西达基奥仑赛(Ciltacabtagene autoleucel) - 药物靶点：BCMA_在研适应症：多发性骨髓瘤，复发性多发性骨髓瘤，阴燃多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

自体CAR-T

别名

BCMA CAR-T、CAR-T cell therapy、cilta-cel

+ [12]

靶点

BCMA

作用方式

调节剂

作用机制

BCMA调节剂(B细胞成熟蛋白调节剂)、免疫细胞毒性、T淋巴细胞替代物

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症

多发性骨髓瘤复发性多发性骨髓瘤阴燃多发性骨髓瘤+ [2]

非在研适应症

复发性浆细胞骨髓瘤

原研机构

南京传奇生物科技有限公司Janssen, Inc.

在研机构

Janssen Research & Development LLC

南京传奇生物科技有限公司

Janssen Biotech, Inc.

+ [5]

非在研机构

Janssen, Inc.

权益机构

南京传奇生物科技有限公司Legend Biotech USA, Inc.

Janssen Biotech, Inc.

+ [2]

最高研发阶段批准上市

首次获批日期

美国 (2022-02-28),

多发性骨髓瘤

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先药物（PRIME） (欧盟)、优先审评 (中国)、突破性疗法 (中国)、特殊审批 (中国)、孤儿药 (韩国)、附条件批准 (欧盟)、孤儿药 (英国)、附条件批准 (中国)

登录后查看时间轴

结构/序列

Sequence Code 13031374

来源: *****

关联

22

项与西达基奥仑赛相关的临床试验

NCT07093554

/ Not yet recruiting临床1期IIT

Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma

This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).

开始日期2025-12-01

申办/合作机构

Medical College of Wisconsin

NCT07149857

/ Recruiting临床2期

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

开始日期2025-10-03

申办/合作机构

Janssen Research & Development LLC

NCT06940297

/ Recruiting临床2期IIT

DART: Phase II Study of Dasatinib and Quercetin in Patients With Relapsed, Refractory Multiple Myeloma Receiving CAR-T Therapy

This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide and fludarabine are given to help kill any remaining cancer cells in the body and to prepare the bone marrow for CAR-T therapy. Chimeric antigen receptor T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory multiple myeloma.

开始日期2025-06-23

申办/合作机构

Mayo Clinic

[+1]

100 项与西达基奥仑赛相关的临床结果

登录后查看更多信息

100 项与西达基奥仑赛相关的转化医学

登录后查看更多信息

100 项与西达基奥仑赛相关的专利（医药）

登录后查看更多信息

354

项与西达基奥仑赛相关的文献（医药）

2025-12-31·Hematology

BCMA CAR-T therapy as salvage therapy in patients with plasmablastic myeloma

Article

作者: Jin, Chengwei ; Zhu, Jun ; Li, Su ; Deng, Jing ; Kang, Liqing ; Jiang, Ying

OBJECTIVES:

Plasmablastic myeloma (PBM) is a variant of multiple myeloma associated with a poor prognosis. We investigated the efficacy and safety of B-cell maturation antigen (BCMA) chimeric antigen receptor T cell (CAR-T) therapy in patients with PBM.

METHODS:

The study comprised six patients diagnosed with PBM between January 1, 2023 and December 31, 2023. The patients received BCMA single-target CAR-T therapy or BMCA/CD19 dual-target CAR-T therapy, with some patients undergoing hematopoietic stem cell transplantation before treatment. The median patient age was 55.5 years (range, 41-63). Four patients exhibited high-risk cytogenetic abnormalities.

RESULTS:

The objective response rate (ORR) was 83.3%, with four of six patients achieving a complete response or better and three of six achieving a strigent complete response. Two patients exhibited progression-free survival (PFS) of at least 6 months, one of whom succumbed to a pulmonary infection, whereas four patients died of disease progression. Cytokine release syndrome (CRS) was observed in all patients, three of whom experienced grade 3-4 CRS. Two patients experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome. There were no CRS-related deaths.

CONCLUSION:

BCMA CAR-T therapy was safe and effective as a salvage treatment for PBM, and its toxicity was controllable. Future research will examine the use of CAR-T therapy as part of combination regimens.

2025-12-31·Human Vaccines & Immunotherapeutics

The hotspots and publication trends in glioblastoma and CAR-T immunotherapy: A bibliometric analysis

Article

作者: Xie, Yun ; Gu, Jingyu ; Nong, Xun ; Song, Zhaoming ; Chen, Zhouqing ; Guo, Yanao ; Yang, Chen ; Wang, Zhong ; Qu, Ruisi

In recent years, chimeric antigen receptor T cell (CAR-T) immunotherapy has made considerable progress in the treatment of glioblastoma. The aim of this study was to comprehensively explore the prospects and future trends of CAR-T immunotherapy for glioblastoma through systematic bibliometric analysis. Publications pertaining to glioblastoma and CAR-T immunotherapy from 2008 to 2024 were extracted from the Web of Science Core Collection. Utilizing VOSviewer (version 1.6.20), CiteSpace (version 6.3.R1), and R 4.3.3, this study concentrated on evaluating contributions from countries, institutions, authors, and journals, while also identifying research hotspots and emerging trends. A total of 570 publications were identified, demonstrating an annual growth rate of 31.71%. The USA led the field with 269 publications, followed by China (113). The University of Pennsylvania, Harvard University, and the University of California System emerged as the most prolific institutions. Frontiers in Immunology published the most articles (42), while Clinical Cancer Research garnered the highest number of citations (2,867). Recent keyword bursts (2022-2024) underscored an increasing focus on combination therapy approaches and outcomes, particularly emphasizing "radiotherapy" (strength 3.49), "solid tumor" (strength 3.49), and "efficacy" (strength 2.79). In recent years, research on CAR-T immunotherapy for glioblastoma has gradually shifted from the exploration of basic mechanisms to the application of clinical combination therapy, and this shift in research direction indicates that CAR-T immunotherapy has a relatively mature technology and great clinical translation potential. In the coming years, CAR-T immunotherapy is expected to usher in a golden era and benefit more patients suffering from glioblastoma.

2025-11-01·CURRENT OPINION IN HEMATOLOGY

Advances in chimeric antigen receptor-T therapies to target tumor resistance in B-cell malignancies

Article

作者: Hamieh, Mohamad ; Salem, Nassim

Purpose of review:

Chimeric Antigen Receptor T cell (CAR-T) has transformed B-cell malignancies treatment, with seven FDA-approved therapies to date. Despite remarkable success, a substantial fraction of patients relapse, primarily due to limited CAR-T persistence or tumor escape driven by target-antigen loss. Here, we highlight preclinical and clinical advances in programming T cells to address these challenges and are poised to drive next-generation CAR-T development.

Recent findings:

Building on FDA-approved CAR designs, innovations in tailoring CAR signaling, cytokine armoring, and multiantigen targeting are paving the way toward more effective and safer treatments. Satisfyingly, these new approaches have demonstrated feasibility, safety, and promising clinical activity, including in patients relapsing after prior CAR treatment. In parallel, CARs with enhanced sensitivity to low-antigen tumors are advancing from preclinical to clinical development. These innovations aiming to enhance T cell persistence and counter tumor escape are defining the next wave of CAR therapies.

Summary:

Here, we outline key advances in CAR-T programming to improve persistence, broaden antigen targeting, and enhance efficacy in B-cell malignancies. While challenges such as toxicities or identifying optimal and standardized approaches across trials remain to be addressed, these approaches provide a foundation for translating innovations into effective and potentially curative CAR immunotherapies.

1,538

项与西达基奥仑赛相关的新闻（医药）

2025-10-10

·抗体圈

贝林妥欧单抗治疗后CAR-T治疗的临床实践

在B细胞急性淋巴细胞白血病（B-ALL）的治疗领域，贝林妥欧单抗（blinatumomab）和CAR-T细胞疗法已成为革命性的治疗选择。然而，当这两种疗法序贯应用时，临床医生面临着独特的挑战和机遇。本文基于研究文献，系统分析贝林妥欧单抗治疗后进行CAR-T治疗的关键注意事项，并比较其与未接受贝林妥欧单抗治疗患者的疗效和安全性差异。治疗前的精准评估：奠定成功基础 CD19表达水平的细致评估是治疗前准备工作的核心环节。研究表明，贝林妥欧单抗治疗可能导致CD19表达下调甚至完全缺失，这将直接影响后续CAR-T治疗的疗效。文献1（Pillai等，Blood Advances 2019）显示，约12%患者在CAR-T治疗前表现为CD19-dim，其中21%曾接受贝林妥欧单抗治疗。而文献3（Chu等，Blood Cancer Journal 2025）的最新数据表明，贝林妥欧单抗暴露组患者CD19 dim/部分表达率(36.4%)显著高于未暴露组(22.5%)。疾病负荷的精确量化同样至关重要。文献1的研究表明，高疾病负荷（骨髓中位CD19疾病负担51.88%）与CD19-MRD/复发和非应答显著相关。因此，治疗前应尽可能通过骨髓活检和流式细胞术准确评估疾病负荷。治疗间隔时间的优化需要个体化考量。文献3数据显示，贝林妥欧单抗末次给药至CAR-T输注的中位时间为51.5天（范围13-211天），而文献2（Marschollek等，Biomedicines 2022）报道的中位间隔时间仅为13.5天，主要用于降低采集前疾病负荷。治疗中的精细管理：平衡疗效与安全 CAR-T细胞产品的选择策略应根据患者既往治疗史个体化制定。文献3的临床实践表明，CD19/CD22双靶点CAR-T可能对CD19抗原丢失患者更具优势。而文献1的基础研究证实，CAR-T细胞能够识别极低水平的CD19表达（低至0.02μg CD19 mRNA），这为CD19-dim患者仍可能从CAR-T治疗中获益提供了科学依据。细胞因子释放综合征(CRS)的预警监测需要格外重视。文献3发现贝林妥欧单抗暴露组患者CAR-T治疗后炎症因子（如TNF-α、IFN-γ和IL-6等）峰值水平显著升高，1-2级CRS发生率高达72.7%，较未暴露组(47.7%)明显增加（p=0.054）。这一发现提示对于既往接受过贝林妥欧单抗治疗的患者，应提前做好CRS的预防和管理准备。神经毒性的监测体系同样不容忽视。虽然三篇文献均显示两组间免疫效应细胞相关神经毒性综合征(ICANS)发生率无显著差异，但仍需按照ASTCT共识分级标准进行规范评估，特别是在使用双靶点CAR-T产品时。治疗后的长期随访：预防复发与提高生存微小残留病(MRD)的动态监测是疗效评估的核心。文献2（Marschollek等）建议在CAR-T输注后第28天进行系统评估，此时文献2中6/7患者(85.7%)达到MRD阴性。值得注意的是，文献1强调需区分CD19+和CD19-复发模式，前者多与CAR-T细胞功能丧失相关，后者则可能伴随CAR-T细胞持续存在。 B细胞再生障碍的监测可作为CAR-T细胞功能的替代指标。文献1报道B细胞再生障碍的中位持续时间与治疗效果密切相关，而文献2中1例患者在复发后仍保持B细胞再生障碍达4个月，这一现象值得临床关注。复发患者的挽救治疗策略需要多学科讨论。文献2中3例CD19阴性复发患者，2例死亡，1例通过造血干细胞移植成功挽救；而文献1建议对CD19阴性复发患者考虑靶向替代抗原的治疗方案，如CD22或双靶点CAR-T。疗效与安全性的循证比较缓解率的差异具有统计学和临床意义。文献3的多中心数据显示，贝林妥欧单抗暴露组CAR-T治疗的完全缓解率(CRR)为68.2%，显著低于未暴露组的90.9%(p=0.033)。文献1的研究也发现贝林妥欧单抗治疗史与更高的MRD阳性缓解失败率和CD19阴性MRD/复发率相关(p=0.043)。生存结局的长期随访结果较为复杂。文献3中两组总生存期(OS)和无复发生存期(RFS)无显著差异，中位RFS为8.5个月；而文献2的中期随访显示4/7患者(57.1%)在中位随访497天后仍保持完全缓解，提示部分患者可获得持久缓解。复发模式的转变值得警惕。文献1报道39例CD19阴性复发，其中6例曾接受贝林妥欧单抗治疗；文献2中所有复发均为CD19阴性；文献3发现贝林妥欧单抗暴露组CD19阴性表达率相对较高(25.0% vs 0%)。这些数据一致提示抗原逃逸是主要复发机制之一。基于现有证据，提出以下临床实践建议： 1.患者选择的精准化：对于高疾病负荷患者，贝林妥欧单抗可作为有效的桥接治疗（文献2）；而CD19表达dim或既往贝林妥欧单抗治疗失败患者可能更适合双靶点CAR-T（文献3） 2.治疗方案的优化：综合考虑贝林妥欧单抗与CAR-T的治疗顺序和间隔时间（文献1,3）；对CD19表达dim患者仍可尝试CAR-T治疗，但需密切监测（文献1） 3.复发预防的综合策略：对CD19表达弱或贝林妥欧单抗治疗后患者，建议CAR-T后考虑巩固治疗（如HSCT）（文献2,3）；同时开发针对CD19阴性复发的多靶点补救策略（文献1,2）。未来研究方向应包括：开发预测贝林妥欧单抗治疗后CAR-T疗效的生物标志物优化双靶点CAR-T的临床应用策略探索克服抗原逃逸的新型免疫治疗方法参考文献 Pillai V, et al. CAR T-cell therapy is effective for CD19-dim B-lymphoblastic leukemia but is impacted by prior blinatumomab therapy. Blood Adv. 2019;3(22):3539-3549. Marschollek P, et al. Blinatumomab Prior to CAR-T Cell Therapy-A Treatment Option Worth Consideration for High Disease Burden. Biomedicines. 2022;10(11):2915. Chu Y, et al. Efficacy and safety of CAR-T cell therapy in B-ALL patients previously treated with blinatumomab. Blood Cancer J. 2025;15:11. Myers RM, et al. Blinatumomab Nonresponse and High-Disease Burden Are Associated With Inferior Outcomes After CD19-CAR for B-ALL. J Clin Oncol. 2022;40(9):932-944. Mejstrikova E, et al. CD19-negative relapse of pediatric B-cell precursor acute lymphoblastic leukemia following blinatumomab treatment. Blood Cancer J. 2017;7(12):659.

细胞疗法免疫疗法信使RNA

2025-10-10

·美通社

陆道培医院血液科张弦主任在Blood Advances发表BCMA CAR-T细胞疗法最新临床研究成果

北京 2025年10月9日 /美通社/ -- 近日，国际血液学期刊 Blood Advances 杂志发表了陆道培医学团队一项前瞻性临床研究，张弦主任为第一作者，陆佩华院长为通讯作者，题为《Efficacy and safety of BCMA nanobody CAR T-cell therapy in relapsed or refractory plasma cell myeloma》（BCMA纳米抗体CAR-T细胞疗法在复发/难治性浆细胞性骨髓瘤中的疗效与安全性），报道了应用纳米体的BCMA CAR-T细胞治疗多线治疗后难治复发的浆细胞肿瘤的突破性临床研究成果。研究背景复发/难治性多发性骨髓瘤（R/R MM）患者，尤其是伴有髓外病灶、中枢神经系统（CNS）侵犯或高危遗传学异常的患者，预后极差。B细胞成熟抗原（BCMA）CAR-T细胞治疗为这类患者带来了新的治疗希望，但传统单链可变片段（scFv）构建的CAR-T疗效受抗原丢失、免疫原性和细胞持久性限制。本研究评估一种新型双纳米抗体（ dual-VHH ） BCMA CAR-T 细胞的安全性和疗效。研究方法研究共纳入 27 例复杂 / 高危的 R/R 浆细胞肿瘤患者，其中包括22例多发性骨髓瘤，4例浆细胞白血病、1例间变型浆细胞瘤。其中，11例伴多发髓外病灶（含3例CNS侵犯）及11例高危遗传学异常患者（如TP53突变）。患者接受1×10^6/kg（范围0.3–2×10^6/kg）剂量BCMA CAR-T细胞静脉回输。主要终点为总缓解率（ORR）及安全性，次要终点包括缓解深度、缓解持续时间（DOR）、无进展生存（PFS）、总生存（OS）。研究结果结果显示，BCMA CAR-T细胞输注后3个月的总体缓解率（ORR）达到100%，深度缓解率（CR+VGPR）81.5%，中位缓解(DOR)持续时间11个月（2-36个月）。高危遗传学患者3个月CR率72.7%，1年PFS 65.5%，3例CNS患者均缓解，其中2例达CR，间变型浆细胞瘤患者经治疗后骨髓MRD转阴，肿瘤显著缩小，运动功能恢复。安全性方面，该治疗的不良反应主要为低级别细胞因子释放综合征（CRS）和轻度神经毒性，主要并发症为感染，可通过积极干预得到管理。结论双纳米体的BCMA CAR-T疗法在治疗多线治疗后难治复发的浆细胞肿瘤患者中显示出很好的治疗效果和安全性，特别是在高危患者，包括伴有髓外病灶、高危细胞遗传学异常、浆细胞白血病及间变型浆细胞瘤的患者中表现出良好效果。该研究为优化 BCMA CAR-T治疗策略、改善浆细胞肿瘤患者长期预后提供了有力证据。作为国内最早涉足BCMA CAR-T治疗的中心之一，截止目前，陆道培医疗团队已完成百余例BCMA CAR-T临床应用，在髓外病变、中枢神经系统侵犯以及多线复发患者中，积累了丰富的临床实践经验。本次发表的临床研究数据进一步验证了纳米抗体BCMA CAR-T的显著优势，为制定更为精准的临床治疗方案提供了有力支持。未来，陆道培医院将持续深耕CAR-T细胞治疗领域，深入探索其与造血干细胞移植、抗体药物及小分子靶向药物的联合治疗策略，致力于推进个体化、精准化的治疗路径，惠及更多国内外患者，切实提升其生存质量与长期预后。

细胞疗法免疫疗法临床结果临床研究

2025-10-09

·生物制药小编

未来纳米抗体的专利战可能往在这个方向打

纳米抗体（Nbs）是从骆驼科动物或某些软骨鱼类的重链抗体中提取的单域抗体片段（VHH）。与传统抗体相比，Nbs 具有体积小、稳定性高、亲和力强、易改造等优势，尤其在靶向传统抗体难以触及的表位方面表现突出。自2018年起，已经有多个纳米抗体药物或相关药物获批上市（如赛诺菲的Caplacizumab、康宁杰瑞的Envafolimab、Ablynx的Ozoralizumab、传奇生物的Cilta-cel）。不过，对于其技术发展的未来方向和流行趋势比较缺乏了解。近日，一组来自重庆理工大学，澳门大学，大连医科大学的联合研究团队通过对BCMA纳米抗体技术的专利全景分析，试图构建出一副关于BCMA纳米抗体的全景蓝图，通过挖掘专利数据，进一步分析了针对BCMA Nbs的专利序列和结构特性，研究人员认为，这一研究将促进Nbs的药物开发和未来专利战略策略。数据挖掘该研究利用了Derwent Innovation数据库（德温特世界专利索引），通过构建基于纳米抗体及其变体的检索策略，共检索到12,619个DWPI专利家族（59,839条专利记录）。由于一般来说，BCMA相关专利主要涉及自免，癌症和传染病，大多数专利内容归类为治疗、诊断和生产，为了确保尽量消除疫情这个黑天鹅事件而导致的发表偏移，研究人员专门排除了SARS-CoV-2相关的专利。经过系统筛选和过滤后，研究人员最终确定2,812个关键专利家族（15,363条专利记录）用于进一步分析。分析这些专利的数据表明，自从在2018年首个Nb药物获得批准后，专利数量显著增加。Nb相关技术分为九类，大多数专利(93%)与前五类相关:单克隆Nbs、多特异性Nbs、重组蛋白、细胞疗法和基于VHH的缀合物。中国和美国在专利申请数量上领先，是专利出版物的主要目的地，其次是欧洲、日本、澳大利亚和加拿大。（如下图所示）而在主要专利权人方面，Sanofi（2018年赛诺菲39亿欧元收购比利时纳米抗体公司Ablynx）持有最多专利；其他包括GSK、Merck、Legend Biotech等；学术机构如VIB、VUB、Ghent University也占据重要地位。自从比利时科学家Cécile Casterman、Raymond Hamers和Serge Muyldermans发现Nb抗体以来，比利时一直是Nb创新的关键国家。值得注意的是，传奇生物被认为是第九个开发出首个基于VHH的CAR-T细胞疗法的受让人，这代表了基于细胞免疫疗法Nb的重大进步。数据网络分析通过构建专利引用网络，研究还揭示了纳米抗体技术的创新生态和关键专利。比如说，最具影响力（被引用最多）的专利是WO1994004678A1（Nb的原始发现专利），作为纳米抗体技术的奠基性专利，该专利对后续创新产生了深远影响，最初就是由由VUB的Cécile Casterman和Raymond Hamers于1994年提交。后来VUB的技术转化诞生了Ablynx，Ablynx自然也在多项专利的技术流动中处于核心地位。序列特征分析有介于传奇生物基于Nb抗体的BCMA CAR-T已经获批，研究人员认为这一里程碑时刻给了分析BCMA Nbs的必要性，因为这不仅仅是证明了Nbs的治疗潜力，还表明Nbs还可f以再更多领域（细胞治疗）进行应用。研究人员发现，针对BCMA的专利主要集中在单价/多价Nbs和细胞疗法上。这里，他们总共选择了39个BCMA相关序列进行分析。研究表明，这些CAR-T的CDR区存在保守 motifs，这些保守残基可能在抗原结合和结构稳定性中起关键作用。研究人员还比较了序列同一性。他们发现，这样一个有趣的事实，一些具有不同序列的Nbs可能共享相似的结构。这或许是一种有趣的“殊途同归”。在修饰位点分析中，研究人员发现，CDR与FR区域的修饰位点分布存在显著差异。CDR2易发生天冬氨酸异构化（AIS），可能影响结合；FR2易发生甲硫氨酸氧化（MOE），可能影响稳定性。最后研究人员使用了AlphaFold3去预测纳米抗体及其与BCMA抗原的结合模式，预测显示Nb主要结合BCMA的中央结构域（如E12, L18, H19等残基）；由于不同专利中的Nb可能竞争相同表位……所以到时候可能在这些地方出现专利战…… 总结总的来说，这项研究为未来Nbs的专利战可能需要注意的事项提供了先见之明，比如说针对BCMA的专利主要集中在单价/多价Nbs和细胞疗法上。一些企业在Nb上的开发过程中可能需要注意抗原表位的竞争，这关系到对手会不会进行专利战。参考来源： Xu, J., Wang, Y., Yuan, N., Hu, G., & Hu, Y. (2025). Exploring the nanobody patent landscape: a focus on BCMA sequences and structural analysis. mAbs, 17(1). https://doi.org/10.1080/19420862.2025.2560893

免疫疗法细胞疗法并购专利到期上市批准

100 项与西达基奥仑赛相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
多发性骨髓瘤	美国	南京传奇生物科技有限公司	2022-02-28
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2022-02-28

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
复发性多发性骨髓瘤	临床3期	美国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	日本	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	澳大利亚	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	比利时	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	丹麦	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	法国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	德国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	希腊	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	以色列	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	意大利	Janssen Research & Development LLC	2020-06-12

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04181827 (CARTITUDE-4, ASCO2025) 人工标引	临床3期	多发性骨髓瘤	419	Ciltacabtagene autoleucel (cilta-cel) (pts with extramedullary disease (EMD)	壓製願鏇淵鏇繭壓顧艱(淵願製艱鏇築鏇齋餘襯) = 齋願蓋衊餘製醖獵鬱齋壓遞繭膚簾獵醖窪醖艱 (簾鹽鬱糧夢遞襯醖顧製 ) 更多	积极	2025-05-30
				Standard of Care (SOC) (pts with extramedullary disease (EMD)	壓製願鏇淵鏇繭壓顧艱(淵願製艱鏇築鏇齋餘襯) = 艱簾鏇鹹鑰鑰齋夢構餘壓遞繭膚簾獵醖窪醖艱 (簾鹽鬱糧夢遞襯醖顧製 ) 更多
Cartitude 1 and 4 (ASCO2025)	N/A	难治性多发性骨髓瘤	140	ciltacabtagene-autoleucel (Patients with CNP)	醖膚艱顧範齋觸糧壓壓(窪鹹壓顧築齋夢鏇鹽獵) = 淵鑰鹽鏇製鹽膚醖醖醖憲觸獵蓋鬱積願餘鑰顧 (築積繭膚鑰選製獵齋觸 ) 更多	积极	2025-05-30
NCT03548207 (CARTITUDE-1, ASCO2025)	临床1/2期	复发性多发性骨髓瘤 hemoglobin \| platelets \| effector-to-target ratio	97	Ciltacabtagene autoleucel (cilta-cel)	範鏇鹹顧積構積遞鹹壓(構願鬱壓鹹淵壓襯鏇鑰) = 鹹遞壓顧鏇遞築願鹽廠簾憲襯選夢衊觸製簾範 (壓壓製襯簾願糧蓋網糧, 41.9 ~ NE) 更多	积极	2025-05-30
CARTITUDE-4 (EHA2025)	N/A	复发性多发性骨髓瘤 lenalidomide-refractory	-	Ciltacabtagene autoleucel (cilta-cel)	壓網膚鏇憲選艱築遞積(鑰製窪構淵醖廠製觸鬱) = 鏇願鬱獵蓋鏇鑰積願遞壓選廠鏇衊窪糧鹽衊膚 (蓋壓築顧積顧齋淵衊餘 ) 更多	积极	2025-05-22
				Standard of care (PVd or DPd)	壓網膚鏇憲選艱築遞積(鑰製窪構淵醖廠製觸鬱) = 襯製醖糧窪顧糧糧窪範壓選廠鏇衊窪糧鹽衊膚 (蓋壓築顧積顧齋淵衊餘 ) 更多
NCT05201781 (CARTITUDE-1, EHA2025)	临床4期	复发性多发性骨髓瘤 hemoglobin \| platelets \| effector-to-target ratio	97	Ciltacabtagene autoleucel	淵壓蓋鹽積範糧遞網壓(觸網遞構獵衊願遞窪鹽) = 鏇繭膚網願顧願鹽夢憲顧醖築遞膚願鏇蓋壓糧 (齋醖築構壓醖鑰壓網構 ) 更多	积极	2025-05-22
NCT04181827 (CARTITUDE-4, CTgov)	临床3期	复发性多发性骨髓瘤 \| 多发性骨髓瘤	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	齋獵遞淵淵遞艱獵鑰鏇(醖構選廠網鏇齋遞鹽築) = 選製範網網襯淵願糧餘範憲築衊遞艱簾網鏇簾 (願襯齋衊淵蓋鬱構構醖, 鹹鑰鑰鑰鏇鑰艱築醖醖 ~ 獵憲膚鬱齋淵簾鹹衊艱) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	齋獵遞淵淵遞艱獵鑰鏇(醖構選廠網鏇齋遞鹽築) = 觸齋醖廠範糧壓鹹夢廠範憲築衊遞艱簾網鏇簾 (願襯齋衊淵蓋鬱構構醖, 憲襯膚鏇獵構淵膚構憲 ~ 繭鹹鹹艱簾鏇築餘簾繭) 更多
CARTITUDE-1 (EHA2025)	N/A	难治性多发性骨髓瘤	105	Ciltacabtagene autoleucel	構遞醖壓選衊艱糧簾築(壓衊築顧衊糧製醖膚構) = Infections occurred in 49% of patients and were severe in 32%. Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%). Later infections between days 31-100, and after day 100 were mostly viral (59% and 60%), with only 32% and 12% being grade ≥3 at each time period. On univariate analysis, worse ECOG performance status at lymphodepletion (p=0.012), higher maximum grade of CRS (p=0.036), steroid and anakinra use (p=0.042 and p=0.024), and lower IgA levels at day 90 (p=0.014) were associated with severe infections. At the end of follow-up, 16 patients had expired. Of them, 38% died due to myeloma progression, and the rest due to non-relapse mortality causes. The most common cause of non-relapse mortality was infection (31% of all deaths) 膚襯網顧夢鹹憲鹹窪選 (鏇憲鏇鹽顧築簾壓範築 )	-	2025-05-14
PB3088 (EHA2025)	N/A	复发性多发性骨髓瘤	-	BCMA CAR-T (EMD-negative patients)	獵夢範窪構餘憲鬱餘選(艱齋糧蓋網衊繭襯醖壓) = 製憲築顧獵選夢選齋鹽顧構築網壓齋淵壓繭鬱 (蓋構廠範餘範願艱鹹鏇, 0.42 ~ 0.59) 更多	-	2025-05-14
				BCMA CAR-T (EMD-positive patients)	獵夢範窪構餘憲鬱餘選(艱齋糧蓋網衊繭襯醖壓) = 遞鏇餘願鹽簾範壓膚願顧構築網壓齋淵壓繭鬱 (蓋構廠範餘範願艱鹹鏇, 0.32 ~ 0.51) 更多
PB2891 (EHA2025)	临床3期	BCMA	-	Belantamab mafodotin plus bortezomib/dexamethasone	憲顧糧積廠鹹獵窪蓋鏇(鹹顧願製鑰夢獵窪衊積): HR = 0.67 (95% CI, 0.26 ~ 1.75)	积极	2025-05-14
				Ciltacabtagene autoleucel
PS2152 (EHA2025)	N/A	多发性骨髓瘤	235	Cilta-cel	鏇構艱獵齋艱淵夢顧艱(觸蓋繭糧艱顧製構蓋選) = 積獵鑰鑰遞顧壓積襯鏇壓淵鹽構廠齋範鑰鑰願 (積憲網簾衊鬱壓膚窪製 ) 更多	-	2025-05-14
				Cilta-Cel (Control group)	鏇構艱獵齋艱淵夢顧艱(觸蓋繭糧艱顧製構蓋選) = 築鹹積膚顧鹽願觸繭夢壓淵鹽構廠齋範鑰鑰願 (積憲網簾衊鬱壓膚窪製 ) 更多