更新于：2024-09-20

Lisocabtagene maraleucel

利基迈仑赛

更新于：2024-09-20

概要

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

+ [6]

靶点

CD19

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

癌症免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症

套细胞淋巴瘤慢性淋巴细胞白血病大B细胞淋巴瘤+ [28]

非在研适应症

前体B细胞急性淋巴细胞白血病复发性 B 细胞急性淋巴细胞白血病

原研机构

Fred Hutchinson Cancer Research Center

Bristol Myers Squibb Co.

在研机构

Celgene Corp.Bristol-Myers Squibb Pharma EEIG

Juno Therapeutics, Inc.

+ [1]

非在研机构-

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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序列信息

Sequence Code 133531

来源: *****

Sequence Code 133534

来源: *****

Sequence Code 133555

来源: *****

Sequence Code 133567

来源: *****

Sequence Code 133586

来源: *****

Sequence Code 171111

来源: *****

关联

项与利基迈仑赛相关的临床试验

NCT06313996 / Not yet recruiting临床3期

A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)

The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.

开始日期2024-03-29

申办/合作机构

Juno Therapeutics, Inc.

[+1]

NCT06205290 / Withdrawn临床3期

A Global Phase 3, Randomized, Open-label, Multi-center Trial Designed to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options (Idelalisib + Rituximab or Bendamustine + Rituximab) in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Whose Disease Has Failed Treatment With Both BTKi and BCL2i Targeted Therapies (A Double Class Exposed Population)

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.

开始日期2024-01-16

申办/合作机构

Juno Therapeutics, Inc.

[+1]

NCT05934448 / Recruiting临床2期IIT

A Phase II Trial of Pembrolizumab in Combination With Chimeric Antigen Receptor Therapy in Patients With Relapsed/Refractory Primary Mediastinal B-cell Lymphoma

This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment.
The names of the study drugs involved in this study are:
- Pembrolizumab
Standard treatment will include:
CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel)
Cyclophosphamide
Fludarabine

开始日期2023-11-15

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+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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110

项与利基迈仑赛相关的文献（医药）

2024-04-01·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma: Primary Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study

Article

作者: Palomba, M Lia ; Kostic, Ana ; Andreadis, Charalambos ; Abramson, Jeremy S ; Wang, Michael ; Peng, Lily ; Ghosh, Nilanjan ; Gordon, Leo I ; Lunning, Matthew ; Hirayama, Alexandre V ; Espinola, Ricardo ; Arnason, Jon ; Dehner, Christine ; Kamdar, Manali ; Chattin, Amy ; Ogasawara, Ken ; Solomon, Scott R ; Mehta, Amitkumar ; Siddiqi, Tanya ; Eliason, Laurie

PURPOSE:

To report the primary analysis results from the mantle cell lymphoma (MCL) cohort of the phase I seamless design TRANSCEND NHL 001 (ClinicalTrials.gov identifier: NCT02631044 ) study.

METHODS:

Patients with relapsed/refractory (R/R) MCL after ≥two lines of previous therapy, including a Bruton tyrosine kinase inhibitor (BTKi), an alkylating agent, and a CD20-targeted agent, received lisocabtagene maraleucel (liso-cel) at a target dose level (DL) of 50 × 106 (DL1) or 100 × 106 (DL2) chimeric antigen receptor-positive T cells. Primary end points were adverse events (AEs), dose-limiting toxicities, and objective response rate (ORR) by independent review committee per Lugano criteria.

RESULTS:

Of 104 leukapheresed patients, liso-cel was infused into 88. Median (range) number of previous lines of therapy was three (1-11) with 30% receiving ≥five previous lines of therapy, 73% of patients were age 65 years and older, 69% had refractory disease, 53% had BTKi refractory disease, 23% had TP53 mutation, and 8% had secondary CNS lymphoma. Median (range) on-study follow-up was 16.1 months (0.4-60.5). In the efficacy set (n = 83; DL1 + DL2), ORR was 83.1% (95% CI, 73.3 to 90.5) and complete response (CR) rate was 72.3% (95% CI, 61.4 to 81.6). Median duration of response was 15.7 months (95% CI, 6.2 to 24.0) and progression-free survival was 15.3 months (95% CI, 6.6 to 24.9). Most common grade ≥3 treatment-emergent AEs were neutropenia (56%), anemia (37.5%), and thrombocytopenia (25%). Cytokine release syndrome (CRS) was reported in 61% of patients (grade 3/4, 1%; grade 5, 0), neurologic events (NEs) in 31% (grade 3/4, 9%; grade 5, 0), grade ≥3 infections in 15%, and prolonged cytopenia in 40%.

CONCLUSION:

Liso-cel demonstrated high CR rate and deep, durable responses with low incidence of grade ≥3 CRS, NE, and infections in patients with heavily pretreated R/R MCL, including those with high-risk, aggressive disease.

2024-02-01·Blood

Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001

Article

作者: Kostic, Ana ; Maloney, David G ; Purev, Enkhtsetseg ; Sehgal, Alison ; Arnason, Jon ; Wang, Michael ; Abramson, Jeremy S ; Dehner, Christine ; Gordon, Leo I ; Andreadis, Charalambos ; Ghosh, Nilanjan ; Lunning, Matthew ; Kim, Yeonhee ; Palomba, M Lia ; Ogasawara, Ken ; Siddiqi, Tanya ; Solomon, Scott R

Abstract:

Lisocabtagene maraleucel (liso-cel) demonstrated significant efficacy with a manageable safety profile as third-line or later treatment for patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in the TRANSCEND NHL 001 study. Primary end points were adverse events (AEs), dose-limiting toxicities, and objective response rate (ORR) per independent review committee. Key secondary end points were complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), and overall survival (OS). After 2-year follow-up, patients could enroll in a separate study assessing long-term (≤15 years) safety and OS. Liso-cel–treated patients (N = 270) had a median age of 63 years (range, 18-86 years) and a median of 3 prior lines (range, 1-8) of systemic therapy, and 181 of them (67%) had chemotherapy-refractory LBCL. Median follow-up was 19.9 months. In efficacy-evaluable patients (N = 257), the ORR was 73% and CR rate was 53%. The median (95% confidence interval) DOR, PFS, and OS were 23.1 (8.6 to not reached), 6.8 (3.3-12.7), and 27.3 months (16.2-45.6), respectively. Estimated 2-year DOR, PFS, and OS rates were 49.5%, 40.6%, and 50.5%, respectively. In the 90-day treatment-emergent period (N = 270), grade 3 to 4 cytokine release syndrome and neurological events occurred in 2% and 10% of patients, respectively. The most common grade ≥3 AEs in treatment-emergent and posttreatment-emergent periods, respectively, were neutropenia (60% and 7%) and anemia (37% and 6%). Liso-cel demonstrated durable remissions and a manageable safety profile with no new safety signals during the 2-year follow-up in patients with R/R LBCL. These trials were registered at www.ClinicalTrials.gov as #NCT02631044 and #NCT03435796.

2024-01-23·Blood advances

Cost-effectiveness of second-line lisocabtagene maraleucel in relapsed or refractory diffuse large B-cell lymphoma

Article

作者: Choe, Jee H ; Abramson, Jeremy S ; Yu, Tianzhou ; Abou-El-Enein, Mohamed

Abstract:

Lisocabtagene maraleucel (liso-cel), a chimeric antigen receptor (CAR) T-cell therapy, received the US Food and Drug Administration approval in 2022 for second-line treatment of diffuse large B-cell lymphoma (DLBCL) for patients with refractory disease or early relapse after first-line chemoimmunotherapy. This decision was based on the TRANSFORM study demonstrating improvements in event-free survival with liso-cel compared with standard care. Given the high costs of CAR T-cell therapies, particularly as they transition to second-line treatment, a cost-effectiveness analysis is essential to determine their economic viability. The study used a partitioned survival model with standard parametric functions to evaluate the cost-effectiveness of liso-cel aganist platinum-based chemotherapy followed by high-dose chemotherapy and autologous hematopoietic stem cell transplantation over a lifetime horizon The analysis relied on data from the TRANSFORM and TRANSCEND trials, established literature, and public data sets to calculate the incremental cost-effectiveness ratio (ICER). For a representative cohort of US adults aged 60 years, ICER of liso-cel was $99 669 per quality-adjusted life-year (QALY) from a health care sector perspective and $68 212 per QALY from a societal perspective, confirming its cost-effectiveness at the $100 000 per QALY threshold. Nonetheless, under certain scenarios, liso-cel surpasses this benchmark but remains within the US acceptable range of $150 000 per QALY. A key finding underlines the importance of incorporating productivity losses into such analyses to capture the broader societal values of novel therapies. Although these therapies offer substantial clinical benefits, their high acquisition costs and limited long-term data critically challenge their economic sustainability.

485

项与利基迈仑赛相关的新闻（医药）

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·博腾生物

深圳站开启！细胞与基因治疗产品开发及注册申报案例分享会

2024年，基因与细胞治疗行业在全球范围内持续快速发展，尤其在药物研发、产品上市以及细胞治疗产品的获批IND方面取得了显著进展。中国在这一领域的进步尤为显著，不仅在技术研发上取得了突破，在政策监管和市场准入方面也逐步完善。目前，中国已有多款CGT疗法获批上市，包括科济药业的泽沃基奥仑赛注射液（商品名：赛恺泽），这是中国上市的第五款CAR-T细胞治疗药品，用于治疗复发或难治性多发性骨髓瘤成人患者。此外，全球首款用于治疗不可切除或转移性黑色素瘤的肿瘤浸润淋巴细胞疗法Amtagvi，以及用于治疗复发/难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤的Breyanzi也获得了FDA批准。据统计，2024年第一季度，国内细胞治疗领域共有44款细胞疗法取得临床申报进展，包括28款免疫细胞疗法和16款干细胞疗法。CDE共有28项IND获得受理，16项获批IND即将进入临床，整体申报/获批数量相较于去年第一季度增加近20%。此外，2024年上半年，国内约有70款CGT疗法IND获批，涵盖了多种新型免疫细胞疗法，如TIL、TCR-T、NK等，显示了细胞与基因治疗领域的快速发展和活跃。 CGT领域的监管政策也在不断完善。从早期的审批制到如今的备案制，中国政府在推动CGT行业发展的同时，也在加强安全性和有效性的监管，以确保患者的福祉和行业的健康发展。为加强CGT领域各方的交流与合作，博腾生物携合作伙伴发起的《细胞与基因治疗产品开发及注册申报案例分享会》将走进重点生物医药产业园，围绕研发、生产和注册申报等不同环节进行案例分析和讨论。备受期待的深圳站将于2024年10月16日举办，届时将有多位行业专家代表出席，就细胞治疗药物从IIT、IND到临床阶段的全流程展开分享。讨论议题法规政策：分享细胞治疗产品相关指导原则，包括产品的质量管理、临床前研究、临床试验、制造工艺和生产控制方面的监管要求；深入解读当前CGT领域的法规政策，特别是在临床期间变更过程中遇到的法规要求和实际操作挑战，如变更管理的关键原则和策略，药物安全性、有效性、质量控制、风险评估以及变更的可比性研究等。技术研究：探讨ddPCR技术如何在细胞基因治疗中应对质量控制挑战，保证药物开发中基因表达分析数据的准确性和连贯性。 CMC策略：分享不同病毒载体（AdV/AAV/LVV）的CMC策略，包括载体选择和设计、生产工艺开发、质量控制与验证以及监管合规，在生产工艺的稳健性、质量一致性等方面深入探讨。探讨iPSC的制备关键技术，如科研级和临床级iPSC细胞库的建立及功能细胞定向分化技术，以及 iPSC在细胞治疗药物开发中的具体应用实例和进展。临床开发：围绕安全性与有效性评估、临床试验设计与执行、患者招募与管理、法规与伦理要求等方面，详细讨论在临床开发过程中需重点关注和解决的问题。活动信息活动主题：细胞治疗产品开发及注册申报案例分享会主办单位：博腾生物、赛赋医药深圳中心协办单位：深圳霁因生物医药转化研究院、银星科技园、深圳市生命科学与生物技术协会、深圳市细胞治疗技术协会支持单位：伯乐生命科学、三卿生物、恺佧生物、普瑞盛医药、细胞科技网、品合医学活动时间：2024年10月16日活动地点：深圳霁因生物医药转化研究院311会议厅（深圳市龙华区观光路1301-76号银星智界二期1号楼B座）活动报名扫描上方二维码参与报名活动日程 1 12:30-13:00 签到 2 13:00-13:10 IND药物申报一体化服务，助力细胞疗法开发陈晖博腾生物首席财务官 3 13:10-13:50 细胞治疗产品相关指导原则要求及案例分析韦娜国科赛赋（深圳）总经理 4 13:50-14:30 不同病毒载体(AdV/AAV/LVV)的CMC策略及关注要点段磊博腾生物病毒负责人 5 14:30-15:10 细胞治疗药物临床期间变更相关法规及案例分享李丹三卿生物创始人 6 15:10-15:50 精确追踪与定量：ddPCR在CGT分子分析中的应用吴玉娴伯乐大客户经理 7 15:50-16:00 参观深圳霁因生物医药转化研究院 8 16:00-16:10 茶歇 9 16:10-16:50 iPSC的发展、应用现状及制备关键技术许建坡博腾生物细胞研发部总监 10 16:50-17:30 细胞与基因治疗药物临床开发过程中的关注点周建国普瑞盛高级医学总监 11 17:30-18:10 EuLV慢病毒生产系统：慢病毒载体生产的新时代刘斌深研生物CMO 12 18:10-18:40 自由讨论扫描右侧二维码进入社群细胞治疗产品案例分享会【深圳站】嘉宾简介陈晖博腾生物首席财务官陈晖拥有多年CDMO和制药行业的工作经验，曾任职于英特尔、药明康德等头部企业，现任博腾股份副总经理、首席财务官、博腾生物CFO。韦娜国科赛赋（深圳）总经理国科赛赋深圳新药研发科技有限公司总经理/机构负责人，中国环境诱变剂学会致突变专业委员会秘书长、中国毒理学会中药与天然药物毒理专业委员会委员、生殖毒理/遗传毒理专业委员会委员。许建坡博腾生物细胞研发部总监生物学博士&博士后，超过7年的干细胞治疗、PBMC分化的巨噬细胞（pMac)以及iPSC分化的巨噬细胞(iMac)治疗的技术平台研发、工艺转化经验，曾就职于江苏普瑞康、赛元生物等公司，负责细胞治疗药物研发、工艺开发及项目管理工作。李丹三卿生物联合创始人创办三卿（北京）生物科技有限公司，作为主要技术负责人，带领团队深度参与多项CAR-T等细胞与基因治疗药物的药学（CMC）、质量控制、非临床等全流程的项目管理和注册申报工作，协助多个创新药客户获得临床批件，在创新药全流程项目管理及快速产业转化方面具有丰富的经验。同时带领团队建立药品成药性评价、生物样本分析、质控方法开发三大技术外包服务平台，旨在将“科学及法规”相结合，为客户提供深入化的“新药转化与分析检测服务”，协助客户快速实现创新药转化。段磊博腾生物病毒研发开发和生产副总经理近14年生物制药行业CMC工艺开发、生产工艺放大和转移、分析方法开发、QC和GMP 生产和质量保证管理工作经验、药物CMC技术管理和项目管理经验、具有多种生物药（病毒载体AdV、AAV、LVV、mRNA-LNP体内基因治疗药物、预防性病毒和细菌疫苗）的成功 IND 及 NDA经验（5年内）；具备预防用生物制品或生物药生产线设计经验、GMP 认证经验、注册生产现场检查、研发生产设施运营经验，丰富的IND和NDA注册申报资料撰写、CMC申报策略制定、CMC变更及发补问题回答的丰富经验。梅彦伯乐公司应用技术专家华南农业大学动物遗传育种硕士，从事CRISPR-Cas13系统与动物病毒相关研究工作。现任Bio-Rad生命科学部南区应用专家。5年以上数字PCR领域支持经验，致力于为Bio-Rad的科研、工业和医学客户提供数字PCR应用开发、试验设计和数据分析等一站式完整解决方案。周建国普瑞盛高级医学总监目前在普瑞盛北京医药担任医学法规注册中心负责人，整体负责新药上市前研发，注册，药物警戒以及上市后研究等事务。加入普瑞盛之前，曾在法国益普生制药公司担任中国区医学负责人，负责肿瘤和罕见病领域包括曲谱瑞林，兰瑞肽和卡博替尼的临床医学开发策略制定，新产品临床研究，上市前准备，医学活动和患者项目的管理工作。在此之前，曾在比利时体外诊断和精准医学公司Biocartis担任医学市场部的负责人，负责肺癌、结直肠癌和黑色素瘤领域产品上市前注册和科研等工作，同时负责产品的市场推广，外资药企战略合作和市场等工作。在此之前，曾在西安杨森工作7年，先后担任免疫领域医学顾问，团队负责人，医学教育和医学顾问团队的负责人和治疗领域负责人。曾参与英夫利西单抗（Remicade），戈里木单抗(Simponi)，乌司奴单抗(Stelara)，IL-17, IL-6单克隆抗体在风湿、消化和皮肤领域等新药立项评估，医学支持，临床研究，上市前准备，以及上市后中青年医学培养和国际合作项目，以及风险管理计划制定等全流程的医学工作。2014年作为强生医学核心人才参与医学团队中国区胜任力模型的制定以及作为医学顾问到台湾强生进行轮岗，指导和协助医学团队的支持和管理工作。刘斌深研生物CMO 毕业于香港科技大学，深耕生命科学领域16余年，曾参与并助力细胞与基因治疗（CGT）药物的研发及IND申报，在商务拓展、项目管理、产品研发、cGMP、IND申报等方面具备丰富的经验。现负责深研生物的CGT技术及产品的研发策略、市场策略的制定，并开展全球化的商务合作事项。扫描上方二维码参与报名关于博腾生物苏州博腾生物制药有限公司成立于2018 年12月，立足于苏州工业园区，以上市公司-重庆博腾制药科技股份有限公司（股票代码：300363）为依托，搭建了质粒、病毒载体、细胞治疗、基因治疗、核酸疗法等CRO和CDMO平台，提供从科研包装，建库，工艺开发，分析方法开发，cGMP生产到制剂灌装的端到端服务，贯穿药物的不同研发阶段，帮助客户加快药物研发与上市进程。博腾生物聚焦基因与细胞治疗，在博腾股份的成功经验之上，以国际一流的专业人才为核心，秉承“客户第一”的服务宗旨，以“合规、专业、专注、开放协作”为品牌理念，延续母公司强大的IP保护和项目管理机制以及完善的质量管理体系，充分利用核心团队将基因和细胞治疗产品推向临床直至上市的成功经验，为全球客户提供优质和高效的服务，让好药更早惠及大众。

细胞疗法临床申请基因疗法免疫疗法上市批准

2024-09-17

·同写意

他山之石：日本细胞疗法的十年

作为生物制药的一大前沿，细胞疗法越来越受业界重视，也成为不少国家抢占的高地，日本就是这样的代表。 2012年，因发现诱导多能干细胞（iPSC）技术，日本京都大学教授山中伸弥获得诺贝尔奖。此后，日本政府开始积极在细胞治疗领域布局。通过建立《再生医学促进法》《再生医学安全法》等特殊法规监管途径，十多年来，日本不遗余力地鼓励细胞疗法的开发和商业化，批准了许多产品。它们大部分是由日本公司推出的，但也包括来自欧美MNC的CAR-T疗法。然而，由于某些产品的疗效缺乏可预测性，日本近期修改了该领域的法规，谨慎地缩小附条件批准范围，降低价格补贴。商业探索喜忧参半，一些细胞产品已退出日本市场。对于其他国家，能从日本的处境看到多少自己的影子？ 1 18种获批细胞疗法到目前为止，日本已经批准了18种细胞疗法，包括两款基于附条件批准框架的产品。适应症分布上，用于治疗血液瘤的产品最多，共计6种。在神经、眼科、骨科等其他疾病领域，也都有疗法覆盖。从地域看，12种疗法来自日本，占比近七成。其中，光是J-TEC就推出5种。2015年之前，J-TEC的Jace（自体培养表皮）和Jacc（自体培养软骨）是日本仅有的两款获批细胞产品。改变日本细胞疗法产业环境的关键之年是2012年，山中伸弥因相关研究获得诺贝尔奖。此后，被视为具有广阔前景的iPSC领域，也开始受到日本政府层面的支持。很多适应症都是在那之后获得批准的。最近一款上市产品，是由日本公司SanBio开发的同种异体间充质干细胞疗法Akuugo，用于改善与创伤性脑损伤相关的慢性运动性麻痹。7月底，Akuugo首次获得附条件批准。 2 安倍“十年战略” 2013年，时任日本首相安倍晋三在其经济政策中指出，政府应牵头推动创新医疗研发的全国性举措，并承诺到2022年这10年间，投资1100亿日元（约合7.53亿美元）支持再生医学发展。到2014年，安倍政府通过内阁府推动《健康医疗战略推进法》出台，并于2015年成立了专门负责协调和支持国内药物研发项目（不仅仅是细胞疗法）的日本医学研究开发机构（AMED）。 AMED旨在通过横跨厚生劳动省（MHLW）、经济产业省（METI）以及文部科学省（MEXT）三个部门，架起政府、公司和学术机构的桥梁。从2015年到2020年，AMED每年提供约140亿到160亿日元（约合0.97亿到1.11亿美元）用于支持国内药物研发，其中近一半（65亿日元）用于iPSC领域。 3 附条件批准框架大约在安倍政府提供资金支持的同一时间，日本颁布了《再生医学促进法》，对《药品和医疗器械法案》进行修订，引入细胞和基因疗法等再生医学产品的附条件批准框架。改革前，小分子药物等疗法必须经过昂贵且繁琐的三个阶段临床试验，才能获得日本药品和医疗器械管理局（PMDA）的批准。为了缩短上市时间，该方案允许在若干条件下，提前批准已证实安全性和具备“潜在”疗效的疗法。之后，这些产品需要开展上市后的试验以确认疗效，并在附条件批准期内提交申请以获得全面批准。 Nature刊登的一篇文章介绍，基于这个框架，再生医学疗法开发商将不必按照阶段推进临床，而是在一项试验研究中证明疗效。如果变化足够显著，则一次试验中至少要有10名患者；如果改善幅度较小，则要有几百名患者。 2014年11月，PMDA在一份解释性文件中表示，对iPSC相关产品的高期望和解决潜在安全风险的监管方法是该方案的关键。从2017年开始，附条件批准框架扩大到包括非再生创新药物。 4 分化的商业市场得益于这些转变，监管部门自2015年以来越来越频繁地对细胞和基因疗法产品点头。然而，日本也不得不的面临随之而来的问题，例如，产品附条件批准后的疗效不及预期，日本国民健康保险（NHI）计划中的成本与效益平衡压力。 2015年，JCR Pharmaceuticals申报的同种异体骨髓源间充质干细胞（MSC）产品Temcell、Terumo申报的自体成骨肌源性细胞片产品HeartSheet，分别获得附条件批准。 Temcell基于2003年由Osiris Therapeutics授权的MSC技术开发，被批准用于移植物抗宿主病，这是一种发生在同种异体骨髓移植患者中的严重并发症。Temcell每次治疗价格约为1400万日元，并成为日本最成功的细胞疗法之一，在2023年创造32亿日元（2210万美元）的收入。不过，HeartSheet就没那么幸运了。最初，HeartSheet获得治疗严重心力衰竭的5年有条件批准，但由于其适应症小等诸多限制，后来在上市后试验中招募患者时遇到困难。附条件批准期延长至8年后，Terumo在2023年申请全面批准，但未能证明其有效性。最终，Terumo决定在今年将HeartSheet撤出市场。另一个与之相似的案例，是日本公司Nipro开发的自体骨髓来源MSC产品Stemirac，附条件批准期间从2018年到2025年，用于改善与创伤性脊髓损伤相关的神经症状和功能障碍。自COVID-19以来，Nipro在Stemirac商业化方面受阻。最近该公司表示，它的目标是在2025年申请全面批准，并扩大与医疗机构的合作，以获得收入。 5月，Nipro披露的最新财务报告说：“COVID-19的两年中，由于优先考虑重症患者，对Stemirac的管理一直很困难，其收入未能达到最初的预测。” 5 收窄加速通道附条件批准框架施行十年后，今年3月，MHLW发布一项新指南，以说明如何通过上市后的研究计划来认定细胞疗法的有效性。指南提到，药企和监管机构应事先明确附条件批准后所开展试验的适当性，应涉及病例数、开展试验的地点数、参数的客观性、病例的随机化、评价的盲法、对照组的建立等方面。为此，指南还提出了统计学上可推测有效性的参考基准。 MHLW此举的背景是，2020年到2023年，日本政府根据此前“十年战略”的框架，对未来的创新药品政策进行一系列讨论。 6月，因为附条件批准期限届满，AnGes撤回了日本首款基因疗法Collategene的制造和营销批准申请。随着Collategene、HeartSheet等几款产品证明其疗效的失败，MHLW认为，通过哪种类型的数据，并以怎样的准确性“推测”疗效，成为日本的关键挑战之一。 “重要的是要有某种指导方针来推定有条件批准的效力。”去年，MHLW在就这一问题撰写的最终报告里写道。截至2024年，没有任何附条件批准的细胞治疗产品在日本成功获得全面批准。 6 国家医保“砍价” 日本细胞疗法开发商面临的另一个挑战是，NHI降低了报销价格。有几种产品由于价格昂贵，已根据成本效益评估（CEA）框架进行了审查。 CEA框架自2019年推出，旨在通过增加另一种价格评估选项，来“补充日本的药品定价体系”，帮助维持NHI报销费率内的财务平衡。CEA导致的最大降价幅度为15%。MHLW指出，如果产品在初始定价中获得的溢价低于25%，则降价幅度将限制在10%以内；如果溢价超过25%，则降幅最高不超过15%。数种CAR-T细胞疗法——包括吉利德的Yescarta，BMS的Breyanzi和Abecma，诺华的Kymriah——已在日本获得了报销价格。 MHLW最初通过成本计算方法，在2019年将Kymriah的报销价格定为约3411.37万日元（约合23.43万美元）。这是在诺华的基因疗法Luxturna于2023年登陆日本市场前，在NHI获得的最高价格。 2021年，通过CEA审查，和安进的Blyncito、辉瑞的Besponsa等其他几种疗法进行比较后，MHLW将Kymriah的价格下调了4.3%，至3264.78万日元。该机构指出，Kymriah在首次定价时的生产成本缺乏透明度（低于50%）。 Yescarta、Breyanzi和Abecma预计也将在日本的CEA框架下接受审查。 7 本土尚有后来者尽管监管立场日趋谨慎，日本目前还有其他细胞疗法处于临床开发当中。 Healios K.K.的同种异体骨髓来源的多能祖细胞候选药物HLCM051，目前正处于治疗急性呼吸窘迫综合征的III期研究。1月，在美国开展的另一项治疗缺血性卒中的III期项目中，HLCM051错过了主要终点。另一家专注于CAR-T疗法的日本公司Noile-Immune，旗下NIB101、NIB102已处于I期临床，分别靶向GM2和GPC3。 2023年6月，Noile-Immune在本土IPO，但目前股价跌幅超过70%。 Noile-Immune遭遇了几次挫折，包括终止与武田就NIB102的研发合作。不过，该公司近期表示，它仍将继续推进NIB102。参考资料： 1.Progress Or Hype? Looking At A Decade Of Cell Therapy In Japan；Pink Sheet 2.Japan to offer fast-track approval path for stem cell therapies；Nature 3.医薬品医療機器総合機構（PMDA）のウェブサイト；PMDA 4.BRIEF—Collategene sales rights deal terminated in Japan and the USA；Pharma Letter 5.Japan’s CEA Scheme: How It Works And Impact So Far；Pink Sheet 6.Cell Therapy HLCM051 Fails to Improve Stroke Outcomes Despite Safe Profile；NeurologyLive 同写意媒体矩阵，欢迎关注↓↓↓

细胞疗法上市批准基因疗法免疫疗法

2024-09-16

·PRNewswire

Expanding the Bispecific Antibody Market from CAR-Ts to Drive Follicular Lymphoma's Future | DelveInsight

The competition in follicular lymphoma is rapidly intensifying, with three CAR-T therapies and three bispecific antibodies now approved for relapsed or refractory patients. As both classes of treatments expand, the battle for dominance in this market is growing, with each therapy offering unique advantages in accessibility, efficacy, and safety profiles, setting the stage for a dynamic shift in treatment strategies. LAS VEGAS, Sept. 16, 2024 /PRNewswire/ -- Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) that develops from B-lymphocytes and is generally slow-growing or indolent. This subtype represents 20–30% of all NHL cases. While follicular lymphoma typically progresses slowly, there are instances where it can grow more rapidly. Treatment options for follicular lymphoma include, chemotherapy, radiation therapy, immunotherapy, stem cell transplantation, CAR T-cell therapy, and bispecific-antibodies. For those in the early stages of the disease (Ann Arbor stages I or II), treatment may involve radiation therapy alone or in combination with chemotherapy. Patients with advanced follicular lymphoma are typically treated initially with a combination of chemotherapy and anti-CD20 antibodies, a method known as chemoimmunotherapy. The most commonly used antibodies are RITUXAN (rituximab) and GAZYVA (obinutuzumab), which specifically target tumor cells associated with follicular lymphoma. In older patients who do not have organ dysfunction, treatment with rituximab alone may be an option. Other therapies like ZEVALIN (yttrium-90 ibritumomab tiuxetan), TAZVERIK (tazemetostat), REVLIMID (lenalidomide), and others are approved for the treatment of follicular lymphoma. CAR T-cell therapies are becoming increasingly significant in treating follicular lymphoma. YESCARTA, a CD19-directed genetically modified autologous T-cell therapy, became the first CAR-T to be approved for follicular lymphoma by the US FDA in March 2021. Before the approval of YESCARTA, BREYANZI was approved in February 2021 for Grade 3B follicular lymphoma that accounts for about 5-10% of all follicular lymphoma cases. Later in April 2022 it was approved by the European commission. In May 2024 BREYANZI was approved for the treatment of relapsed/refractory follicular lymphoma who have received two or more prior lines of systemic therapy and provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months. In May 2022, Novartis announced that the European Commission approved KYMRIAH (tisagenlecleucel) for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more systemic therapies. This approval represents the third indication for KYMRIAH, making it the first CAR-T cell therapy sanctioned in Europe for such patients, including those with relapsed/refractory follicular lymphoma Grades 1, 2, and 3A. Additionally, in May 2022, the US FDA granted approval for KYMRIAH for the same patient group. Currently, autologous CAR-T therapies are the only ones approved, but the emerging pipeline predominantly comprises autologous CAR-Ts alongside a growing number of allogeneic CAR-T therapies. Allogeneic CAR-T, a newer term, refers to donor-derived therapies offering several advantages over autologous treatments. These off-the-shelf therapies are readily available, eliminating the need to modify patient cells either at a central manufacturing site or at the point of care. Even though the reimbursement of CAR-T therapies represents a challenge for healthcare providers, insurers, and government agencies, they have successfully reached the majority of the markets by considering the patient pool demand. While determining the cost and reimbursement, various factors, such as pharmacoeconomic analysis and outcome-based responses, as well as the added value to society, have been evaluated. The CAR T-cell-related toxicity, such as the cytokine-release syndrome and neurotoxicity, remain important potential complications of this therapy. Second generation CAR T-cell therapies are emerging with more safety and efficacy to overcome these limitations. If these limitations have been overcome, these are going to be the potential drivers of the market. After CAR-T approval companies focused on developing alternative therapies to overcome CAR-Ts limitations. LUNSUMIO became the first bispecific antibody to get approval for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more lines of systemic treatment in June 2022 in Europe. Later in December 2022, the US FDA approved it for the same indication. This was the game changing step toward a brighter future for follicular lymphoma patients. Bispecific antibodies are ready to use therapies and safer treatment options than CAR-Ts. In 2023, LUNSUMIO captured USD 55 million in revenue in the United States for follicular lymphoma. In the United States, AbbVie and Genmab's epcoritamab, marketed as EPKINLY, first gained FDA approval in May 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This was followed by its approval for follicular lymphoma in June 2024. With the recent FDA authorization for relapsed/refractory follicular lymphoma, along with expected approvals and launches in international markets, EPKINLY is poised to see revenue growth in the coming quarters. Its strong performance in treating relapsed/refractory DLBCL suggests it could achieve similar success in follicular lymphoma. LUNSUMIO now faces competition in the European market for follicular lymphoma, as on August 19, 2024, the European Commission granted approval for the expanded use of AbbVie and Genmab's bispecific antibody, TEPKINLY (epcoritamab), for treating adults with relapsed/refractory follicular lymphoma. The study showed an overall response rate of 83% and a complete response rate of 63%, with the median response duration being 21.4 months. Just after TEPKINLY approval in Europe, Regeneron's ORDSPONO (odronextamab) a CD20 x CD3 bispecific antibody approved by European Commission on August 26, 2024 for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory DLBCL, after two or more lines of systemic therapy. After this approval, ORDSPONO becomes the first off-the-shelf option that can be administered in the out-patient setting. In March 2024, the US FDA declined approval for odronextamab for treating follicular lymphoma and DLBCL. The agency issued two complete response letters concerning the biologics license application (BLA) for odronextamab in relapsed/refractory follicular lymphoma and DLBCL after two or more lines of systemic therapy. The denial was tied to the enrollment status of confirmatory trials assessing the drug. Importantly, there were no concerns raised about odronextamab's efficacy, safety, trial design, labeling, or manufacturing. Both EPKINLY, LUNSUMIO, and ORDSPONO are off-the-shelf therapies, offering greater accessibility compared to CD19 CAR-T treatments. These drugs will compete not only with each other but also with CAR-T therapies to secure a substantial portion of the follicular lymphoma market. Learn more about the FDA-approved follicular lymphoma drugs @ Drugs for Follicular Lymphoma Treatment A new class has also emerged for the treatment of follicular lymphoma, i.e., Bruton tyrosine kinase (BTK) inhibitors. In November 2023, BeiGene received approval from the European Commission for BRUKINSA (zanubrutinib) to treat relapsed/refractory follicular lymphoma. Later in March 2024, the US FDA approved BRUKINSA for the same indication. BRUKINSA is the first and only BTK inhibitor approved for this condition. To know more about follicular lymphoma treatment options, visit @ New Treatment for Follicular Lymphoma The follicular lymphoma pipeline is robust with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include AbbVie's IMBRUVICA, Xynomic Pharmaceuticals' Abexinostat, Pfizer PF-06821497, Incyte's Parsaclisib, Bristol-Myers Squibb's Nivolumab, and others. Discover which therapies are expected to grab major follicular lymphoma market share @ Follicular Lymphoma Market Report IMBRUVICA (ibrutinib) is an anti-cancer medication available in various forms, including hard gelatin capsules, tablets, film-coated tablets, and oral suspension. It is being developed by AbbVie and is currently undergoing Phase III trials for follicular lymphoma. This study aims to determine if adding ibrutinib to the treatment will extend progression-free survival (PFS) compared to using rituximab alone in patients with newly diagnosed follicular lymphoma. Xynomic Pharmaceuticals is developing Abexinostat for treating follicular lymphoma. The company is currently testing this investigational drug in a Phase II clinical trial involving patients with relapsed/refractory follicular lymphoma who have received at least three prior therapies. The US FDA has granted Abexinostat fast-track designation for this use. In June 2021, Xynomic completed a short-form merger with Xu-Nuo Pharma in a "Going Private" transaction. Post-merger, Xu-Nuo Pharma will continue Xynomic's business as its main focus. Discover more about drugs for follicular lymphoma in development @ Follicular Lymphoma Clinical Trials The anticipated launch of these emerging therapies for follicular lymphoma are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the follicular lymphoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for follicular lymphoma is expected to grow from USD 1.4 billion in 2020 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rise in the increasing incidence of follicular lymphoma. DelveInsight's latest published market report titled as Follicular Lymphoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the follicular lymphoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The follicular lymphoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Follicular Lymphoma Risk-specific Incident Cases of Follicular Lymphoma Stage-specific Incident Cases of Follicular Lymphoma Mutation-specific Incident Cases of Follicular Lymphoma Transplant Eligible and Ineligible Patient Pool of Follicular Lymphoma Refractory/Relapsed Incident Cases of Follicular Lymphoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM follicular lymphoma market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this follicular lymphoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the follicular lymphoma market. Also, stay abreast of the mitigating factors to improve your market position in the follicular lymphoma therapeutic space. Related Reports Follicular Lymphoma Pipeline Follicular Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key follicular lymphoma companies, including Incyte Corporation, Genmab A/S, BeiGene, Merck & Co., ADC Therapeutics, Xynomic Pharmaceuticals, Nordic Nanovector, TG Therapeutics Inc, Allogene Therapeutics, MEI Pharma, Innovent Biologics, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期免疫疗法上市批准快速通道临床3期

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适应症	国家/地区	公司	日期
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
大B细胞淋巴瘤	美国	Juno Therapeutics, Inc.	2024-03-18
小淋巴细胞淋巴瘤	美国	Juno Therapeutics, Inc.	2024-03-18
B细胞淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2023-05-25
B细胞淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2023-05-25
B细胞淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2023-05-25
B细胞淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2023-05-25
难治性高级别 B 细胞淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2023-05-25
难治性高级别 B 细胞淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2023-05-25
难治性高级别 B 细胞淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2023-05-25
难治性高级别 B 细胞淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2023-05-25
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

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适应症	最高研发状态	国家/地区	公司	日期
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
复发性滤泡性淋巴瘤	申请上市	美国	Bristol Myers Squibb Co.	2024-01-30
复发性滤泡性淋巴瘤	申请上市	日本	Bristol Myers Squibb Co.	2024-01-30
难治性滤泡性淋巴瘤	申请上市	美国	Bristol Myers Squibb Co.	2024-01-30
难治性滤泡性淋巴瘤	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

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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


NCT04245839 (TRANSCEND FL, Pubmed)	临床2期	滤泡性淋巴瘤二线 POD24 \| CD19	130	Lisocabtagene maraleucel (liso-cel)	築積齋蓋膚衊積鏇簾鑰(餘糧壓選齋遞廠積蓋簾) = 網鏇鏇糧積衊鬱夢憲鹹製顧鏇廠選餘鏇網窪襯 (製築鬱鑰觸齋蓋觸願繭, 91.6‒99.4) 更多	积极	2024-06-03
NCT03575351 (TRANSFORM, ASCO2024) 人工标引	临床3期	大B细胞淋巴瘤二线	184	Lisocabtagene maraleucel (liso-cel)	壓鏇憲願襯膚製襯廠壓(餘糧蓋廠夢選積顧夢醖) = 鏇鹹糧範蓋繭積簾襯糧醖壓壓膚壓鹹遞簾鹽淵 (鑰鏇淵網鏇選範憲製餘 ) 更多	积极	2024-05-24
NCT03575351 (TRANSFORM, ASCO2024) 人工标引	临床3期	大B细胞淋巴瘤二线	184	SOC	壓鏇憲願襯膚製襯廠壓(餘糧蓋廠夢選積顧夢醖) = 艱製鏇選鏇遞齋築網艱醖壓壓膚壓鹹遞簾鹽淵 (鑰鏇淵網鏇選範憲製餘 ) 更多	积极	2024-05-24
CIBMTR (ASCO2024) 人工标引	N/A	淋巴瘤	30	Lisocabtagene maraleucel (liso-cel)	壓選鬱鏇鹽鏇繭積蓋鬱(餘艱遞築範簾築膚鹹餘) = 齋積蓋獵網廠構憲淵獵選構夢鹹衊築壓製鹹顧 (鏇鏇觸蓋醖繭積製願鹹 ) 更多	积极	2024-05-24
NCT02631044 (TRANSCEND-MCL, ASCO2024) 人工标引	临床1期	套细胞淋巴瘤	88	Liso-cel	範齋餘膚膚齋築襯壓鏇(憲繭積餘膚鹽醖網選蓋) = 顧願鬱襯壓糧衊鹹範構簾遞糧鬱壓窪窪齋製選 (觸醖願遞鏇選築鏇構顧 ) 更多	积极	2024-05-24
NCT02631044 (TRANSCEND-MCL, ASCO2024) 人工标引	临床1期	套细胞淋巴瘤	88	Liso-cel (Prior LOT ≥ 2)	範齋餘膚膚齋築襯壓鏇(憲繭積餘膚鹽醖網選蓋) = 醖簾壓齋鑰構網積範範簾遞糧鬱壓窪窪齋製選 (觸醖願遞鏇選築鏇構顧 ) 更多	积极	2024-05-24
NCT04245839 (TRANSCEND FL, ASCO2024) 人工标引	临床2期	滤泡性淋巴瘤末线 \| 二线 \| 三线	124	lisocabtagene maraleucel Bridging Therapy (BT)	鹽艱鏇壓選廠觸遞壓遞(繭醖蓋蓋網艱餘簾鬱獵) = 築窪齋鹽鹽簾蓋鹽齋構鑰願膚繭餘憲願範鏇繭 (壓遞夢築憲醖醖餘廠顧 ) 更多	积极	2024-05-24
NCT04245839 (TRANSCEND FL, ASCO2024) 人工标引	临床2期	滤泡性淋巴瘤末线 \| 二线 \| 三线	124	lisocabtagene maraleucel No Bridging Therapy (NBT)	鹽艱鏇壓選廠觸遞壓遞(繭醖蓋蓋網艱餘簾鬱獵) = 範選衊鏇遞窪鹹夢範選鑰願膚繭餘憲願範鏇繭 (壓遞夢築憲醖醖餘廠顧 ) 更多	积极	2024-05-24
NCT02631044 (TRANSCEND NHL 001, Pubmed)	临床1期	套细胞淋巴瘤三线 Bruton tyrosine kinase inhibitor (BTKi) \| alkylating agent \| CD20-targeted agent ... 更多	83	Lisocabtagene maraleucel	製窪鬱製觸膚構願糧齋(鑰遞壓鏇繭築淵觸壓選) = 糧觸鏇衊衊壓網膚廠壓壓窪顧繭鹹鬱鹹鏇壓鹽 (齋觸繭蓋鏇獵簾餘簾積, 73.3 ~ 90.5) 更多	积极	2024-04-01
NCT03575351 (TRANSFORM, Pubmed) 人工标引	临床3期	非霍奇金淋巴瘤二线	184	Liso-cel	(衊網壓廠觸積齋衊蓋糧) = People who received liso-cel as a second-line treatment lived longer without the occurrence of an unfavorable medical event or worsening of the disease 膚顧鹹鏇網餘鹽艱醖艱 (繭構醖築艱範鹽觸糧醖 ) 更多	积极	2024-03-28
NCT03575351 (TRANSFORM, Pubmed) 人工标引	临床3期	非霍奇金淋巴瘤二线	184	standard of care (SOC)		积极	2024-03-28
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	大B细胞淋巴瘤	-	Nonconforming Product (NCP) of Lisocabtagene Maraleucel (liso-cel)	餘鑰糧觸襯築構壓網鑰(襯糧簾築襯遞蓋願糧糧) = 齋壓積選積鏇鹽網膚鹹廠鏇艱觸廠顧鏇衊膚積 (遞壓壓鬱構簾積窪襯糧 ) 更多	积极	2024-02-01
PILOT (Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床2期	大B细胞淋巴瘤二线	-	Lisocabtagene Maraleucel (liso-cel)	築願餘鑰鹹築蓋繭鹽選(廠餘網構鏇簾網壓壓衊) = 衊顧夢鏇窪餘製積鑰製糧淵鹹艱製蓋鬱淵築觸 (襯鑰製築繭壓製範觸獵 ) 更多	积极	2024-02-01
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	大B细胞淋巴瘤	323	Lisocabtagene Maraleucel	鹽廠選壓鹹觸膚艱簾獵(鹽醖簾鹹範選鹽醖顧糧) = 積醖鹹簾遞範淵製鹽願鏇醖壓襯糧構餘範衊憲 (糧艱遞蓋餘簾繭齋醖齋 ) 更多	积极	2024-02-01