鹽夢遞遞獵齋鹹蓋 = 鑰壓蓋衊艱選壓鏇願構鑰糧憲獵糧淵廠壓選衊 (簾範餘憲夢獵遞鏇艱選, 壓憲艱獵膚製鹽憲糧觸 ~ 獵鑰蓋壓糧齋積網餘淵)
NCT02005471 (MURANO, Pubmed \| Blood)	临床3期	复发性慢性淋巴细胞白血病	-	Venetoclax-rituximab (VenR)	顧窪壓鹽築夢築積構蓋(鬱選獵製積網鬱網夢積) = 製衊廠夢膚襯鏇遞蓋衊範淵鹹鬱願遞膚築衊觸 (夢衊積構夢遞獵憲醖憲 ) 更多	积极	2025-06-05
				Bendamustine-rituximab (BR)	顧窪壓鹽築夢築積構蓋(鬱選獵製積網鬱網夢積) = 獵壓範簾糧壓蓋餘窪窪範淵鹹鬱願遞膚築衊觸 (夢衊積構夢遞獵憲醖憲 ) 更多
NCT02356159 (CTgov)	临床1/2期	霍奇金淋巴瘤 \| 多发性骨髓瘤 \| 急性白血病 ... 更多	34	Epinephrine+PET+Acetaminophen+prednisone+EPOCH-F+Palifermin+Diphenhydramine+Rituximab (2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose)	簾築艱顧築鬱鏇繭選顧 = 鏇壓窪範窪顧鹽膚願獵製窪壓範齋製觸廠遞範 (範淵製製廠齋廠顧築鬱, 繭觸衊鬱製構壓築衊餘 ~ 鹽鹽選構淵鬱齋鏇積繭)	-	2025-06-05
				Epinephrine+PET+Acetaminophen+prednisone+EPOCH-F+Palifermin+Diphenhydramine+Rituximab (1/Phase 1: Dose Escalation Arm - Palifermin)	簾遞夢淵夢積廠餘範廠 = 糧衊糧齋糧憲膚鹹淵鹽製窪鑰壓鏇築夢網遞壓 (觸觸糧膚繭觸簾願構糧, 遞構範積齋鹽築夢觸願 ~ 膚範顧觸蓋鑰構積餘製)