格菲妥单抗(Glofitamab) - 药物靶点：CD20 x CD3_在研适应症：复发性弥漫性大B细胞淋巴瘤，难治性弥漫性大 B 细胞淋巴瘤，弥漫性大B细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

双特异性T细胞结合器

别名

Anti-CD20/CD3 bispecific monoclonal antibody、Anti-CD20/CD3 bispecific monoclonal antibody RO7082859、Glofitamab (USAN/INN)

+ [14]

靶点

CD20 x CD3

作用方式

抑制剂、刺激剂

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、CD3刺激剂(T细胞表面糖蛋白CD3复合体刺激剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [4]

在研适应症

复发性弥漫性大B细胞淋巴瘤难治性弥漫性大 B 细胞淋巴瘤弥漫性大B细胞淋巴瘤+ [28]

非在研适应症

CD20阳性B细胞淋巴瘤

原研机构

F. Hoffmann-La Roche Ltd.

在研机构

F. Hoffmann-La Roche Ltd.

Genentech, Inc.Hoffmann-La Roche, Inc.

+ [10]

非在研机构-

权益机构

Biogen, Inc.

Genentech, Inc.

最高研发阶段批准上市

首次获批日期

加拿大 (2023-03-24),

弥漫性大B细胞淋巴瘤滤泡性淋巴瘤高级别B细胞淋巴瘤+ [1]

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (澳大利亚)、附条件批准 (欧盟)、突破性疗法 (中国)、优先审评 (美国)、附条件批准 (中国)、附条件批准 (加拿大)、优先审评 (中国)

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结构/序列

Sequence Code 10044005

来源: *****

Sequence Code 10044025

来源: *****

Sequence Code 616723731

来源: *****

Sequence Code 616723732

来源: *****

关联

113

项与格菲妥单抗相关的临床试验

NCT07649304

/ Recruiting临床1期IIT

A Feasibility Study of Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma

This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time. This may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. 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. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. 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. Giving glofitamab in combination with the R-CHOP regimen may be a safe treatment for patients with newly-diagnosed with HIV-associated large B-cell lymphoma.

开始日期2027-07-05

申办/合作机构

National Cancer Institute

NCT07634289

/ Not yet recruiting临床2期IIT

Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma: The Phase II Radio-GLO Study

The goal of this clinical trial is to see if a new combination of standard of care radiotherapy treatment prior to administering the study drugs obinutuzumab and glofitamab in relapsed/refractory Diffuse Large B Cell Lymphoma patients is effective. The main question it aims to answer is:
If you are able to tolerate the study treatments, and whether your cancer responds to the study treatment, compared with other reported studies of standard care treatments.
Participants will have three parts they need to complete over a 5 year period.
* Screening period over a 28 day period
* Treatment period - Radiotherapy followed by 12 treatment cycles every three weeks (total time approx. 37 weeks)
* Follow up, up to 4 years. Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and 18F-Granzyme B for evaluation of the impact of radiotherapy plus glofitamab with relapsed diffuse large B-cell lymphoma.

开始日期2026-12-01

申办/合作机构

Olivia Newton-John Cancer Research Institute

[+5]

NCT07502872

/ Not yet recruiting临床2期IIT

TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).

开始日期2026-11-01

申办/合作机构

Brown University

[+3]

100 项与格菲妥单抗相关的临床结果

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100 项与格菲妥单抗相关的转化医学

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100 项与格菲妥单抗相关的专利（医药）

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161

项与格菲妥单抗相关的文献（医药）

2026-11-01·HEMATOLOGICAL ONCOLOGY

Peripheral CD4 ⁺ T‐Cell Reserve as a Potential Biomarker of CD20 × CD3 Bispecific Antibody Outcomes and BTK Inhibitor–Associated Immune Modulation in B‐Cell Lymphoma

Article

作者: Chen, Jie ; Zhang, Wenhui ; Chai, Jin ; Song, Yuqin ; Li, Yanxiang ; Zhu, Jun ; Cao, Jiaowu ; Yu, Hui ; Jin, Zhao ; Lv, Jie ; Hu, Dingyao ; Wang, Yue

ABSTRACT:

Bispecific antibodies (BsAbs) targeting CD20 × CD3 have achieved remarkable efficacy in relapsed or refractory (R/R) B‐cell lymphoma, yet clinical responses remain heterogeneous and predictive biomarkers are lacking. We retrospectively evaluated associations between peripheral immune profiles and outcomes in 40 patients treated with CD20 × CD3 BsAbs and explored BTK inhibitor–associated immune changes using a paired BTK inhibitor cohort, functional assays, mouse models, and single‐cell RNA sequencing. Higher baseline CD4 + T‐cell counts correlated with superior response rates and prolonged progression‐free survival, whereas CD8 + counts showed no association. Elevated CD4 + T‐cell levels were linked to increased activation of effector CD8 + CD28 + T cells and greater induction of IL‐2 and IFN‐γ following treatment. Across paired clinical samples and experimental models, BTK inhibition was associated with CD4 + T‐cell expansion and enhanced T/NK‐cell proliferative and cytotoxic signatures. In an exploratory real‐world observation, three patients received BTK inhibition before glofitamab; all achieved complete responses, with two remaining in remission at data cutoff and one relapsing after 8.4 months. These findings identify peripheral CD4 + T‐cell reserve as a potential biomarker associated with BsAb outcomes and provide a rationale for further investigation of BTK inhibitor–mediated immune modulation in BsAb treatment strategies.

2026-11-01·HEMATOLOGICAL ONCOLOGY

Accelerated Glofitamab as Urgent Bridging to CAR T‐Cell Therapy in High‐Risk Relapsed/Refractory Large B‐Cell Lymphoma

Article

作者: Zhang, Wei ; Liu, Xiyang

ABSTRACT:

Conventional glofitamab step‐up dosing reaches the 30‐mg target dose approximately 3 weeks after obinutuzumab. This interval may be difficult to accommodate in patients with relapsed or refractory large B‐cell lymphoma (R/R LBCL) who require disease control within days before cellular therapy. We retrospectively evaluated an accelerated bridging schedule of obinutuzumab 1000 mg on day 1 followed by glofitamab 2.5 mg on day 4, 10 mg on day 8, and 30 mg on day 11. Forty‐one consecutive adults with R/R LBCL were included. All patients had a documented plan to proceed to chimeric antigen receptor (CAR) T‐cell therapy after glofitamab initiation. The cohort was high risk: 90.2% had stage III–IV disease, 70.7% had an International Prognostic Index score of 3%–5%, and 46.3% had central nervous system (CNS) involvement. Cytokine release syndrome (CRS) occurred in 8 patients (19.5%), including 1 grade 3 event; immune effector cell‐associated neurotoxicity syndrome (ICANS) occurred in 2 patients (4.9%), both grade 1–2. At the prespecified day‐12 assessment, the overall response rate was 80.5% (33/41). Among 19 patients with CNS involvement, 18 (94.7%) responded, and cerebrospinal fluid cytology cleared in all evaluable patients with baseline positivity. After one cycle, 38 of 41 patients (92.7%) proceeded to planned CAR T‐cell therapy. In this relatively small retrospective cohort, accelerated glofitamab bridging therapy showed rapid early antitumor activity and manageable toxicity, and a high response rate after subsequent CAR T‐cell therapy. Longer‐term outcomes could not be attributed to glofitamab alone. These findings are descriptive and require prospective validation.

2026-11-01·HEMATOLOGICAL ONCOLOGY

Non‐Relapse Mortality With Bispecific Antibodies in Hematologic Malignancies: A Dual Systematic Review and Pharmacovigilance Analysis

Review

作者: Singh, Sharda ; Irfan, Sohaib ; Varisco, Tyler J. ; Abid, Muhammad Bilal ; Khosla, Harshit ; Kaur, Manmeet ; Nasir, Saad ; Ononogbu, Onyebuchi

ABSTRACT:

Bispecific antibodies (BsAbs) redirect T‐cells to tumor antigens in an MHC‐independent manner. These universally available, off‐the‐shelf products have demonstrated unprecedented efficacy in heavily pretreated patients with relapsed/refractory (R/R) hematological malignancies (HMs). The indefinite treatment duration associated with most BsAb products, coupled with neutropenia, B‐cell aplasia, and hypogammaglobulinemia result in significant immune‐related toxicities and infections. Hence, non‐relapse mortality (NRM) which represents the cumulative burden of treatment‐related toxicities, defined as death from any cause other than disease relapse or progression, is a patient‐centric endpoint across cellular therapy platforms. While recent NRM estimates with CAR T‐cell therapy have identified infections as major drivers of NRM, real‐world NRM estimates remain limited with BsAbs. To mitigate the limitations associated with each of the methods, we conducted a systematic review and meta‐analysis of the existing literature, supplemented concurrently by a pharmacovigilance analysis using the FAERS database, to estimate NRM with BsAbs and compare real‐world findings between commercially available BsAb products approved for relapsed/refractory multiple myeloma (RRMM) and NHL. The primary endpoint was NRM; secondary endpoints included CRS, ICANS, infections, and death. Teclistamab demonstrated a high toxicity burden across both analytic methods, with the highest ICANS incidences, significantly greater infection rates (particularly grade > 3), and a non‐negligible NRM estimate in the SRMA as well in FAERS. Glofitamab was associated with severe toxicities, including increased reporting odds for NRM and overall mortality. Mosunetuzumab showed lower pooled estimates and lower reporting odds, as seen in both analytic approaches. Low pooled incidences of infections, and ICANS were calculated in the SRMA. FAERS analyses also suggested reduced reporting odds for NRM and neurotoxicity. While trial‐level data and real‐world reporting largely converged for severe toxicities, divergences in other agents underscore the importance of continuous post‐marketing surveillance. Given the risks associated with prolonged treatment, future protocols must prioritize infection management and adopt NRM as a standardized endpoint to guide appropriate therapeutic selection and sequencing.

1,027

项与格菲妥单抗相关的新闻（医药）

2026-10-28

·六日行研社

【药闻速递2026.10.28】科伦博泰/默沙东sac-TMT美国BLA获优先审评；恒瑞HER3 ADC登《柳叶刀》，NDA已受理冲刺全球首个

❈ ❈ ❈ ❈ ” 国内新闻 ❀ 恒瑞公布III期HERON-Lung01并同步登《柳叶刀》：瑞康芦泽妥塔单抗（SHR-A2009，HER3 ADC）治疗EGFR-TKI经治EGFR突变非鳞NSCLC（498例），mPFS 8.3 vs 含铂化疗5.4个月（HR 0.47，p<0.0001），ORR60.0% vs 34.3%，ILD仅2.4%；国内报产已受理，另获美国FDA快速通道资格。点评：HER3曾是ADC"折戟地"——默沙东/第一三共patritumab deruxtecan III期PFS仅延长0.4个月、OS未达而撤回申请，恒瑞以DAR=4中等载药+全人源抗体的差异化设计将PFS绝对获益拉大到近3个月，成为全球首个成功的HER3 ADC III期，7月国内报产后有望率先撞线"全球首个HER3 ADC"。EGFR-TKI耐药后线是三代TKI存量市场的"接棒"场景，商业空间明确；OS趋势HR 0.70且近20%患者交叉用药，最终OS成熟后证据更硬。风险在于T-DXd、Dato-DXd在相似人群的跨线竞争，以及ILD的长期监测。 ❀ 艾伯维宣布CD3×CD20双抗艾可瑞妥单抗（艾可来）正式在华商业上市，联合来那度胺与利妥昔单抗治疗复发/难治滤泡性淋巴瘤成人患者；皮下注射单次约5分钟，适应症曾获NMPA优先审评，已纳入CSCO 2026淋巴瘤诊疗指南。点评：惰性淋巴瘤复发人群庞大、院外管理属性强，皮下双抗"门诊5分钟给药"天然适配DTP药房与双通道渠道，是细胞免疫治疗"去住院化"的代表性落地。epcoritamab在欧美一线DLBCL III期PFS已达标（进展风险降51%），国内先卡位复发难治、再向前线推进的路径清晰，将与罗氏格菲妥单抗正面争夺双抗市场。注意CRS管理门槛：渠道建设需绑定有血液科输注能力与双通道资质的机构。对国内药企而言，血液瘤TCE正从临床验证期进入商业化兑现期，康诺亚、神州细胞等玩家的定价与准入策略将参照这一标杆。 ❀ ESMO公布III期APEX-Breast01（LBA口头）：TQB2102（HER2双表位ADC）治疗HER2低表达复发/转移性乳腺癌，mPFS 16.4 vs 5.5个月（HR 0.29）；经治HER2阳性胃癌II期三药队列ORR达95.8%，后续III期推荐剂量6mg/kg。该适应症已获CDE突破性疗法认定并于9月申报上市。点评：HR 0.29是HER2低表达乳腺癌迄今最深的III期获益幅度之一，直接对标T-DXd的DESTINY-Breast04（HR 0.50）——若跨试验比较成立，双表位设计覆盖HER2两个非重叠表位可能带来更广抗原结合与更高载荷递送效率。中国生物制药22项研究入选本届ESMO，系统化产出能力仅次于头部Biotech。胃癌II期ORR 95.8%虽为小样本，但已足够支撑III期推进。商业看点在于：该品种9月已报产，若2027年获批，将与T-DXd（罗氏）、SHR-A1811（恒瑞）在HER2低表达/阳性双人群形成"三强格局"，国内定价与医保准入速度将是关键变量。国际新闻 ❀ 默沙东宣布，基于III期TroFuse-005（OS 19.0 vs 12.1个月，死亡风险降32%，同步登《柳叶刀》），芦康沙妥珠单抗治疗经治晚期子宫内膜癌的美国BLA获FDA受理并授予优先审评，PDUFA日期2027年6月15日，系该分子首个全球III期注册提交，公司称有望提前获批。点评：从ESMO主席论坛读出到FDA受理仅隔一天，sac-TMT的全球注册机器全面开动——默沙东正围绕该分子布局18项全球III期，将其定位为"K药之后"的核心接棒资产。对中国ADC出海而言，这是标志性一刻：首个由MNC主导、以OS为共同主要终点的国产ADC全球III期走向获批，PDUFA落地意味着科伦博泰的里程碑与分成现金流有了明确时间表。TroFuse-005中≥3级TRAE较对照高约13个百分点，风险管理将是标签谈判焦点。后续关注欧洲、日本递交节奏及乳腺癌、肺癌等更大适应症排队——子宫内膜癌只是sac-TMT全球版图的第一块拼图。 ❀ ESMO公布I期数据：INCB161734（RAS多选择性抑制剂）联合mFOLFIRINOX一线治疗转移性胰腺癌28例患者确认ORR81%，与Revolution zoldonrasib此前报道的82%相当；联合吉西他滨/白蛋白紫杉醇ORR 58%；一线胰腺癌全球III期已启动，顶线数据预计2028年。点评：胰腺癌一线是肿瘤治疗最后的"硬骨头"之一，现行FOLFIRINOX的mOS仅约11个月。RAS多选择性抑制剂以"靶向+化疗"嵌入一线并拿出81%的ORR，若PFS/OS转化成立，将重写一线治疗路径——对应全球每年约35万例胰腺癌新发的巨大空间。Incyte与Revolution"并驾齐驱"，一线头对头之争2028年见分晓；BMS daraxonrasib、礼来等亦在追赶。对中国药企，KRAS G12D管线（劲方GFH375已进III期、恒瑞HRS-4642围术期II期）的窗口仍在，但需以全球多中心设计与OS终点对标，避免沦为国内市场单品。 ❀ 辉瑞宣布，基于III期研究成功，已向FDA递交BCMA×CD3双抗Elrexfio（elranatamab）治疗复发/难治多发性骨髓瘤的上市申请；该药此前以加速批准获批经治人群，本次为关键III期验证后的确证性申报，将支持从加速批准转为常规批准。点评：BCMA赛道正进入"加速批准转常规+线次前移"的关键阶段：强生Teclistamab、辉瑞Elrexfio与CAR-T（Carvykti等）在复发难治骨髓瘤的排序之争，将决定百亿美元市场格局。Elrexfio以皮下给药+门诊管理对CAR-T的清淋住院形成差异化，III期成功后转常规批准有助于在社区肿瘤渠道放量。对中国而言，传奇生物的CAR-T与驯鹿、华东医药等双抗管线将面对同样的格局演化——血液瘤细胞免疫治疗的价值锚正从"缓解深度"转向"可及性与给药便利"，商业化能力而非临床数据将成为下一个分水岭。

2026-10-27

·血液日记

套细胞淋巴瘤：BTK抑制剂耐药之后，路在哪里

套细胞淋巴瘤（MCL）在非霍奇金淋巴瘤里不算高发。国内专家共识数据显示，它占国内NHL病例的1.0%~3.1%，患者发病中位年龄约60岁，男性占比更高。这个疾病比较特殊，同时有着侵袭性淋巴瘤进展快、惰性淋巴瘤难以根治的特点，很多患者一线治疗后，最终还是会面对复发。过去十年，BTK抑制剂重塑了套细胞淋巴瘤的治疗格局。共价型BTK抑制剂早已成为复发后的常规方案，不少患者可以借此把病情稳住。但它的短板也很突出：疗效持续时间有限，一旦出现耐药，后续怎么治，一直是临床里棘手的难题。耐药之后，有哪些备选方案 2025年《Haematologica》上的一篇综述直接点明：共价BTK抑制剂耐药的套细胞淋巴瘤，是尚未被充分满足的临床需求。临床上需要理清耐药机制，尽早识别出高危患者。目前已经落地或者接近临床应用的方案，主要分为三类。第一类是非共价BTK抑制剂。匹妥布替尼在国内针对BTK经治的套细胞淋巴瘤开展研究，35例受试者的客观缓解率62.9%，12个月缓解持续率59.7%。数据说明，这种结合机制不一样的BTK药物，可以帮助一部分耐药患者再次控制肿瘤，不过实现完全缓解的比例依旧不高。第二类是双特异性抗体。这类药物一端结合T细胞、一端锚定肿瘤B细胞表面的CD20，调动自身免疫细胞去攻击肿瘤。Glofitamab的I/II期NP30179研究结果显示，在多线治疗失败的复发难治MCL患者中，固定疗程单药治疗的客观缓解率85.0%，完全缓解率78.3%；其中既往用过BTK抑制剂的31例患者，完全缓解率仍有71.0%。对于BTK耐药人群来说，这个结果很有参考价值。需要说明的是，双特异性抗体目前在国内获批的是弥漫大B细胞淋巴瘤适应症，用于套细胞淋巴瘤多属于临床试验或个案探索，能否使用需由主治医生评估。第三类是CAR-T细胞治疗。符合条件的患者，CAR-T仍是优先选项之一，尤其适合BTK抑制剂耐药之后。不过这项治疗对患者体能、就诊中心的配套能力都有要求，并不是所有人都能够接受。这些新选择，改变了以往BTK耐药后几乎没有办法的局面。2026年《European Journal of Haematology》的综述提到，双抗和CAR-T属于互补的治疗手段：双抗可以作为CAR-T之前的桥接治疗，CAR-T也可以用来巩固双抗诱导出来的缓解状态。可选方案变多，不等于选择更简单，先用哪一种、后续如何序贯、身体能不能耐受，都要结合个人情况判断。复诊沟通可以重点问这几点如果自己或者家人已经出现BTK抑制剂耐药，复诊时可以和主治医生认真沟通下面几件事。首先，分清耐药的实际情况：是影像检查看到病灶进展，还是仅仅肿瘤标志物出现波动，这点直接决定什么时候启动新方案。其次，确认双特异性抗体、CAR-T当前是否方便获取。目前国内用于MCL主要依赖临床试验渠道。双抗属于现成制剂，不用等待细胞制备，对于肿瘤负荷偏高、需要快速控瘤的患者，这个优势很实际。另外，可以主动询问有没有匹配的临床试验。套细胞淋巴瘤的新药研发节奏很快，临床试验常常能提供还未上市、已有早期数据支撑的治疗方向。套细胞淋巴瘤的后线治疗，正从“BTK耐药后可选方案匮乏”，慢慢过渡到拥有多种不同作用机制的接续疗法。但治疗依旧不能一概而论，每一步方案，都要依托肿瘤特点和患者自身的身体状态来定。如果您或您的家人想要尝试新的治疗方案或者参加临床项目，不妨点击左下角“阅读原文”联系我们本文仅用于医学科普交流，不能替代临床诊疗意见，具体治疗方案请遵从主治医生安排。参考出处 [1] Grainger BT, Cheah CY. “The End of the Golden Weather”: therapeutic strategies for mantle cell lymphoma relapsed or refractory to covalent BTK inhibitors. Haematologica, 2025;110(3):576-587. DOI: 10.3324/haematol.2024.286205 . https://pubmed.ncbi.nlm.nih.gov/39540208/ [2] Liu Y, Lin N, Yi S, et al. Pirtobrutinib in Chinese patients with relapsed or refractory B-cell malignancies: a single-arm, open-label, phase 2, multicenter trial. International Journal of Cancer, 2025;156(11):2158. DOI: 10.1002/ijc.35339. https://doi.org/10.1002/ijc.35339 [3] Phillips TJ, Carlo-Stella C, Morschhauser F, et al. Glofitamab in relapsed/refractory mantle cell lymphoma: results from a phase I/II study. Journal of Clinical Oncology, 2025;43(3):318-328. DOI: 10.1200/JCO.23.02470. https://doi.org/10.1200/JCO.23.02470 [4] T-cell-redirecting immunotherapies in relapsed/refractory mantle cell lymphoma: current evidence, sequencing, and future directions. European Journal of Haematology, 2026;116(2):129-141. PMID: 41207679. https://pubmed.ncbi.nlm.nih.gov/41207679 / [5] 中华医学会血液学分会淋巴细胞疾病学组, 中国医药教育协会淋巴疾病专业委员会. 老年套细胞淋巴瘤诊断与治疗中国专家共识（2026年版）[J]. 中华血液学杂志, 2026, 47(5): 424-432. DOI: 10.3760/cma.j.cn121090-20260207-00084 .

免疫疗法细胞疗法

2026-10-24

·医药魔方ByDrug

【2476】研究精读｜最佳完全缓解率95%：双抗联合治疗为初治DLBCL带来哪些启示？

在初治弥漫大B细胞淋巴瘤（DLBCL）中，将双特异性抗体（双抗）加入免疫化疗，能否兼顾缓解深度与持续疾病控制？一项近期发表于Blood的多中心Ⅱ期研究，评估了格菲妥单抗（glofitamab）联合含维泊妥珠单抗（polatuzumab vedotin，Pola）的免疫化疗方案。研究报告，41例患者的最佳完全缓解（CR）率为95%，估计24个月无进展生存（PFS）率亦为95% 。

临床结果临床研究

100 项与格菲妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11833	-	L01FX28	DB16371

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性弥漫性大B细胞淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-25
难治性弥漫性大 B 细胞淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-25
弥漫性大B细胞淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-24
滤泡性淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-24
高级别B细胞淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-24
纵隔大b细胞淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-24

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
套细胞淋巴瘤	临床3期	美国	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	中国	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	澳大利亚	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	巴西	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	加拿大	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	法国	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	意大利	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	韩国	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	西班牙	罗氏（中国）投资有限公司	2023-10-09
套细胞淋巴瘤	临床3期	瑞典	罗氏（中国）投资有限公司	2023-10-09

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临床结果

适应症

分期

评价

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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


ASTRO2026	N/A	B细胞淋巴瘤	169	epcoritamab (High MTV (>=111 cc))	鬱積糧顧製顧鹹齋遞網(構廠觸築襯齋鬱遞夢鬱) = 積艱鹽鹽鑰齋觸遞網窪鹹衊襯鏇憲淵簾構願餘 (襯鬱蓋壓簾廠齋構顧夢 ) 更多	积极	2026-09-27
				glofitamab (High MTV (>=111 cc))	鬱積糧顧製顧鹹齋遞網(構廠觸築襯齋鬱遞夢鬱) = 顧鹽鑰築壓鹽廠壓襯夢鹹衊襯鏇憲淵簾構願餘 (襯鬱蓋壓簾廠齋構顧夢 ) 更多
NCT04980222 (Phase II open-label prospective trial, CTgov)	临床2期	弥漫性大B细胞淋巴瘤	46	Cyclophosphamide+prednisone+Tocilizumab+Doxorubicin+Glofitamab+Rituximab+Vincristine	艱憲窪願廠膚鏇艱範艱 = 夢憲衊鹽製顧顧觸遞鏇襯夢廠衊範鹽鹽襯構鬱 (鬱鏇鹹廠選簾鏇築壓鏇, 糧選膚廠觸遞製獵網壓 ~ 製衊夢醖衊願襯積鬱衊) 更多	-	2026-08-18
NCT04703686 (LYSA BiCAR, Pubmed \| J Hematol Oncol)	临床2期	弥漫性大B细胞淋巴瘤 CD20-positive	47	Glofitamab (CD20-positive Diffuse Large B-Cell Lymphoma + Refractory or first relapse after anti-CD19 CAR T-cell therapy)	壓鹽壓築廠廠鹹廠糧鑰(範廠襯構醖鑰繭構艱積) = 鹹窪艱觸齋網鏇範鬱廠廠遞膚衊鬱顧壓遞鑰廠 (鏇製鬱糧願衊鏇餘願窪 ) 更多	积极	2026-07-01
				Non-bispecific systemic therapy (CD20-positive Diffuse Large B-Cell Lymphoma + Refractory or first relapse after anti-CD19 CAR T-cell therapy)	壓鹽壓築廠廠鹹廠糧鑰(範廠襯構醖鑰繭構艱積) = 繭醖衊積觸襯窪鑰廠觸廠遞膚衊鬱顧壓遞鑰廠 (鏇製鬱糧願衊鏇餘願窪 )
ASCO2026	N/A	弥漫性大B细胞淋巴瘤	936	CAR T-cell therapy	簾廠觸襯淵築淵餘製夢(夢淵鏇網遞獵積範願艱) = 襯齋憲簾顧壓齋衊膚淵蓋構願網壓壓簾憲蓋鹽 (艱製糧築窪鹽膚選醖艱 ) 更多	积极	2026-05-29
				Bispecific antibodies	簾廠觸襯淵築淵餘製夢(夢淵鏇網遞獵積範願艱) = 膚窪鑰顧獵選鹹網蓋艱蓋構願網壓壓簾憲蓋鹽 (艱製糧築窪鹽膚選醖艱 ) 更多
NCT06393738 (ASCO2026)	临床1期	非霍奇金淋巴瘤 \| 弥漫性大B细胞淋巴瘤	255	ARV-393 (relapsed or refractory B-cell NHL or nTFHL)	顧簾蓋築淵網鑰製顧膚(壓願鬱製築範築願繭夢) = 蓋廠構鑰遞選夢鑰網憲淵繭齋艱網鏇憲窪網壓 (膚艱觸觸簾積鏇製醖憲 )	积极	2026-05-29
ASCO2026	N/A	B细胞淋巴瘤	63	Glofitamab	壓鹽糧憲襯築觸鹽襯構(壓糧繭遞鏇構憲窪製衊) = 築獵觸築糧衊窪鹹蓋淵衊憲廠築衊網鬱艱膚獵 (簾齋選願膚選夢觸淵獵 ) 更多	积极	2026-05-29
				Epcoritamab	壓鹽糧憲襯築觸鹽襯構(艱壓網顧衊糧醖憲繭鹹) = 衊觸蓋願艱糧膚醖鏇構鬱構鬱鏇築構遞膚構壓 (艱鬱艱築範蓋鏇願繭餘 ) 更多
ASCO2026	N/A	复发性弥漫性大B细胞淋巴瘤	410	epcoritamab	網簾襯鑰願網衊繭築選(淵構製憲憲選夢廠觸鹹) = 19.0% vs 25.4% 積鹹艱鬱繭獵憲膚淵夢 (鹽膚糧選鏇襯選範淵遞 ) 更多	积极	2026-05-29
				glofitamab
NCT03075696 (ASCO2026)	临床1/2期	套细胞淋巴瘤	60	Obinutuzumab 1000mgObinutuzumab 2000mgGlofitamab + Obinutuzumab 1000mgObinutuzumab 2000mgGlofitamabab 1000mg + Obinutuzumab 1000mgObinutuzumab 2000mgGlofitamabab 2000mg	壓衊鏇範願蓋餘積襯製(襯壓壓鹽淵鹹鹽襯製顧) = 顧夢齋繭遞壓繭遞製襯鏇鏇繭遞壓繭範糧鬱鏇 (夢蓋製齋積襯餘構艱衊 ) 更多	积极	2026-05-29
				Obinutuzumab 2000mg (prior BTKi therapy)	壓衊鏇範願蓋餘積襯製(襯壓壓鹽淵鹹鹽襯製顧) = 構壓簾淵選窪鬱餘顧壓鏇鏇繭遞壓繭範糧鬱鏇 (夢蓋製齋積襯餘構艱衊 ) 更多
ASCO2026	N/A	急性淋巴细胞白血病 \| 小细胞癌 \| B细胞淋巴瘤 ... 更多	3,642	bispecific T-cell engager therapy	鹽構構鑰築鹹獵夢夢獵(窪鹽窪憲獵糧築淵繭鏇) = 蓋糧醖簾艱願觸淵齋襯選醖積構遞製構齋願壓 (築積窪鬱鬱襯簾構觸願 ) 更多	积极	2026-05-29
NCT03075696 (EHA2026)	临床1/2期	难治性套细胞淋巴瘤	61	Glofitamab	顧鑰鏇顧窪構糧繭淵網(蓋積憲願鏇範餘壓顧遞) = Cytokine release syndrome remained the most common adverse event (all Grade, n=42/60, 70%; Grade 1-2, 58.3%; Grade 3-4, 11.6%; no Grade 5 events), with lower rates reported in the 2000mg Gpt cohort (n=28/44, 63.6%) compared with the 1000mg Gpt cohort (n=14/16, 87.5%). 築窪醖壓憲獵夢觸醖鏇 (築積網餘衊夢願夢鏇壓 )	积极	2026-05-21
				Glofitamab (received prior BTKi therapy)