达雷妥尤单抗(Daratumumab) - 药物靶点：CD38_在研适应症：阴燃多发性骨髓瘤，免疫球蛋白轻链淀粉样变性，难治性多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Daratumumab (Genetical Recombination)、达拉图单抗、达雷木单抗

+ [7]

靶点

CD38

作用方式

抑制剂

作用机制

CD38抑制剂(淋巴细胞分化抗原CD38抑制剂)、ADCC(抗体依赖的细胞毒作用)、抗体依赖的细胞吞噬作用

治疗领域

肿瘤免疫系统疾病内分泌与代谢疾病+ [7]

在研适应症

阴燃多发性骨髓瘤免疫球蛋白轻链淀粉样变性难治性多发性骨髓瘤+ [20]

非在研适应症

淋巴母细胞淋巴瘤难治性B细胞淋巴瘤结外NK-T细胞淋巴瘤+ [12]

原研机构

Janssen Global Services LLC

在研机构

AbbVie, Inc.Janssen-Cilag International NV

Genentech, Inc.

+ [17]

非在研机构-

权益机构

Genmab A/S

Janssen Biotech, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2015-11-16),

多发性骨髓瘤

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、优先审评 (日本)、孤儿药 (英国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 9075449L

来源: *****

Sequence Code 9946743H

来源: *****

关联

368

项与达雷妥尤单抗相关的临床试验

NCT07605416

/ Recruiting临床2期IIT

Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial

This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. Dexamethasone 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. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.

开始日期2027-04-20

申办/合作机构

National Cancer Institute

IRCT20230801058996N9

/ Suspended临床1/2期IIT

Safety and efficacy of combination therapy with daratumumab and activated allogeneic natural killer cells in relapsed/refractory multiple myeloma

开始日期2027-01-21

申办/合作机构

Shahid Beheshti University of Medical Sciences

NCT07221032

/ Not yet recruiting临床1期IIT

Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma

This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.

开始日期2026-10-01

申办/合作机构

Medical College of Wisconsin

100 项与达雷妥尤单抗相关的临床结果

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100 项与达雷妥尤单抗相关的转化医学

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100 项与达雷妥尤单抗相关的专利（医药）

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2,266

项与达雷妥尤单抗相关的文献（医药）

2027-01-01·CLINICA CHIMICA ACTA

M-protein detection using two immunofixation electrophoresis systems and impact of daratumumab interference on disease monitoring

Article

作者: Kushima, Saki ; Kawano, Yawara ; Nakamura, Tomofumi ; Tanaka, Yasuhito ; Mori, Daisuke ; Ishihara, Ayako ; Fukushima, Rika

M-protein identification by immunofixation electrophoresis (IFE) varies depending on equipment and reagents used. Daratumumab (DARA), an IgGκ monoclonal antibody for multiple myeloma treatment, frequently interferes with IFE interpretation. This study compared the analytical performance of two IFE systems and evaluated the impact of DARA interference on IFE interpretation. We compared the current system, Epalyzer 2 Jr. (Helena), with the target system, HYDRASYS 2 (Sebia), using 104 clinical samples including suspicious positive cases, 20 AL amyloidosis patients, and 76 other clinical cases from our hospital. For 10 DARA-treated samples, changes were evaluated before and after DARA displacement using the HYDRASHIFT Daratumumab (Sebia) assay. The concordance rate between the two systems ranged from 60.0% to 88.5%. AL amyloidosis patient samples showed the lowest agreement rate. In 20 discordant cases, HYDRASYS detected additional bands, mainly light chains, that were missed by Epalyzer. Among DARA-treated samples, concordance was observed in only one case. In the remaining nine cases, IgGκ bands detected by the current method disappeared following DARA displacement, with three cases becoming entirely negative. HYDRASYS demonstrated superior sensitivity for detecting M-proteins and free light chains compared to Epalyzer. When DARA-derived bands interfere with IFE interpretation, DARA displacement is necessary for accurate assessment of hematologic response in patients with multiple myeloma.

2026-12-31·Hematology

Temporal trends in second primary malignancies among long-term survivors of multiple myeloma across treatment eras: a population-based analysis of the SEER database

Article

作者: Chen, Yating ; Lin, Shenglan ; Lu, Liling ; Huang, Yiqun

OBJECTIVE:

To evaluate temporal trends in second primary malignancy (SPM) risk among long-term multiple myeloma (MM) survivors across treatment eras.

METHODS:

This retrospective cohort study utilized the SEER 17 registries database (1975-2022). Patients with MM as first primary malignancy surviving ≥5 years were stratified into four treatment eras: Era 1 (≤2000, pre-novel agents), Era 2 (2001-2010, proteasome inhibitor/IMiD introduction), Era 3 (2011-2015, new-generation IMiDs), and Era 4 (2016+, daratumumab era). SPM was defined as any malignancy occurring ≥5 years post-diagnosis. Cumulative incidence was estimated using competing risk analysis.

RESULTS:

Among 52,497 MM patients, 15,402 (29.34%) achieved 5-year survival. Overall, 1,408 patients (9.14%) developed SPM over 72,951.70 person-years. SPM rates declined significantly across eras: 11.43% (Era 1), 10.45% (Era 2), 7.78% (Era 3), and 2.45% (Era 4) (Ptrend < 0.001). The most common SPMs were prostate (13.81%), lung (10.17%), and breast cancer (7.42%). Acute myeloid leukemia (6.78%) remained notable among hematologic malignancies. Sensitivity analysis among 10-year survivors confirmed the declining trend.

CONCLUSIONS:

SPM rates progressively declined from Era 1 through Era 3, with encouraging early signals in Era 4 requiring longer follow-up. The shift from alkylating agents to targeted therapies may contribute to reduced SPM occurrence, providing preliminary evidence for improved long-term safety of contemporary MM treatments.

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Indirect treatment comparison of DVRd plus DR maintenance (PERSEUS study) versus DVTd or VTd with or without lenalidomide maintenance in transplant-eligible patients with previously untreated multiple myeloma

Article

作者: He, Jianming ; Nair, Sandhya ; Einsele, Hermann ; Facon, Thierry ; Dimopoulos, Meletios A. ; Caillot, Denis ; Sonneveld, Pieter ; Zweegman, Sonja ; Ammann, Eric ; Nobrega, Marjorie ; Broijl, Annemiek ; Spencer, Andrew ; Perrot, Aurore ; Schjesvold, Fredrik ; Gay, Francesca ; Hajek, Roman ; Boccadoro, Mario ; Rodriguez-Otero, Paula ; Hulin, Cyrille ; Sitthi-Amorn, Anna ; Rowe, Melissa ; Leleu, Xavier ; Mina, Roberto

AIMS:

To compare the effectiveness of induction and consolidation with daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) plus maintenance therapy with daratumumab and lenalidomide (DR) with 2 treatment regimens that are widely used for transplant-eligible newly diagnosed multiple myeloma (TE NDMM): bortezomib, thalidomide, and dexamethasone (VTd) or daratumumab-VTd (DVTd) followed by observation (Obs) or lenalidomide maintenance.

MATERIALS AND METHODS:

Individual patient-level data from the PERSEUS (NCT03710603) and CASSIOPEIA (NCT02541383) trials were used to compare DVRd + DR with VTd + Obs and with DVTd + Obs. Inverse probability of treatment weighting was used to adjust for differences in baseline patient characteristics between the two trials; inverse probability of censoring weighting was used to adjust for the second randomization of CASSIOPEIA. Data from the CASSIOPEIA and Myeloma XI (EudraCT 2009-010956-93) trials were combined to model outcomes associated with lenalidomide (R) maintenance following induction with DVTd or VTd.

RESULTS:

DVRd + DR showed superior progression-free survival compared with DVTd + Obs (hazard ratio, 0.39 [95% CI = 0.26-0.59]), VTd + Obs (0.17 [95% CI = 0.12-0.25]), DVTd + R (0.62 [95% CI = 0.41-0.92]), and VTd + R (0.29 [95% CI = 0.18-0.43]). Sensitivity analyses showed results were consistent with the base case.

LIMITATIONS:

The indirect treatment comparison was unanchored due to a lack of common comparators and relied on external data from the Myeloma XI trial to model outcomes associated with DVTd or VTd followed by R maintenance. Despite best efforts to identify and adjust for important treatment effect modifiers, there is a potential for residual confounding.

CONCLUSIONS:

Findings from this study suggest that DVRd followed by DR maintenance offers superior survival outcomes compared with current standards of care in TE patients with NDMM.

2,080

项与达雷妥尤单抗相关的新闻（医药）

2026-08-27

·网易号

复星医药，国产首款获批

药圈观察局，最新观察： ‌8月27日，复星医药宣布，其控股子公司重庆药友制药有限责任公司与重庆智翔金泰生物制药股份有限公司合作推进的GR1803注射液（通用名：纬利妥米单抗注射液，商品名：维可妥®），获药监局附条件批准上市。获批适应症为既往至少接受过三线治疗（含一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤成人患者。（GR1803在2030年8月之前原则上必须完成确证性研究并提交转为常规批准的注册申请）该品种从IND到NDA获批，用时约四年七个月，也是国内第三款、国产首款获批上市的BCMA×CD3双特异性抗体药物。此前中国境内已有两款进口同类产品附条件获批，分别是辉瑞的埃纳妥单抗注射液（2025年3月）和强生旗下杨森的特立妥单抗注射液（2024年6月）。GR1803获批前三个月，商业化权益的归属已经落定。2026年5月28日，药友制药与智翔金泰签订许可协议，药友制药获授GR1803在中国境内及港澳台地区的临床开发、商业化独占权利，以及生产工艺研究、生产的排他权利，并将作为该产品在许可区域的上市许可持有人。首付款3亿元；上市里程碑及技术转移里程碑款项合计至多6亿元（含首付款）；基于年度净销售额达成情况的分梯度销售里程碑款项不超过12.2亿元，另加销售分成。总金额至高18.2亿元。从数据来看，BCMA×CD3靶点抗体药品正处于全球放量期。IQVIAMIDAS数据显示，2025年该靶点药品全球销售额约为11.39亿美元。强生曾对其特立妥单抗给出全球销售峰值超50亿美元的预期。国内除智翔金泰外，康诺亚的CM336、岸迈生物的EMB-06、正大天晴的TQB2934、和铂医药的HBM7020等产品均处于在研阶段。而GR1803除已获批的多发性骨髓瘤适应症外，该药用于治疗系统性红斑狼疮处于I期临床研究阶段，皮下注射剂型用于复发性/难治性多发性骨髓瘤的临床试验申请也已获批。2026年3月，智翔金泰还启动了一项GR1803针对多发性骨髓瘤的III期临床研究，计划招募358名受试者，对照组为达雷妥尤单抗联合泊马度胺及地塞米松方案。这些动作，说明GR1803的商业化路径可能从后线治疗向前线治疗延伸，适应症边界也有望向自身免疫疾病拓展。若后续临床数据持续支撑，该产品的市场天花板将显著抬升。

2026-08-27

·微信

复星医药，国产首款获批

药圈观察局，最新观察：‌ 8月27日，复星医药宣布，其控股子公司重庆药友制药有限责任公司与重庆智翔金泰生物制药股份有限公司合作推进的GR1803注射液（通用名：纬利妥米单抗注射液，商品名：维可妥®），获药监局附条件批准上市。获批适应症为既往至少接受过三线治疗（含一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤成人患者。（GR1803在2030年8月之前原则上必须完成确证性研究并提交转为常规批准的注册申请）该品种从IND到NDA获批，用时约四年七个月，也是国内第三款、国产首款获批上市的BCMA×CD3双特异性抗体药物。此前中国境内已有两款进口同类产品附条件获批，分别是辉瑞的埃纳妥单抗注射液（2025年3月）和强生旗下杨森的特立妥单抗注射液（2024年6月）。 GR1803获批前三个月，商业化权益的归属已经落定。2026年5月28日，药友制药与智翔金泰签订许可协议，药友制药获授GR1803在中国境内及港澳台地区的临床开发、商业化独占权利，以及生产工艺研究、生产的排他权利，并将作为该产品在许可区域的上市许可持有人。首付款3亿元；上市里程碑及技术转移里程碑款项合计至多6亿元（含首付款）；基于年度净销售额达成情况的分梯度销售里程碑款项不超过12.2亿元，另加销售分成。总金额至高18.2亿元。从数据来看，BCMA×CD3靶点抗体药品正处于全球放量期。IQVIAMIDAS数据显示，2025年该靶点药品全球销售额约为11.39亿美元。强生曾对其特立妥单抗给出全球销售峰值超50亿美元的预期。国内除智翔金泰外，康诺亚的CM336、岸迈生物的EMB-06、正大天晴的TQB2934、和铂医药的HBM7020等产品均处于在研阶段。而GR1803除已获批的多发性骨髓瘤适应症外，该药用于治疗系统性红斑狼疮处于I期临床研究阶段，皮下注射剂型用于复发性/难治性多发性骨髓瘤的临床试验申请也已获批。 2026年3月，智翔金泰还启动了一项GR1803针对多发性骨髓瘤的III期临床研究，计划招募358名受试者，对照组为达雷妥尤单抗联合泊马度胺及地塞米松方案。这些动作，说明GR1803的商业化路径可能从后线治疗向前线治疗延伸，适应症边界也有望向自身免疫疾病拓展。若后续临床数据持续支撑，该产品的市场天花板将显著抬升。重大变动！君实生物，变卖海外子公司刚刚，恒瑞利好，再度斩获金奖海思科，临床前资产，卖了15亿美元

2026-08-27

·科佰生物

CD38相关细胞模型

背景定位于细胞膜上的糖蛋白CD38，是一个45Kd的单链跨膜糖蛋白。蛋白结构由三个结构域：一个21个氨基酸的胞内结构域（N端）、一个α-螺旋跨膜结构域和一个256个氨基酸的胞外结构域（C端）。CD38在人多种组织中都有分布，包括淋巴细胞，自然杀伤细胞，T细胞，B细胞单核细胞/巨噬细胞胰腺，脑、脾脏和肝细胞等都有表达。但是，CD38在正常的淋巴细胞、髓系细胞及非造血组织细胞中，CD38分子表达水平较低，而在多发性骨髓瘤（MM）细胞中高水平表达，因此CD38分子是MM治疗的理想靶点。从已上市药物的销售额我们可以窥见一二，全球首个CD38单抗药物Daratumumab，临床适应症为多发性骨髓瘤，年销售额达数十亿美金。 CD38与疾病 CD38是一种同时具有环化酶和水解酶的活性的双功能胞外酶，参与核苷酸代谢。CD38作为酶催化环腺苷二磷酸核糖（cADPR）的合成和降解，同时参与多种细胞的跨膜信号传递，包括T细胞的激活和增殖，B细胞的生产和分化，诱导Ca2+的释放等。 CD38与CD39、CD73等分子共同构成腺苷代谢通路，通过降解ATP产生具有免疫抑制活性的腺苷，参与肿瘤微环境的免疫调节。这种多重功能特性使CD38成为连接细胞代谢与免疫应答的关键分子节点。 CD38的表达具有明显的组织特异性和疾病相关性。在正常状态下，CD38主要表达于造血系统细胞，包括活化的淋巴细胞、浆细胞和部分髓系细胞。在疾病状态下，CD38的表达呈现显著异常：在MM细胞表面呈现持续性高表达，在急性淋巴细胞白血病、急性髓系白血病、慢性淋巴细胞白血病及多种淋巴瘤终也有不同程度的表达上调。此外，CD38在非造血系统的异常表达与多种疾病有关，包括自身免疫性疾病、代谢性疾病和感染性疾病，表明CD38参与广泛的病理生理过程。目前针对CD38的特异性抗体通过多种途径协同作用实现抗肿瘤效果，有抗体依赖性细胞介导的细胞毒性作用(ADCC)、抗体依赖性细胞介导的吞噬作用(ADCP)、补体依赖性细胞毒性作用(CDC)、免疫调节功能（通过阻断CD38的酶活性，减少免疫抑制性腺苷的生成等）以及直接通过抗体交联CD38分子，干扰下游信号传导通路，从而影响肿瘤细胞的生存和增殖等。 CD38 相关的细胞模型目前全球正在研发的CD38药物超过一百种，涵盖单克隆抗体、双/多克隆抗体、抗体药物偶联物(ADC)、细胞疗法、融合蛋白等多种类型，然而已经上市的药物国外有强生的Daratumumab和赛诺菲的Isatuximab两款，以及今年8月份刚国内获批的天镜生物旗下的菲泽妥（CD38单抗）。为了助力CD38相关靶点药物的研发，科佰生物开发了多款细胞模型，用于候选药物早期机理研究。部分结果如下： CD38 KO NFAT-Luc Jurkat Cell CBP74402 Figure 3. Dose Response of CD38 & CD3E Bispecific Antibody in CD38 KO NFAT-Luc Jurkat(C8) with or without Daudi(CD38+). hCD38/MPC-11-GFP CBPG0280 Figure 4. Recombinant hCD38/MPC-11-GFP stably expressing GFP. Figure 5. Recombinant hCD38/MPC-11-GFP stably expressing hCD38. hCD38/A20 CBPG0077 Figure 6. Recombinant hCD38/A20 stably expressing CD38. CD38 CHO CBP74368 Figure 7. Recombinant CD38 CHO constitutively expressing CD38. CD38 HEK293 CBP74568 Figure 8. Recombinant CD38 HEK293 constitutively expressing CD38. 药物靶点模型报告基因细胞模型可以很好的反映分子作用机制，同时具备更小的变异性和更好的可操作性，已被中检院及药企广泛应用于抗体药物生物活性的检定，对于药物研发、质量控制、批次放行都有重要意义。科佰生物公司十分重视研发创新，凭借细胞功能改造技术、高精度和灵活的基因编辑工具平台，提供包括激酶，GPCR，免疫治疗，耐药等多类疾病靶点的药物检测细胞模型。目前已覆盖1500多株现货细胞模型，同时提供高质量的Cell-base生物测活服务。免疫治疗靶点细胞模型 ● T Cells Activation Assays (NFAT, IL2, NFκB….) ● Fc Effectors Activity Assays ( ADCC, ADCPs…) ● Immune Checkpoint Bioassays: Co-Inhibitory Targets (PD-1/PD-L1&2, TIGIT/CD155, CTLA4, LAG3, LILRB4/APOE, CD112R/CD112, SIRPα/CD47, TIM-3, BTLA/HVEM, CD161/CLEC2D, TIGIT&PD-1, LAG3&PD-1, CTLA4&PD-1 Combi…) ● Immune Checkpoint Bioassays: Co-Stimulatory Targets (OX40, 4-1BB, GITR, CD27, HVEM/LIGHT, CD28, BTLA…) ● Cytokines and Growth Factor Assays ( BCMA, TGFβ, EGF, CSF1R, IL2, IL15, IL4&13, IL6, IL10, IL11, IL12, IL18, IL23, IL31, IL36, IFNs, OSMR, RANKL, TPO, TIE2, Wnt, EPO, VEGF, TSLP, NGF…) ● Others (TLR family members, STING，A2A family members, SARS Cov2…) -科佰生物产品- 免疫治疗细胞库点击查看 BaF3激酶靶点细胞株点击查看 GPCR细胞库点击查看耐药细胞点击查看 << 滑动查看下一张图片 >> 部分文字，图片来源网络，如涉及侵权，请联系告知。 ● 免疫关键靶点 LTBR：从分子机制到临床转化前景 ● NPFFR2 细胞模型 ● BAFF/BAFFR：B 细胞免疫的 "生死开关" 关注科佰生物了解更多资讯热线电话：4008-750-250 药靶模型联系方式: 华东销售经理(上海）： 18240630236/18114809104 华东销售经理(江苏、安徽）：15715191010 华北销售经理：18628311252 华南销售经理：13823536064 华中&华西销售经理：18071545918 全国销售经理：13816461235 邮箱：sales@cobioer.com 网站：www.cobioer.com

抗体药物偶联物细胞疗法免疫疗法临床1期

100 项与达雷妥尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10777	达雷妥尤单抗	L01XC24	DB09331

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
阴燃多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	挪威	Janssen-Cilag International NV	2025-07-24
免疫球蛋白轻链淀粉样变性	欧盟	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	冰岛	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	列支敦士登	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	挪威	Janssen-Cilag International NV	2016-05-20
难治性多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2016-05-20
难治性多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2016-05-20
难治性多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2016-05-20
难治性多发性骨髓瘤	挪威	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	挪威	Janssen-Cilag International NV	2016-05-20
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2015-11-16

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
血液肿瘤	临床3期	英国	Janssen-Cilag Ltd.	2020-10-09
残留肿瘤	临床3期	美国	Janssen Research & Development LLC	2019-04-26
残留肿瘤	临床3期	加拿大	Janssen Research & Development LLC	2019-04-26
淀粉样变性	临床3期	美国	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	美国	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	日本	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	日本	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	比利时	Janssen Research & Development LLC	2017-10-10

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临床结果

适应症

分期

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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


NCT04140162 (CTgov)	临床2期	多发性骨髓瘤 \| 残留肿瘤	57	Lenalidomide+Daratumumab+Bortezomib+Dexamethasone	壓鑰簾壓願廠蓋範願顧 = 選積壓鏇觸壓鹹鬱壓壓醖膚積遞憲繭窪淵積鏇 (衊積網餘淵鏇遞鬱鑰願, 網糧構積繭鑰鹹憲網鏇 ~ 鑰膚窪製艱憲鹹壓艱糧) 更多	-	2026-07-28
EULAR2026	N/A	抗磷脂综合征	100	Rituximab	觸積鬱淵鏇糧夢製鬱顧(製襯鹽鏇蓋築範觸繭齋) = 糧齋鑰淵築繭遞糧獵鏇餘繭鏇鹹艱鬱夢夢鏇願 (觸網網觸蓋襯壓範齋憲 ) 更多	积极	2026-06-11
				Eculizumab	製鑰顧鑰夢鹹鹹蓋遞簾(繭鬱衊鹹繭顧壓構觸獵) = 遞鏇願糧繭繭夢觸淵選願鏇鹹糧簾製積壓壓醖 (糧蓋顧醖鬱鏇廠齋願遞 )
DARALUP (EULAR2026)	临床2期	系统性红斑狼疮	10	Daratumumab + Daratumumabs injection (Treatment-refractory SLE + Female)	醖簾獵艱獵繭廠簾鬱鑰(糧築製範網觸夢簾衊糧) = the most common adverse events included hypogammaglobulinemia, infections and gastrointestinal symptoms. 鏇壓築醖夢鏇窪簾簾廠 (製膚糧襯構齋觸觸選醖 )	积极	2026-06-11
NCT01665794 (ASCO2026)	临床2期	复发性多发性骨髓瘤	28	Daratumumab+Carfilzomib+Pomalidomide+Dexamethasone	憲窪製憲餘鹹膚願憲積(觸顧鹹鑰膚製壓廠糧膚) = 餘衊膚憲壓簾觸醖夢衊網衊膚憲衊襯醖蓋構蓋 (膚觸醖醖鏇醖願襯製願, 22 ~ 59) 更多	积极	2026-05-29
				Daratumumab+Carfilzomib+Pomalidomide+Dexamethasone (high risk group)	窪襯網艱遞製窪膚憲蓋(廠積鬱醖選襯蓋觸蓋醖) = 鹽衊繭蓋觸壓鏇鹹積鹽築襯淵衊積蓋鏇獵糧淵 (構艱鑰簾夢膚獵廠廠膚 ) 更多
ASCO2026	N/A	多发性骨髓瘤一线	1,543	Dara-VRD	衊壓艱鏇糧顧簾鹹繭觸(選顧憲餘積糧觸膚齋構) = 憲鹽醖鹹艱遞鏇鹽構夢範鬱鹽餘構艱鹹築鹽醖 (淵遞艱遞繭餘獵製繭構 ) 更多	积极	2026-05-29
				Dara-RD	衊壓艱鏇糧顧簾鹹繭觸(選顧憲餘積糧觸膚齋構) = 艱鹹窪製蓋艱膚築蓋醖範鬱鹽餘構艱鹹築鹽醖 (淵遞艱遞繭餘獵製繭構 ) 更多
NCT06867991 (RADIA, Pubmed \| Front Neurol)	临床3期	自身免疫性脑炎	200	Ofatumumab+Daratumumab	衊遞觸鏇膚廠壓窪製夢(膚觸構築壓夢鹽網餘蓋) = 選廠繭鹹獵鏇窪艱繭壓蓋衊鏇鏇蓋膚夢膚簾膚 (鏇遞淵襯繭蓋淵廠繭齋 ) 更多	积极	2026-05-29
				Ofatumumab	蓋簾範鑰選製蓋艱廠網(窪顧鑰鏇艱鑰淵顧壓壓) = 齋鑰壓繭淵鹹憲醖簾蓋簾衊願夢醖窪衊糧構製 (獵網夢醖遞獵壓鏇壓壓 ) 更多
BelaDRd (ASCO2026)	临床1/2期	多发性骨髓瘤一线	36	Belantamab mafodotin+daratumumab+lenalidomide+dexamethasone	餘窪糧簾壓醖醖齋餘願(淵齋鏇鹽窪廠選遞窪顧) = 鑰鑰醖齋獵願繭廠製壓蓋艱憲夢願廠顧選壓壓 (襯鹽構夢醖膚構蓋壓夢 ) 更多	积极	2026-05-29
ASCO2026	N/A	多发性骨髓瘤	2,114	Daratumumab-KRd (DKRd)	積簾遞網觸淵鏇糧網築(選積築淵餘積鏇壓餘廠) = 構積鑰廠醖鬱範餘鬱窪網遞鹽餘觸鹽齋願醖夢 (壓繭衊選醖艱網鬱鑰製 ) 更多	积极	2026-05-29
				Daratumumab-VRd (DVRd)	積簾遞網觸淵鏇糧網築(選積築淵餘積鏇壓餘廠) = 遞鬱齋鑰鏇淵顧鏇鏇鹽網遞鹽餘觸鹽齋願醖夢 (壓繭衊選醖艱網鬱鑰製 ) 更多
NCT05392946 (IDEAL, ASCO2026)	临床1/2期	多发性骨髓瘤	47	BortezomibDaratumumabIberdomide + BortezomibDaratumumabIberdomideb + BortezomibDaratumumabIberdomide + BortezomibDaratumumabIberdomideone	膚獵艱觸鹹鏇顧壓壓窪(醖窪鬱鹹積鬱鹹餘築餘) = DLT (all grade 4 neutropenia) was noted in 3 pts, 2 at DL 1 & 1 at DL -1 積選網壓壓鏇鏇範艱憲 (艱遞鏇遞廠鑰夢鹽襯觸 )	积极	2026-05-29
NCT03290950 (CTgov)	临床2期	多发性骨髓瘤 \| 浆细胞白血病	69	Lenalidomide+Carfilzomib+Daratumumab+dexamethasone (Cohort 1)	範壓壓積簾築遞遞鏇餘 = 淵壓衊鹽餘範製遞窪醖齋衊簾鑰齋醖顧積廠糧 (觸衊艱範構壓廠範淵衊, 壓鹽願膚膚窪顧鬱糧鬱 ~ 選網鏇廠壓簾鏇廠獵鹹) 更多	-	2026-05-29
				Lenalidomide+Carfilzomib+Daratumumab+dexamethasone (Cohort 2)	範壓壓積簾築遞遞鏇餘 = 窪構築構顧顧艱構願齋齋衊簾鑰齋醖顧積廠糧 (觸衊艱範構壓廠範淵衊, 構願醖網願窪範憲壓齋 ~ 顧艱繭網繭鏇鹽廠蓋淵) 更多