利基迈仑赛(Lisocabtagene maraleucel) - 药物靶点：CD19_在研适应症：复发性滤泡性淋巴瘤，难治性滤泡性淋巴瘤，套细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

自体CAR-T

别名

anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy、anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy、CD19-directed chimeric antigen receptor T cell therapy

+ [7]

靶点

CD19

作用方式

调节剂

作用机制

CD19调节剂(B淋巴细胞抗原CD19调节剂)、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

复发性滤泡性淋巴瘤难治性滤泡性淋巴瘤套细胞淋巴瘤+ [30]

非在研适应症

前体B细胞急性淋巴细胞白血病T细胞/组织细胞丰富的大B细胞淋巴瘤

原研机构

Fred Hutchinson Cancer Research Center

Bristol Myers Squibb Co.

在研机构

Bristol Myers Squibb Co.Bristol-Myers Squibb Pharma EEIG

Celgene Corp.

+ [3]

非在研机构-

权益机构

Fred Hutchinson Cancer Research Center

Juno Therapeutics, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2021-02-05),

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)-

特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)

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结构/序列

Sequence Code 133531

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Sequence Code 133534

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Sequence Code 133555

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Sequence Code 133567

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Sequence Code 133586

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Sequence Code 171111

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关联

28

项与利基迈仑赛相关的临床试验

NCT07098364

/ Recruiting临床1/2期IIT

A Phase 1/2 Open-Label Study Evaluating the Safety and Efficacy of ST-067 in Combination With CD19-Directed CAR T-Cell Therapy in Patients With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

This phase I/II trial tests the safety, side effects, and best dose/regimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed/refractory LBCL.

开始日期2025-11-01

申办/合作机构

Fred Hutchinson Cancer Research Center

[+1]

NCT07015242

/ Not yet recruiting临床2期

The CAROLYN Trial: Lisocabtagene Maraleucelas First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).

开始日期2025-10-31

申办/合作机构

Juno Therapeutics, Inc.

NCT07194980

/ Not yet recruiting临床2期IIT

Safety and Efficacy of the Addition of Nemtabrutinib to Lisocabtagene Maraleucel in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

This phase II trial studies how well the addition of nemtabrutinib to lisocabtagene maraleucel in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Nemtabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lisocabtagene maraleucel is a type of treatment called chimeric antigen receptor (CAR) T-cell therapy, 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 (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment. Adding nemtabrutinib to lisocabtagene maraleucel may be an effective treatment for relapsed/refractory CLL/SLL.

开始日期2025-10-01

申办/合作机构

Fred Hutchinson Cancer Research Center

[+1]

100 项与利基迈仑赛相关的临床结果

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100 项与利基迈仑赛相关的转化医学

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100 项与利基迈仑赛相关的专利（医药）

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199

项与利基迈仑赛相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

作者: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

2025-11-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

From R-CHOP to revolution: How CAR T-Cells, ADCs, and bispecific antibodies are transforming DLBCL treatment

Review

作者: Hachem, Maria Catherine Rita ; Mohanna, Rami ; Farhat, Mohamad ; El Khoury, Bechara ; Kourie, Hampig Raphael ; Assi, Ahmad

BACKGROUND:

Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive subtype of non-Hodgkin lymphoma, with R-CHOP as the standard first-line treatment. However, many patients experience relapse or refractory disease, prompting the need for new therapeutic approaches. Recent advances, including chimeric antigen receptor (CAR) T-cell therapies, antibody-drug conjugates (ADCs), bispecific antibodies (bsAbs), immunomodulators, and Exportin-1 (XPO-1) inhibitors have transformed treatment strategies.

METHODS:

A comprehensive literature review was conducted using PubMed up to January 2025. Boolean operators and MeSH terms "Lymphoma", "Large-B-cell" and "Diffuse" along with DLBCL-related keywords, were utilized following thorough examination of existing literature.

RESULTS:

CAR T-cell therapies, and particularly axicabtagene ciloleucel and lisocabtagene maraleucel, demonstrated superior event-free survival and overall survival. ADCs, such as polatuzumab vedotin, improved PFS with a manageable toxicity profile, while bsAbs like glofitamab and epcoritamab showed high response rates in relapsed or refractory DLBCL. Major toxicities from these new treatments include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

CONCLUSION:

Novel therapies have significantly improved DLBCL outcomes, however challenges remain, including treatment toxicity, accessibility, and variability in patients' response. Future research should aim to optimize combination therapies, identify biomarkers predictive of response, and enhance toxicity management to improve patient care.

2025-10-14·Blood Advances

Linhares Y, Freytes CO, Cherry M, et al. OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL. Blood Adv. 2024;8(23):6114-6126.

Article

700

项与利基迈仑赛相关的新闻（医药）

2025-10-17

·FiercePharma

Sanofi gets one thumbs-up, one thumbs-down from Europe's CHMP

Europe's Committee for Medicinal Products for Human Use has turned down Sanofi's Rezurock while also offering a positive opinion for the company's thrombocytopenia treatment Wayrilz. Europe’s Committee for Medicinal Products for Human Use (CHMP) has given a thumbs-down (PDF) to Sanofi’s Rezurock as a third-line treatment for chronic graft-versus-host disease (cGVHD).The European Medicines Agency’s panel of experts issued its negative opinion because it “was difficult to quantify” the effect Rezurock had on patients relative to other treatments. Additionally, the CHMP noted that a study in which patients used Rezurock as a first-line treatment “did not show it had any beneficial effects.”The CHMP also stated that due to the need for new treatments in this indication, it considered recommending Rezurock for a conditional marking nod. But the regulator ultimately decided not to, given that Sanofi isn't in a position to provide more efficacy data on the drug until 2030.The company plans to seek a reexamination of the opinion.“Sanofi is confident in the body of clinical and real-world evidence that underscores Rezurock’s consistent efficacy and well-established safety profile,” Olivier Charmeil, Sanofi’s executive vice president of general medicines, said in a release. “We will continue to work closely with the European Medicines Agency with the aim of bringing this treatment to patients in the EU who are waiting.” Out of 93 recommendations this year on new medicines, the Rezurock snub represents the sixth negative opinion from the CHMP so far. Sanofi gained Rezurock in a $1.9 billion buyout of Kadmon in 2021, less than two months after the FDA approved the treatment for third-line use in cGVHD. Today, the medicine is available in 20 countries, including the U.K., Canada and China.More than 17,000 patients have been prescribed Rezurock since its initial U.S. nod, Sanofi said Friday. Sales of the treatment reached 132 million euros ($154 million) in the first half of this year, which was a 21% increase over the same period in 2024.A whirlwind of endorsements It wasn't all bad news for Sanofi this week, however, as the CHMP recommended the company’s Bruton tyrosine kinase (BTK) inhibitor Wayrilz for approval to treat immune thrombocytopenia in adult patients who are refractory to other therapies.The positive opinion comes after the FDA approved the potential blockbuster in August. Sanofi gained the drug—along with another BTK hopeful tolebrutinib—in 2020 through its $3.7 billion acquisition of Principia Biopharma.The CHMP also signed off on Insmed’s first-in-class treatment Brinsupri for non-cystic fibrosis bronchiectasis. The recommendation comes two months after the FDA endorsed the dipeptidyl peptidase 1 (DPP1) inhibitor. The oral treatment is indicated for patients ages 12 and older who have had at least two flare-ups of the lung disorder over the previous year. Apart from the new drug endorsements, the CHMP issued further positive opinions this week, which would expand the label for eight previously approved drugs, including Pfizer’s COVID antiviral Paxlovid, Johnson & Johnson’s autoimmune treatment Tremfya, Regeneron’s skin and lung cancer therapy Libtayo, Agios’ anemia drug Pyrukynd and CStone’s lung cancer medicine Cejemly. Also making the grade were the following blood cancer drugs: Bristol Myers Squibb’s Breyanzi, Roche’s Gazyvaro and Novartis’ Scemblix.

上市批准并购临床结果

2025-10-17

·EndPoints

CHMP rejects Sanofi’s Rezurock over clinical data issues, but recommends BTK inhibitor Wayrilz

The European Medicines Agency’s human medicines committee (CHMP) rejected Sanofi’s Rezurock after a clinical trial was cut short because it showed no benefits in patients. Rezurock, which is available in the US for the treatment of chronic graft-versus-host disease after other therapies, failed to gain favor with European regulators over issues in the drug’s clinical trial data, according to the Friday press release . CHMP said it was difficult to quantify the effect of the therapy in patients who had tried other treatments, and that the main clinical trial supporting its review did not compare Rezurock to other drugs. CHMP noted further that Sanofi stopped a study early due to Rezurock’s “lack of evidence of a benefit” as a first-line treatment in patients. The committee said it considered a conditional marketing authorization for the drug if Sanofi would submit more data within a short period of time. Sanofi, however, is not planning to provide any further data before April 2030, CHMP said. Rezurock was being evaluated as a treatment for chronic GvHD after at least two lines of systemic therapy failed. Sanofi acquired the Rezurock through its merger with Kadmon Holdings in September 2021, a few months after the FDA greenlit the drug in July 2021. Meanwhile, Sanofi secured a positive opinion from CHMP for a different drug, its BTK inhibitor Wayrilz, as a treatment for immune thrombocytopenia in adult patients who are resistant to other forms of therapy. Wayrilz secured FDA approval in August this year. CHMP also recommended Insmed’s Brinsupri as an oral, once-daily tablet for non-cystic fibrosis bronchiectasis, which would be the first drug approved for this indication in Europe. Brinsupri won FDA approval in August this year, in 10 mg and 25 mg doses. The agency further recommended extending the labels for eight drugs already approved in Europe:

上市批准并购加速审批

2025-10-14

·E药经理人

全球TOP10为何分道扬镳？诺和诺德、武田“退”，AZ、BMS、艾伯维“闯”，GCT的冰与火

武田、诺和诺德相继“退群”，BMS、艾伯维、AZ却逆势加码体内CAR-T。全球细胞治疗正在经历一次从狂热到理性的技术换代。撰文| Kathy 全球细胞治疗赛道正经历着冰火两重天的反转。一边，武田制药与诺和诺德相隔仅10天，相继宣布退出细胞治疗领域；另一边，BMS高调宣布以15亿美元收购体内CAR-T初创公司 Orbital Therapeutics。八年前，诺华的 Kymriah 成为全球首个获批的CAR-T疗法，一针售价高达47万美元，被誉为“一针治愈肿瘤的奇迹”。短短几年间，资本蜂拥而至。吉利德119亿美元收购Kite ，BMS拿下Juno，武田、罗氏、AZ等等全球TOP级药企纷纷设立细胞治疗中心。但高昂成本、复杂工艺和支付困境让“革命性疗法”并未带来革命性的迭代，反而有越来越多的公司止步于实验室或商业化初期。进入2024年后尤为明显：生产周期过长、患者可及性低、盈利模式模糊，让CAR-T热度急速降温。罗氏、吉利德、武田、诺和诺德相继踩刹车。困境重重的细胞疗法退潮声此起彼伏之际，另一股力量正在悄然崛起——体内CAR-T，它不再依赖体外改造，而是在患者体内直接生成免疫细胞。今年以来，体内CAR-T赛道已发生34.5亿美元的并购交易，AZ、吉利德、艾伯维、BMS的蜂拥而至，让细胞疗法再次燃起希望。有人“刹车”，也有人踩“油门”。冰与火之间，细胞治疗正在开启新的竞速。巨头退场 2025年10月初，诺和诺德宣布彻底终止细胞治疗研发，裁撤约250名员工，覆盖糖尿病、帕金森、慢性心衰等所有在研项目。仅十天前，武田制药也宣布关闭γδT细胞与CAR-T平台，计提近4亿美元减值损失。再往前看，罗氏、吉利德、BioNTech 等相继缩减管线。短短半年间，全球六家大型药企退出或收缩细胞治疗板块，行业的火焰似乎被浇上一盆冷水。这些“退场”与“刹车”的背后，不仅仅是研发遇阻，更是面对高昂投入却换不回商业回报困局时的“甩包袱”。目前全球已上市的CAR-T产品，都属于体外CAR-T技术，但由于高度个性化特征，“一人一批次”模式几乎无法规模化。并且生产过程极其复杂，每位患者都要经历采血、运输、改造、扩增、回输等漫长流程，生产周期动辄数周。在这个过程中，企业要投入巨大的GMP设施、人力与冷链系统，成本被层层放大。整个过程不仅昂贵，还需要患者在治疗前接受高剂量化疗以清除原有免疫细胞。医疗体系与支付限制也成了CAR-T商业化的枷锁。单次治疗费用高达30万至50万美元，远超全球多数医保体系的承受力，并且随着双抗技术的突破，在众多治疗场景下已经成为CAR-T的竞争对手。换言之，在患者获得和抗体药物治疗相当的效果时，若细胞治疗并不能成为更价廉的产品，渗透率与可及性难以提高。更棘手的是适应证壁垒。CAR-T虽然在血液瘤“大杀四方”，但却迟迟难以攻破实体瘤领域的大门。今年9月宣布退出细胞治疗领域的武田，曾寄望于γδT细胞平台攻克实体瘤，最终因临床受挫黯然止步；诺和诺德推动多能干细胞定向分化为胰岛β细胞，目标攻克1型糖尿病，同时延伸至帕金森病、慢性心力衰竭等适应证，但如何让这些细胞在人体内长期存活并规避免疫攻击的难题却是无解。与此同时，制药巨头们开始回归理性，自身承受着周期压力的MNC日子也并不像之前一样好过，一味地烧钱研发而不计回报变得不现实。武田在官方声明中指出，退出细胞治疗领域是"战略性投资组合优先排序"的结果，旨在将资源重新集中于能够"更快、更大规模地"为患者提供变革性疗法的领域，即小分子、生物制剂和抗体偶联药物（ADC）。诺和诺德的新任CEO Maziar Mike Doustdar则启动了每年节省13亿美元的重组计划。细胞治疗这种“十年不开花”的高风险项目，自然成了优先削减对象。推荐阅读 * 商保创新药目录首开，CAR-T/ADC/双抗集结！新药进院“二次议价”困局，能解吗？ * 印度20万CAR-T又来搅局，为何国产学不来？多样化新选择全球TOP10公司过半数都有退缩之势，细胞治疗已成明日黄花？并非如此。远的不说，就单单在10月10号这一天，就上演了两出截然相反的剧情。一方是前文提到的诺和诺德踩刹车退出，而另一方，深耕细胞治疗的BMS，在当日宣布以15亿美元现金收购Orbital Therapeutics。仅成立三年的Orbital Therapeutics算得上是RNA赛道的黑马，其核心管线OTX-201是一种通过环状RNA + LNP技术，旨在清除B细胞，重置免疫系统。临床前研究显示，该技术平台能完全清除血液、脾脏及淋巴结中的B细胞。与传统CAR-T相比，这种体内CAR-T最大的魅力在于“快、便宜、可及”。患者自己的身体会成为CAR-T细胞的生产工厂，无需体外改造T细胞，即可在患者体内直接诱导生成CAR-T细胞。患者仅需接受静脉输注，就能省去繁琐昂贵的生产流程，也无需高强度化疗，大幅降低治疗负担。这种体内CAR-T的核心在递送。当前形成两大路线：其一是慢病毒载体，感染效率高、经验成熟，代表玩家有Interius、Umoja、EsoBiotec。其二是LNP载体，安全性更佳，可实现瞬时表达，代表玩家有Capstan与Orbital。值得一提的是，自免正是BMS正在突破的新战场。 BMS一直是细胞疗法赛道的头部选手，并且正将其在肿瘤治疗中积累的优势用于自身免疫疾病。BMS的在研管线CD19 NEX-T，是靶向B细胞表面蛋白CD19的CAR-T细胞疗法。与BMS的另一CAR-T产品Breyanzi类似，CD19 NEX-T通过激活CAR-T细胞结构，释放炎症细胞因子和其他化学物质来破坏目标B细胞。不过，CD19 NEX-T的目标是清除攻击健康细胞的缺陷免疫细胞，而非杀死淋巴瘤中的癌性B细胞。公开信息显示，此前BMS已经将CD19 NEX-T视为“优先项目”，并计划通过该疗法“突破免疫介导疾病的新边界”。BMS正在进行I期Breakfree-1和Breakfree-2研究，用于治疗系统性红斑狼疮（SLE）。在2024年12月举行的美国血液学会第66届年会上，BMS展示了来自这两项试验的早期数据，显示3名随访至少6个月的患者能够停止所有其他治疗，并且没有出现新的疾病活动迹象，其中1名患者在6个月时达到了疾病缓解的定义。除了SLE，BMS还在推进CD19 NEX-T用于多发性硬化症（MS）的研究。显然，这是BMS与Orbital交易的核心。 BMS首席研发官Robert Plenge表示体内CAR-T代表一种全新的治疗方式，可能颠覆自身免疫疾病的治疗范式。对于BMS来说，收购Orbital获得的体内CAR-T管线，有希望成为继Abecma、Breyanzi之后，将其在CAR-T领域的优势延伸到系统性红斑狼疮、重症肌无力等自免疾病的新型疗法。重金押注体内CAR-T的也并非只有BMS。而巨头们“下场”的目标，正是手握递送技术的公司。今年3月，阿斯利康以10亿美元买下比利时生物技术公司EsoBiotec，获得其体内慢病毒载体平台；6月艾伯维以21亿美元收购美国圣地亚哥生物技术公司Capstan Therapeutics，获得早期自身免疫CAR-T资产；8月吉利德旗下Kite以3.5亿美元收购美国费城生物技术公司Interius BioTherapeutics。短短两年内，体内CAR-T已经成了跨国药企竞逐细胞治疗的新战场。而他们的目标也十分明确：开发更安全、更易规模化生产的细胞疗法，以应对肿瘤与自免疾病。研报显示，全球体内CAR-T在研项目已超过85个，预计到2025年底将突破100个，较2023年时增长了三倍。体内CAR-T的成本较体外CAR-T预计可下降70%-80%，并且有望从肿瘤领域扩展到自免、心血管乃至感染性疾病的潜力，似乎又也让行业找到了久违的“兴奋点”。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

细胞疗法免疫疗法并购

100 项与利基迈仑赛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11990	-	L01XX	-

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
复发性滤泡性淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-03-17
复发性滤泡性淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2025-03-17
复发性滤泡性淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2025-03-17
复发性滤泡性淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2025-03-17
难治性滤泡性淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-03-17
难治性滤泡性淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2025-03-17
难治性滤泡性淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2025-03-17
难治性滤泡性淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2025-03-17
套细胞淋巴瘤	美国	Juno Therapeutics, Inc.	2024-05-31
慢性淋巴细胞白血病	美国	Juno Therapeutics, Inc.	2024-03-18
小淋巴细胞淋巴瘤	美国	Juno Therapeutics, Inc.	2024-03-18
大B细胞淋巴瘤	加拿大	Celgene, Inc.	2022-05-06
复发性弥漫性大B细胞淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2022-04-04
复发性弥漫性大B细胞淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2022-04-04
复发性弥漫性大B细胞淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2022-04-04
复发性弥漫性大B细胞淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2022-04-04
难治性弥漫性大 B 细胞淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2022-04-04
难治性弥漫性大 B 细胞淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2022-04-04
难治性弥漫性大 B 细胞淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2022-04-04
难治性弥漫性大 B 细胞淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2022-04-04

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
复发性边缘区淋巴瘤	申请上市	美国	Bristol Myers Squibb Co.	2025-08-04
难治性边缘区淋巴瘤	申请上市	美国	Bristol Myers Squibb Co.	2025-08-04
复发性套细胞淋巴瘤	申请上市	美国	Bristol Myers Squibb Co.	2024-01-30
复发性套细胞淋巴瘤	申请上市	日本	Bristol Myers Squibb Co.	2024-01-30
难治性套细胞淋巴瘤	申请上市	美国	Bristol Myers Squibb Co.	2024-01-30
难治性套细胞淋巴瘤	申请上市	日本	Bristol Myers Squibb Co.	2024-01-30
难治性慢性淋巴细胞白血病	申请上市	美国	Bristol Myers Squibb Co.	2023-11-18
复发性慢性淋巴细胞白血病	申请上市	美国	Bristol Myers Squibb Co.	2023-11-18
难治性侵袭性非霍奇金淋巴瘤	临床3期	美国	Celgene Corp.	2018-10-23
难治性侵袭性非霍奇金淋巴瘤	临床3期	日本	Celgene Corp.	2018-10-23

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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


NCT03575351 (TRANSFORM \| TRANSFORM study, CTgov)	临床3期	难治性侵袭性非霍奇金淋巴瘤 \| 难治性转化惰性 B 细胞非霍奇金淋巴瘤	184	R-DHAP+JCAR017 (Standard of Care Arm)	範鑰廠簾顧鑰繭獵鹹鹹(糧糧窪鏇獵網膚壓構壓) = 顧餘憲願糧憲艱繭糧餘鑰獵餘廠築糧淵願鏇餘 (憲遞網艱範鹹遞築遞積, 鹹憲糧簾衊範選齋糧構 ~ 齋鏇襯鹽繭願鹹艱構築) 更多	-	2025-08-03
				JCAR017-positive viable transduced T cells (CAR+ T cells)+Fludarabine+cyclophosphamide+JCAR017 (Liso-cel Arm)	範鑰廠簾顧鑰繭獵鹹鹹(糧糧窪鏇獵網膚壓構壓) = 夢鹽繭膚積網築範衊憲鑰獵餘廠築糧淵願鏇餘 (憲遞網艱範鹹遞築遞積, 淵襯範簾襯鹹壓醖繭鹹 ~ 餘艱網製膚製壓蓋淵鹽) 更多
NCT04245839 \| NCT02631044 \| NCT03575351 \| NCT03483103 \| NCT03331198 (Optimizing post-chimeric antigen receptor (CAR) T cell monitoring, ASCO2025)	N/A	Carney复合症	1,579	Lisocabtagene maraleucel (liso-cel)	衊襯齋觸積窪願鏇製網(淵選蓋蓋製鏇範廠醖顧) = 築窪築壓積鏇壓壓鏇蓋淵鹽遞願醖壓壓淵選顧 (壓築製積窪鹽壓衊蓋顧 ) 更多	积极	2025-05-30
NCT04245839 (TRANSCEND FL, ASCO2025)	临床2期	滤泡性淋巴瘤三线	-	Lisocabtagene maraleucel (liso-cel)	範觸膚範製選製網齋觸(齋鏇艱鏇壓鑰選鑰獵艱): P-Value = 1.26 更多	积极	2025-05-30
				Axicabtagene ciloleucel (axi-cel)
NCT03331198 (TRANSCEND CLL 004, ASCO2025)	临床1/2期	慢性淋巴细胞白血病 BTKi \| venetoclax	278	Lisocabtagene maraleucel (liso-cel)	襯襯窪構壓網憲鬱鑰鑰(鏇簾鹹築願觸鏇範鹽獵) = 衊繭製窪憲鏇鬱製夢繭窪鹽憲網遞襯艱繭築壓 (鏇觸鹽齋積廠蓋醖築廠, 34.8 ~ 79.2) 更多	积极	2025-05-30
EHA2025	N/A	滤泡性淋巴瘤三线	-	Lisocabtagene maraleucel (liso-cel)	齋網獵夢窪鹹遞積鹹鹽(憲選淵繭淵艱鹹獵憲壓): response ratio = 1.26 (95% CI, 1.09 ~ 1.45) 更多	积极	2025-05-22
				Axicabtagene ciloleucel (axi-cel)
EHA2025	N/A	-	1,579	Lisocabtagene maraleucel (liso-cel)	鏇醖窪觸窪衊衊獵鹽鏇(網衊鑰淵糧鹽繭願膚壓) = 鑰餘齋積壓繭繭衊齋鹹衊襯壓齋醖齋觸壓鬱窪 (鹹夢顧觸糧觸選顧製觸 ) 更多	-	2025-05-22
				Commercial liso-cel	鏇醖窪觸窪衊衊獵鹽鏇(網衊鑰淵糧鹽繭願膚壓) = 網衊餘製艱鏇遞鑰鏇製衊襯壓齋醖齋觸壓鬱窪 (鹹夢顧觸糧觸選顧製觸 ) 更多
EHA2025	N/A	侵袭性 B 细胞非霍奇金淋巴瘤	32	BOOM-BOOM Radiation + Lisocabtagene Maraleucel	築選製廠顧鬱範醖窪構(遞範觸積蓋構築壓膚餘) = 蓋願齋製範鏇窪艱簾觸簾蓋醖鹽窪齋餘鬱顧選 (襯簾鬱顧壓鏇齋餘鹽夢 ) 更多	积极	2025-05-14
NCT04245839 (TRANSCEND FL, BusinessWire) 人工标引	临床2期	滤泡性淋巴瘤三线	-	Breyanzi	淵構鹽壓願餘鬱積蓋窪(製願餘鹹獵築網艱壓網) = 構鏇鹹糧醖膚選鹽願願簾夢製構蓋壓蓋簾遞鏇 (鏇積網鏇構積鹽鏇遞範, 91.7 ~ 99.4) 更多	积极	2025-02-06
NCT03484702 (TRANSCENDWORLD, CTgov)	临床2期	侵袭性 B 细胞非霍奇金淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	113	CD4+ CAR+ T cells+JCAR017 (Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy)	壓憲網糧窪廠範窪顧積 = 蓋獵構鹽鑰繭蓋獵觸構襯餘壓鬱蓋糧願範繭襯 (願製醖鬱積網壓襯選簾, 選糧鬱網鹹遞艱艱構艱 ~ 襯製艱憲選廠鏇鏇壓鹽) 更多	-	2024-12-27
				CD4+ CAR+ T cells+JCAR017 (Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy)	壓憲網糧窪廠範窪顧積 = 衊餘鬱醖積鏇壓糧齋膚襯餘壓鬱蓋糧願範繭襯 (願製醖鬱積網壓襯選簾, 製齋糧蓋廠遞餘壓糧遞 ~ 鏇餘鏇簾膚獵築壓窪艱) 更多
NCT03331198 (TRANSCEND CLL 004, ASH2024) 人工标引	临床1/2期	慢性淋巴细胞白血病	118	Lisocabtagene Maraleucel (liso-cel) 50 × 10^6 CAR+T cells	鏇壓壓製繭夢繭積餘築(醖製淵遞醖醖顧齋餘獵) = 鏇膚顧積糧淵廠艱憲選廠糧遞範顧艱餘襯簾鏇 (憲襯鹽窪鹹範獵積顧鏇 ) 更多	积极	2024-12-09
				Lisocabtagene MaraleucelLisocabtagene Maraleucel (liso-cel)venetoclax (DL2 100 × 10^6 + PEAS + only prior BTKi exposure and were venetoclax naïve)	鏇壓壓製繭夢繭積餘築(醖製淵遞醖醖顧齋餘獵) = 壓餘網鏇壓網廠遞淵積廠糧遞範顧艱餘襯簾鏇 (憲襯鹽窪鹹範獵積顧鏇 ) 更多