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2025-08-15

申办/合作机构

Mayo Clinic

[+1]

NCT06855121

/ RecruitingN/AIIT

The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort

The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.

开始日期2025-01-15

申办/合作机构

St. Olavs Hospital HF

[+9]

NCT06623630

/ Recruiting临床1期IIT

A Pilot Safety and Feasibility Study of Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function

Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal function, leading to an urgent, unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population. In addition, renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations.
This study is testing the hypotheses that:
1. low-dose total body irradiation (TBI) in combination with cyclophosphamide (Cy) as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function
2. low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansion/persistence and disease response rates as those seen with standard lymphodepleting chemotherapy (fludarabine / cyclophosphamide).

开始日期2024-12-04

申办/合作机构

Washington University School of Medicine

[+2]

100 项与西达基奥仑赛相关的临床结果

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100 项与西达基奥仑赛相关的转化医学

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100 项与西达基奥仑赛相关的专利（医药）

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317

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.

2025-05-01·ANNALS OF PHARMACOTHERAPY

B-Cell Maturation Antigen-Directed Immunotherapies for the Treatment of Relapsed/Refractory Multiple Myeloma: A Review of the Literature and Implications for Clinical Practice

Review

作者: Peery, Matthew R. ; Sharps, Amanda ; Moore, Donald C. ; Hill, Hailey ; Zaver, Aarti

Objective::

To review the pharmacology, efficacy, safety, dosing and administration, and relevance to patient care and clinical practice of B-cell maturation antigen (BCMA) directed immunotherapies, including chimeric antigen receptor T-cell (CAR-T) therapy and bispecific antibodies (BsAb), for the management of relapsed/refractory multiple myeloma (RRMM).

Data Sources::

A literature review of PubMed (1966 to July 2024) was conducted using the keywords idecabtagene vicleucel , ciltacabtagene autoleucel, teclistamab, elranatamab , and multiple myeloma . Data was also obtained from unpublished meeting abstracts and prescribing information.

Study Selection and Data Extraction::

All relevant published articles, unpublished abstracts, and prescribing information on anti-BCMA immunotherapies for the treatment of RRMM were reviewed.

Data Synthesis::

Idecabtagene vicleucel and ciltacabtagene autoleucel are BCMA-directed CAR-T cell therapies that have been compared to standard of care (SOC) regimens for MM in early relapse in the phase III trials KarMMa-3 and CARTITUDE-4, respectively. Both studies demonstrated a significantly improved in response rates, depth of response, and progression-free survival compared to SOC. BsAbs teclistamab and elranatamab have been evaluated in the phase II trials MajesTEC-1 and MagnetisMM-3, respectively. Overall response rates of 63 and 61% were observed with teclistamab and elranatamab, respectively, in a population of patients with heavily pretreated RRMM.

Relevance to Patient Care and Clinical Practice in Comparison with Existing Drugs::

BCMA-directed immunotherapies have demonstrated efficacy in the treatment of RRMM. Safety issues with BCMA-directed immunotherapies include cytokine release syndrome, neurotoxicity, infections, and cytopenias. Operational challenges and issues with access to care exist with these therapies as they may be limited to institutions with the infrastructure to safely administer and monitor patients for toxicities.

Conclusion::

BCMA-directed immunotherapies represent an important advancement in the management of RRMM and have significantly added to the available treatment options for this disease.

2025-05-01·JOURNAL OF CLINICAL ONCOLOGY

Comparison of Standard-of-Care Idecabtagene Vicleucel and Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma

Article

作者: Forsberg, Peter ; Richards, Alicia ; Shune, Leyla ; Khouri, Jack ; Kocoglu, Mehmet H. ; Martin, Thomas ; Hashmi, Hamza ; Hosoya, Hitomi ; Bhurtel, Evguenia ; Midha, Shonali ; Patel, Krina K. ; Sborov, Douglas W. ; Anderson, Larry D. ; Htut, Myo ; Reshef, Ran ; Lieberman-Cribbin, Alex ; Davis, James A. ; Wagner, Charlotte ; Kaur, Gurbakhash ; Atrash, Shebli ; Raza, Shahzad ; Herr, Megan M. ; Kalariya, Nilesh ; Atanackovic, Djordje ; Oswald, Laura B. ; Locke, Frederick L. ; Janakiram, Murali ; Anwer, Faiz ; Castaneda, Omar ; Purvey, Sneha ; Afrough, Aimaz ; Peres, Lauren C. ; De Avila, Gabriel ; Asoori Maringanti, Sireesha ; Dima, Danai ; Gaballa, Mahmoud ; Mikkilineni, Lekha ; Bansal, Radhika ; McGuirk, Joseph ; Ferreri, Christopher ; Nadeem, Omar ; Lin, Yi ; Costello, Patrick ; Richard, Shambavi ; Alsina, Melissa ; Freeman, Ciara L. ; Voorhees, Peter ; Smith, Kinaya ; Dhakal, Binod ; Hansen, Doris K. ; Pasvolsky, Oren ; Sidana, Surbhi

PURPOSE:

Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), two B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapies have demonstrated remarkable efficacy in relapsed/refractory multiple myeloma (RRMM). We compare safety, efficacy, and survival among patients with RRMM treated with standard-of-care (SOC) ide-cel or cilta-cel.

METHODS:

Data were from a retrospective chart review of patients with RRMM leukapheresed by December 31, 2022, with the intent to receive SOC ide-cel or cilta-cel at 19 institutions. An inverse probability of treatment weighting (IPTW) approach was used to compare outcomes by therapy type.

RESULTS:

A total of 641 patients were leukapheresed by December 31, 2022, with ide-cel (n = 386) and cilta-cel (n = 255). Five hundred eighty-six patients were infused (n = 350 for ide-cel; n = 236 for cilta-cel) with a median follow-up of 12.6 and 13.0 months for ide-cel and cilta-cel, respectively. After IPTW, patient characteristics were well balanced. Cilta-cel was associated with higher likelihood of grade ≥3 cytokine release syndrome (CRS; odds ratio [OR], 6.80 [95% CI, 2.28 to 20.33]), infections (OR, 2.03 [95% CI, 1.41 to 2.92]), second primary malignancies (OR, 1.77 [95% CI, 0.89 to 3.56]), and delayed neurotoxicity (OR, 20.07 [95% CI, 4.46 to 90.20]). Cilta-cel was also associated with better treatment responses (≥complete response: OR, 2.42 [95% CI, 1.63 to 3.60]), longer progression-free survival (hazard ratio [HR], 0.48 [95% CI, 0.36 to 0.63]), and longer overall survival (HR, 0.67 [95% CI, 0.46 to 0.97]). No associations were observed between therapy type and immune effector cell–associated neurotoxicity syndrome, any CRS, severe cytopenia at days 30 and 90, or nonrelapse mortality. We observed consistent findings when repeating the analyses restricting the ide-cel cohort to patients infused during the same time period as Food and Drug Administration approval for cilta-cel (≥March 2022).

CONCLUSION:

Cilta-cel demonstrated superior efficacy and survival, with higher incidence of certain toxicities, compared with ide-cel.

1,403

项与西达基奥仑赛相关的新闻（医药）

2025-05-15

·氨基观察

跨越传奇不容易

氨基观察-创新药组原创出品作者 | 武月在CAR-T产品中，传奇生物的Carvykti，注定会成为最传奇的选手之一。2024年全年，收入9.63亿美元；2025年第一季度，收入3.69亿美元……Carvykti的表现过于亮眼。在创新药世界，强者总会吸引更多期待超越的后来者。毕竟，商业逻辑极为明确，而一旦数据证实，也将彻底打开预期。BCMA CAR-T就是这样一个被众多药企虎视眈眈的领域。当然，目前来看，跨越传奇也并十分不易。5月13日，Arcellx公布了其BCMA靶向CAR-T疗法anito-cel的关键性II期iMMagine-1研究最新数据。主打安全性亮点的anito-cel，被市场视为Carvykti的强劲对手。这次的数据更新，延续了此前的趋势，总缓解率（ORR）高达97%，完全缓解率（CR/sCR）达68%，且未观察到延迟性神经毒性等严重副作用。然而，市场反应却耐人寻味。数据发布后，Arcellx股价高开低走，开盘大涨13.2%后，收盘涨幅仅剩1.3%。显然，市场关于Arcellx的未来走向存在分歧。尽管anito-cel背靠吉利德，但如果最终被贴上me too标签，想象空间会大打折扣。Me too还是BIC，直接关乎anito-cel作为后来者的商业化前景与颠覆潜力。当然，BCMA CART的竞争，早已超越单纯的数据比拼，演变为商业化潜力、市场策略与医生惯性的综合角力。换句话说，挑战者必须更加强大，才有突围希望。/ 01 /最强挑战者的落寞早在2024年ASH年会上，anito-cel的初步数据已引发关注，被一些分析师视为Carvytki的有力竞争对手。这得益于其D-domain技术。简单来说，这是一种合成的方法筛选获得比scFv分子量更小的可以特异结合抗原的蛋白，能够提高靶标特异性，同时增强结合亲和力。理论上，这能为其带来疗效和安全性优势。不过，无论是此前还是如今公布的临床数据，anito-cel的疗效数据都没有明显超越Carvykti。去年12份， Arcellx公布的iMMagine-1研究数据显示，86名患者中位随访9.5个月时，ORR为97%，CR/sCR为 62%；中位PFS为30.2个月，中位随访时间为38.1个月，未达到中位总生存期。虽然跨临床对比并不准确，但根据传奇生物CARTITUDE-1研究，在27.7个月中位随访中，97名RRMM患者的ORR为98%，83%为严格完全缓解（CR），mPFS为34.9个月。显然Carvytki的样本量更大，mPFS时间更长。当然，相比疗效，anito-cel更推崇自己的安全性。众所周知，CAR-T疗法常常会带来神经毒性和CRS（细胞因子综合征）等副作用，而在1期和 iMMagine-1研究中给药的150多名患者中，均未观察到anito-cel的迟发性神经毒性，包括无帕金森综合征、无颅神经麻痹和无吉兰-巴利综合征。CRS方面也相对更好，84%接受治疗的患者出现了CRS事件，2%的患者出现了3级或更高级别的CRS事件。 Arcellx最新发布的数据，则延续了这样的趋势。疗效方面，截至5月1日，在117名患者中位数随访12.6个月时，ORR为97%，CR/sCR率为68%，6个月PFS和OS分别为91.9%和96.6%，12个月PFS和OS率分别为78.8%和95.2%，尚未达到中位PFS和中位OS。安全性方面， Arcellx表示自2024年12月上次数据展示以来，没有发生额外的治疗或疗法相关的死亡或≥3级CRS或ICANS事件。由于Arcellx此次发布的数据，是去年ASH大会上更新数据，因此，这样的数据表现，也在市场预期之中。/ 02 /Me too还是BIC华尔街对于这份“无惊喜”的成绩单反应耐人寻味。数据发布后，Arcellx股价表现平淡，开盘大涨13.2%后，收盘涨幅仅剩1.3%。尽管Arcellx CEO曾高调宣称anito-cel是同类最佳，吉利德也十分看好其潜力，但显然市场并不买账。这背后的核心或许在于，这样的anito-cel更像是me too而非BIC，打不过Carvykti。尽管Arcellx强调其安全性优势，但其曾在iMMagine-1出现3例死亡，其中还有CRS相关的1例。后续随着临床试验扩大规模和延长时间后，anito-cel是否能保持一如既往的安全，还需持续观察。疗效方面，虽然OS是首要的，但在当前很多新药的应用下，anito-cel要想证明其OS获益很困难，因此未来还是看其PFS数据。CARTITUDE-1数据显示，Carvykti的中位数PFS是34.9个月，并且CARTITUDE-1有更高的治疗线数。从这个角度出发，市场认为iMMagine-1应该在疗效上有一个相对硬性的标准。或许是为了回应市场对PFS的关注，在去年ASH的投资者交流中，Ciara L. Freeman教授介绍iMMagine-1研究时候特意提到：通过延长随访期，接受治疗患者的中位无进展生存期达到34个月。也就是说，经过努力，anito-cel或许能做到与Carvykti疗效相当。但在市场看来，若无法证明显著临床优势，anito-cel仍是追赶者。Me too还是BIC直接关乎anito-cel的商业化前景，后发性外加强生作为多发性骨髓瘤市场霸主本身的底蕴，让一切都变得不确定起来。/ 03 /永不休止的纷争Arcellx并未走到终局，未来BCMA CAR-T疗法的挑战者也仍会继续出现。因为这一领域的商业价值已经被充分证明，纷争也必然会永不休止。对于后来者来说，必须要做得足够好，才有可能撼动传奇。如果只是打平或者有限胜出，那么突围仍然不会太容易。因为，Carvykti在不断向前线推进的同时，还在努力筑起自己的护城河：强生作为多发性骨髓瘤霸主的资源加持；Carvykti的领先优势、门诊输注以及持续的额外安全管理措施。如果没有巨大的疗效、安全性优势，后来者很难颠覆。这样的故事，在血液瘤的争夺战中，我们已经看到了太多。典型如BTK抑制剂。伊布替尼于2013年获FDA批准，随着最初几年在淋巴瘤上快速拓展新适应症，销售额持续翻倍。在市场上还没有竞争对手之际，伊布替尼开发完主要适应症，牢牢卡住身位。这也导致，即使到2017年，有安全性优势的二代BTK抑制剂阿卡替尼获得FDA批准后，仍无法阻碍伊布替尼的增长。由于领先优势，2019年伊布替尼还被NCCN指南列为慢性淋巴细胞白血病和小淋巴细胞淋巴瘤一线治疗的唯一首选方案，医生用药的惯性，以及强生、艾伯维在血癌领域的积累，使得其在专利到期之前，依然是BTK之王。直到更厉害的二代BTK抑制剂，以头对头的姿态胜出，伊布替尼才日薄西山。说白了，在领跑者已经足够强势的情况下，后来者仅仅依靠“略胜一筹”的优势，要想强行超车，难度并不比研发风险小。因此，回到BCMA CAR-T的纷争来说，在当下，包括anito-cel等诸多挑战者，必须要回答一个关于未来风险/收益比能否持久提升的问题。后来者的突围之路注定不易。但或许，正是这种永不停歇的竞争，推动着细胞治疗不断突破边界，最终让更多患者受益。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

细胞疗法免疫疗法ASH会议财报临床结果

2025-05-15

·今日头条

柳叶刀-免疫治疗两年停药可行？四大细胞疗法长效猎杀肝癌/肾癌等

近年来，免疫治疗以颠覆性突破改写肿瘤治疗范式。从曾经的后线“救命稻草”，到如今的一线“抗癌主力军”，免疫检查点抑制剂、免疫细胞治疗等创新疗法显著延长患者生存期，创造了诸多生命奇迹。比如美国前总统卡特确诊晚期黑色素瘤伴脑转移后，通过免疫检查点抑制剂联合治疗，不仅清除脑部肿瘤，更实现长期生存，成为免疫治疗临床价值的典型例证。在血液肿瘤领域，CAR-T细胞疗法同样成绩斐然，宾夕法尼亚大学治疗的首位儿童患者艾米莉，经CAR-T治疗后已无癌生存超十年，为复发难治性白血病患者点燃新希望。尽管免疫治疗成果亮眼，但其最佳用药时长始终是临床争论的焦点，今年8月，《柳叶刀》子刊《The Lancet Regional Health-Europe》发表的大规模临床研究，为这一结论提供了迄今为止最权威的循证医学证据——这项覆盖数十万例患者的全球最大规模研究明确证实：患者接受免疫治疗满两年后即可在医生评估下考虑停药，继续用药难以带来额外的生存优势。下文将带您深入解析《柳叶刀》研究的具体数据，并分享临床中应用免疫细胞疗法实现停药后长期生存的经典案例，以坚定大家的抗癌信心！ ▲截图源自“THE LANCET” 一、《柳叶刀》子刊39万例患者数据重磅力证：免疫治疗满2年停药安全可行，长期生存与持续用药疗效无差异《柳叶刀》子刊发表的这项研究，共纳入了2015-2022年确诊的391,106例肺癌患者，其中43,359例因病情进展接受了帕博利珠单抗（中国首个获批上市的PD-1抑制剂，属免疫检查点抑制剂的一种）治疗。患者中67%（29,040例）为男性，确诊年龄中位数为65岁。结果显示：中位随访时间为25.9个月（范围：0-97.6个月），一线接受帕博利珠单抗治疗的中位总生存期（OS）为15.7个月（95%CI 15.3~16.0）。继续用药超过2年与固定2年疗程的总生存期无显著差异，风险比（HR）=0.97[0.75-1.26]，P=0.95 （详见下图）。 ▼帕博利珠单抗一线治疗2年后总生存率 ▲图源“Lancet Reg Health Eur”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除此外，在29个月时仍存活的患者中，继续治疗组与停止治疗组的长期生存率接近： ①4年生存率分别为 95.0%（继续治疗组，94.0-96.0） vs 96.1%（停药组，94.7-97.5）。 ②5年生存率分别为 85.6%（继续治疗组，83.7-87.6） vs 87.3%（停药组，84.4-90.3）。 ③6年生存率分别为 77.0%（继续治疗组，74.2-80.0） vs 77.2%（停药组，72.2-82.6）。显然，继续治疗超过2年未带来生存获益（HR=0.97[0.75-1.26]，P=0.95），两组总生存率几乎无差异。综上，本研究证实了晚期非小细胞肺癌患者使用帕博利珠单抗满2年后停药的安全性。但需要注意的是，由于该研究属于观察性研究，其结果可能受到混杂因素和选择偏倚的影响。 · 全球肿瘤医生网温馨提示 · 用药时长会因患者个体情况、治疗方案、营养状况、癌种及分期等因素而有所不同，具体停药时间仍需遵循医嘱。二、四大免疫细胞疗法停药后仍可长效猎杀癌细胞，横扫肝癌/淋巴瘤/肾癌/脑瘤等面对免疫药物治疗中停药风险与持续用药副作用的双重困境，医学界正探索更持久、更安全的抗癌新路径。以下四大创新疗法已在临床中崭露头角，助力肝癌、神经母细胞瘤、霍奇金淋巴瘤、肾癌等多癌种患者，在停药后实现长期无癌生存，为抗癌治疗开辟全新赛道！ CAR-T细胞疗法：助神经母细胞瘤患儿完全缓解超18年！ PART 1 CAR-T细胞疗法治疗血液肿瘤的成绩有目共睹，不仅有13款产品获批上市，更是让一位白血病患儿艾米莉创下了无癌生存12年的医学奇迹！阅读原文了解详情：无癌生存12年！首位被CAR-T治愈的患儿Emily开启新征程，晚期癌症患者也能“涅槃重生” 如今，CAR-T疗法更将治疗目标锁定在了实体瘤领域，2025年《Nature Medicine》发表了一项“应用GD2靶向CAR-T细胞疗法治疗神经母细胞瘤（NB）”的突破性I期临床研究（NCT00085930）。数据依然很震撼：在11名输注时存在活动性疾病的患者中， 1例达到部分缓解（PR），3例实现完全缓解（CR）。其中， 2例患者的完全缓解状态维持了8年；15年总生存率（OS）为36.8%，活动性疾病患者为18.2%，无病状态（NED）患者为62.5% （P=0.019，详见下图）。 ▲图源“Nature Medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除其中，最受关注的是一位神经母细胞瘤患儿（患者1144），治疗前存在骨转移病变，输注CAR-T细胞后不仅迅速达到完全缓解，更奇迹般存活超18年，且全程未接受其他抗癌治疗。而且她在缓解期内两次成功足月妊娠并分娩健康婴儿，进一步彰显了该疗法对长期生存质量的积极影响。值得一提的是，这是目前全球CAR-T疗法领域持续时间最长的实体瘤完全缓解病例，为实体瘤患者的治愈希望树立了里程碑。这一案例首次证实CAR-T疗法在实体瘤中可诱导超长期持续缓解，为突破CAR-T疗法在实体瘤领域的应用瓶颈提供了关键证据，其意义远超个案本身，为全球实体瘤患者带来了“治愈”而非“带瘤生存”的新希望。 NK-92细胞疗法创奇迹：助复发难治性霍奇金淋巴瘤患者无癌生存超10年 PART 2 杀伤细胞（自然杀伤细胞，简称NK细胞）是来源于癌症的先天免疫细胞，同时也是至关重要的先天免疫细胞，在抗肿瘤进展的先天免疫反应中发挥了作用，主要通过产生细胞因子和趋化因子来检测病毒肿瘤细胞，是公认的人体抗癌、抗感染的第一道防线！《Oncotarget》报道了一则NK-92细胞治疗霍奇金淋巴瘤（结节硬化亚型）的长期生存案例：60岁男性患者（患者03）在接受该疗法后存活超10年，且病情持续缓解。该患者此前曾接受过GDP挽救性化疗（吉西他滨+地塞米松+顺铂）、自体造血细胞移植（AHCT）、沙利度胺+长春花碱及吉西他滨单药治疗，但病情仍进展，出现腋窝和腹股沟淋巴结肿大。治疗前CT显示，双侧腋窝最大淋巴结长轴2.5cm，肠系膜及主动脉旁见1cm淋巴结（详见下图2A）。因无其他有效治疗选择，遂入组接受5个周期的NK-92治疗。结果显示：疗效呈现阶段性特征——在第一周期第23天：中期评估显示病情稳定，最大腋窝淋巴结略有缩小；在3个周期结束：影像学显示部分淋巴结缩小（图2B）；在5个周期结束：影像学显示淋巴结略有肿大（详见下图2C），但随后24个月内所有病灶均缓解（详见下图2D、2E）。治疗期间，患者因皮肤带状疱疹感染引发急性播散性脱髓鞘性脑脊髓炎，接受类固醇治疗并于6个月内缓慢减量后，神经系统功能完全康复。停止所有抗癌治疗后，患者持续保持临床和影像学缓解状态。截至研究随访（距入组试验10年），患者无症状且未检测到肿瘤活性。 ▼03号患者NK-92细胞治疗前后的连续CT扫描对比 ▲图源“Oncotarget”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除这一案例凸显了NK-92细胞疗法在难治性霍奇金淋巴瘤中的潜在长期疗效，为免疫细胞治疗在血液肿瘤中的应用提供了重要临床证据。 Vγ2Vδ2 T细胞助肾癌肺转移患者，完全缓解持续2年 PART 3 γδT细胞作为T淋巴细胞中极具特色的亚群（仅占T细胞总量的0.5%~5%），自1990年首次从肺癌患者的肿瘤浸润淋巴细胞（TIL）中分离后，其兼具先天免疫与适应性免疫特征的独特属性逐渐引发关注。这类细胞不仅在免疫应答中扮演多重角色，更以强大的抗肿瘤活性成为癌症免疫治疗的新星，目前已在晚期肺癌、肾细胞癌、恶性血液肿瘤、结直肠癌等多种实体瘤与血液肿瘤中开展临床试验，且多数研究证实其安全性与耐受性良好。其中，Vγ9Vδ2T细胞作为人类循环γδT细胞的主要亚型，既能通过识别微生物代谢物中的磷酸残基或烷基胺等非肽类小分子，又能借助T细胞受体（TCR）或刺激性NK受体，精准锁定肿瘤细胞表面过表达的特异性配体，成为抗肿瘤的核心力量。《抗癌研究》曾报道一则震撼案例：61岁男性患者确诊为右侧肾透明细胞癌（pT1b期3级），并伴肺转移，根治性肾切除术后接受干扰素α（IFN-α）治疗无效。在干扰素α（IFN-α）洗脱期后，通过白细胞分离术获取外周血单核细胞（PBMC），结合IL-2与唑来膦酸活化Vγ2Vδ2T细胞并回输。结果显示：治疗3个疗程后， CT显示多发性肺转移灶显著缩小；6个疗程后，转移灶完全消失。截至最后一次随访，患者已持续2年完全缓解（CR）状态，且未接受其他抗肿瘤治疗，其影像学变化堪称免疫治疗的典范（详见下图）。 ▼下图展示了该患者参与临床试验前、治疗第6个疗程后4个月获得的代表性CT图像 ▲图源“anticancer research”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 SCG101 TCR-T：全球首个HBV-HCC“病毒+肿瘤”双杀疗法，让肝癌患者停药后无进展生存超6.9个月 PART 4 SCG101作为全球首个在乙型肝炎病毒（HBV）相关肝细胞癌（HCC）中同时实现病毒清除与肿瘤消退的TCR-T细胞疗法，不仅能高效清除HBV-DNA整合的癌前病变细胞及HBV-HCC肿瘤细胞，特异性杀伤HBV感染的肝细胞，还能在回输后形成特异性记忆T细胞亚群，赋予疗法长期自我更新能力，持续强化抗病毒与抗肿瘤效应。 2023年法国巴黎国际细胞与基因治疗大会（ISCT）上，曾公布“SCG101 TCR-T治疗HBV相关肝细胞癌”的突破性案例：一位HBV相关肝细胞癌患者回输SCG101 TCR-T后，乙肝表面抗原阳性肝细胞实现100%清除。血清学指标显示，HBsAg水平从输注前的557.96IU/mL，在第7天骤降至1.3IU/mL，第28天近乎清零（0.08IU/mL）（详见下图）。 ▲图源“SCG”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除此外，抗癌效果同样显著：在SCG101治疗第28天，肿瘤靶病灶较基线缩小66%，达到部分缓解（PR）标准；第4个月肿瘤进一步缩小至74.5%，一处病灶完全消失。截至数据统计时，患者在未联合任何其他抗肿瘤治疗的情况下，已无进展生存超6.9个月，持续维持缓解状态，成为“TCR-T单药扭转晚期肝癌病程”的标杆性案例。 ▲图源“SCG”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除三、小编寄语虽然《柳叶刀》子刊研究证实，免疫治疗两年后停药具备安全性与合理性，为临床决策提供了重要参考。但需警惕的是，停药后的复发风险不容忽视，抗癌治疗仍需全程科学管理。由于每位患者的癌症类型、肿瘤分期、免疫状态、治疗方案及预后各不相同，免疫治疗在两年后是否停药或继续，需结合个体情况严格遵医嘱决策。此外，需要提醒广大癌友的是，癌症作为高度突变且复杂的疾病，单一疗法往往难以达到理想效果。现阶段，理想的抗癌策略需依托权威医院与专家的早期规范诊断，在传统治疗（如手术、放化疗）基础上，结合患者病情、疾病特征及经济条件，联合免疫细胞疗法（如 CAR-T、TCR-T、TIL、NK、CAR-NK 细胞疗法）、癌症疫苗、靶向药物、硼中子俘获疗法、质子治疗等创新疗法，以降低复发转移风险，尽可能延长生存期并提升生存质量。四、参考资料 [1]Rousseau A,et al.Impact of pembrolizumab treatment duration on overall survival and prognostic factors in advanced non-small cell lung cancer: a nationwide retrospective cohort study[J]. The Lancet Regional Health–Europe, 2024, 43. https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(24)00137-6/fulltext [2]Li C H,et al.Long-term outcomes of GD2-directed CAR-T cell therapy in patients with neuroblastoma[J]. Nature Medicine, 2025: 1-5. https://www.nature.com/articles/s41591-025-03513-0 [3]Williams BA,et al.A phase I trial of NK-92 cells for refractory hematological malignancies relapsing after autologous hematopoietic cell transplantation shows safety and evidence of efficacy. Oncotarget. 2017 Jul 12;8(51):89256-89268. https://pmc.ncbi.nlm.nih.gov/articles/PMC5687687/ [4]Kobayashi H,et al. Complete remission of lung metastasis following adoptive immunotherapy using activated autologous γδ T-cells in a patient with renal cell carcinoma[J]. Anticancer research, 2010, 30(2): 575-579. https://ar.iiarjournals.org/content/30/2/575.long [5]https://www.scgcell.com/newsinfo/8316197.html 本文为全球肿瘤医生网原创，未经授权严禁转载

免疫疗法细胞疗法上市批准

2025-05-13

·investors.legendbiotech.com

Legend Biotech Reports First Quarter 2025 Results and Recent Highlights

CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $369 million Over 6,000 patients treated to date Initiated CARVYKTI® clinical production at the Tech Lane facility Received positive CHMP opinion to add statistically significant improvement in overall survival from CARTITUDE-4 study to CARVYKTI® label Australia’s TGA approved CARVYKTI® in second-line plus settings for multiple myeloma patients Cash and cash equivalents, and time deposits of $1 .0 billion, as of March 31, 2025 , which Legend Biotech believes will provide financial runway into the second quarter of 2026 SOMERSET, N.J. , May 13, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) ( Legend Biotech ), a global leader in cell therapy, today reported its first quarter 2025 unaudited financial results and key corporate highlights. “CARVYKTI, underpinned by its continued strong commercial performance, continues to set the standard for CAR-T therapies in multiple myeloma,” said Ying Huang , Ph.D., Chief Executive Officer of Legend Biotech . “We believe our achievements from this past quarter, including capacity expansion and additional global approvals, are setting the stage for Legend Biotech to achieve company-wide profitability by next year. As we unlock new markets and meet growing global demand, we believe our manufacturing expansion and commercial execution will maintain CARVYKTI’s market leadership position and enable us to deliver our differentiated cell therapy to more patients around the world.” Regulatory Updates The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion for CARVYKTI® on its CARTITUDE-4 overall survival (OS) update where a statistically significant and clinically meaningful improvement was achieved. The Summary of Product Characteristics will contain progression-free survival (PFS), OS, and safety information based on second interim analysis. Australia’s Therapeutic Goods Administration (TGA) approved the registration of CARVYKTI® for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), and are refractory to lenalidomide or who have received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody. Key Business Developments Treated over 6,000 clinical and commercial patients to date. In the first quarter of 2025, initiated clinical production of CARVYKTI® at the Tech Lane facility in Ghent, Belgium . The company expects to initiate commercial production at the Tech Lane facility by the end of 2025, providing expanded capacity to meet global demand. Published Legend Biotech’s second annual Environmental, Social & Governance (ESG) report, covering fiscal year 2024 data, which aligns with the Sustainable Accounting Standards Board (SASB) Biotechnology and Pharmaceutical sector standards, the Greenhouse Gas (GHG) Protocol, and references the Global Reporting Initiative (GRI) standards; the report underscores Legend Biotech’s dedication to the long-term wellbeing and success of its company, its employees, and the patients it serves. Cash and cash equivalents, and time deposits of $1 .0 billion, which Legend Biotech believes will provide financial runway into the second quarter of 2026, when Legend Biotech anticipates potentially achieving an operating profit excluding unrealized foreign exchange gains or losses. First Quarter 2025 Financial Results Cash Position: Cash and cash equivalents, and time deposits were $1 .0 billion as of March 31, 2025 . License Revenue: License revenue was $9.3 million for the three months ended March 31, 2025 , compared to $12.2 million for the three months ended March 31, 2024 . The decrease of $2.9 million was solely attributed to revenue recognized pursuant to Legend Biotech’s license agreement with Novartis for the development, manufacture, and commercialization of LB2102 and other potential CAR-T therapies selectively targeting DLL-3 (the “Novartis License Agreement”). This revenue is recognized over time as Legend Biotech conducts a Phase 1 clinical trial for LB2102. The decrease resulted from the timing of the underlying activities performed in connection with such trial. Collaboration Revenue: Collaboration revenue was $185.6 million for the three months ended March 31, 2025 , compared to $78.5 million for the three months ended March 31, 2024 . The increase was due to an increase in revenue generated from sales of CARVYKTI® in connection with our collaboration and license agreement with Janssen (the "Janssen Agreement"). Cost of Collaboration Revenue: Cost of collaboration revenue was $69.5 million for the three months ended March 31, 2025 , compared to $49.1 million for the three months ended March 31, 2024 . The increase was primarily due to Legend Biotech’s share of the cost of sales in connection with CARVYKTI® sales under the Janssen Agreement and expenditures to support expansion in manufacturing capacity. Cost of License and Other Revenue: Cost of license and other revenue was $1.8 million for the three months ended March 31, 2025 , compared to $5.6 million for the three months ended March 31, 2024 , and consisted of costs recognized in connection with the Novartis License Agreement. Research and Development Expenses: Research and development expenses were $101.9 million for the three months ended March 31, 2025 , compared to $101.0 million for the three months ended March 31, 2024 . The increase was due to research and development activities in cilta-cel with two frontline clinical trials ongoing during 2025, offset by a decrease in other cilta-cel research and development activities. Administrative Expenses: Administrative expenses were $31.5 million for the three months ended March 31, 2025 , compared to $31.9 million for the three months ended March 31, 2024 . Administrative expenses remained relatively flat, with an increase in staffing-related expenses due to higher headcount, offset by lower IT expenses due to the timing of completion of existing projects or the initiation of new projects compared to same period in the prior year. Selling and Distribution Expenses: Selling and distribution expenses were $41.0 million for the three months ended March 31, 2025 , compared to $24 .2 million for the three months ended March 31, 2024 . The increase was due to increased costs associated with commercial activities including expansion of the sales force due to growing sales of CARVYKTI®. Net Loss: Net loss was $100.9 million for the three months ended March 31, 2025 , compared to a net loss of $59.8 million for the three months ended March 31, 2024 . Adjusted Net Loss: Adjusted net loss was $27.0 million for the three months ended March 31, 2025 , compared to an adjusted net loss of $85.3 million for the three months ended March 31, 2024 . Webcast/Conference Call Details: Legend Biotech will host its quarterly earnings call and webcast today at 8:00 am ET . To access the webcast, please visit this weblink. A replay of the webcast will be available on Legend Biotech’s website at https://investors.legendbiotech.com/events-and-presentations. About Legend Biotech With over 2,600 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities. Learn more at https://legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSStatements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to CARVYKTI®, including Legend Biotech’s expectations for CARVYKTI® and its therapeutic potential; statements related to Legend Biotech manufacturing expectations for CARVYKTI® and the ability of Legend Biotech’s manufacturing expansion and commercial execution to maintain CARVYKTI’s market leadership position; statements related to Legend Biotech’s ability to fund its operations into the second quarter of 2026 and to achieve profitability in 2026; and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on March 11, 2025 and Legend Biotech’s other filings with the SEC . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. INVESTOR CONTACT: Jessie Yeung Tel: (732) 956-8271jessie.yeung@legendbiotech.com PRESS CONTACT: Mary Ann Ondish Tel: (914) 552-4625media@legendbiotech.com *Certain prior year amounts have been reclassified to present finance income as a separate line item and to combine other income/(expense),net for comparative purposes RECONCILIATION OF IFRS TO NON-IFRS MEASURES We use Adjusted Net Loss and Adjusted Net Loss per Share (which we sometimes refer to as “Adjusted EPS” “ANL per Share”) as performance metrics. Adjusted Net Loss and ANL per share are not defined under IFRS, are not a measure of operating income, operating performance, or liquidity presented in accordance with IFRS, and are subject to important limitations. Our use of Adjusted Net Loss has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. For example: Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted Net Loss does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements. Adjusted Net Loss excludes unrealized foreign exchange gain or loss which resulted primarily from changes in the intercompany loan balances and cash balances as a result of exchange rate changes between USD and EUR. Adjusted Net Loss does not reflect changes in, or cash requirements for, our working capital needs. In addition, Adjusted Net Loss excludes such as share based compensation expense, which has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy. Also, our definition of Adjusted Net Loss and ANL per Share may not be the same as similarly titled measures used by other companies. However, we believe that providing information concerning Adjusted Net Loss and ANL per Share enhances an investor’s understanding of our financial performance. We use Adjusted Net Loss as a performance metric that guides management in its operation of and planning for the future of the business. We believe that Adjusted Net Loss provides a useful measure of our operating performance from period to period by excluding certain items that we believe are not representative of our core business. We define Adjusted Net Loss as net loss adjusted for (1) non-cash items such as depreciation and amortization, share based compensation, impairment loss, and (2) unrealized foreign exchange gain or loss mainly related to intercompany loan balances and cash deposit balances as a result of exchange rate changes between USD and EUR. ANL per Share is computed by dividing Adjusted Net Loss by the weighted average shares outstanding. A reconciliation between Adjusted Net Loss and Net Loss, the most directly comparable measure under IFRS, has been provided in the table below. Source: Legend Biotech USA Inc.

临床1期引进/卖出细胞疗法财报免疫疗法

100 项与西达基奥仑赛相关的药物交易

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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
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,

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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

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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


NCT05347485 (CTgov)	临床2期	多发性骨髓瘤	86	Ciltacabtagene Autoleucel (Cilta-cel)	獵鬱製選顧鏇鑰餘鬱鹽 = 廠築鹽艱願淵淵醖鹹蓋觸醖膚壓積齋壓築膚簾 (襯憲獵網製鏇獵製衊選, 鏇築獵衊齋蓋餘繭齋築 ~ 鑰簾鬱觸鹽齋壓淵醖獵) 更多	-	2024-12-27
NCT04181827 (CARTITUDE-4, GlobeNewswire) 人工标引	临床3期	多发性骨髓瘤	-	CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel)	遞糧遞鏇艱鏇簾選遞鹹(鑰築夢鹽顧齋簾鹹衊築) = 襯憲糧網願鹹艱膚顧鬱襯鬱壓網網範鏇築衊鏇 (壓窪衊鏇獵窪鹹齋壓壓 ) 更多	积极	2024-12-10
				Standard Therapies (pomalidomide, bortezomib, dexamethasone or daratumumab, pomalidomide, dexamethasone)	遞糧遞鏇艱鏇簾選遞鹹(鑰築夢鹽顧齋簾鹹衊築) = 鬱網願鹹鏇鏇憲積顧積襯鬱壓網網範鏇築衊鏇 (壓窪衊鏇獵窪鹹齋壓壓 ) 更多
NCT04181827 (CARTITUDE-4, ASH2024) 人工标引	临床3期	难治性多发性骨髓瘤	419	Cilta-cel	觸壓製網憲糧範製淵襯(蓋觸簾築衊襯衊壓簾網) = 網廠範選襯選構膚艱積範鏇襯夢網夢網鏇窪願 (醖繭衊繭獵獵夢鹽鹹觸, NE ~ NE) 更多	积极	2024-12-09
				Standard of Care (SoC)	觸壓製網憲糧範製淵襯(蓋觸簾築衊襯衊壓簾網) = 艱觸範襯獵鬱憲繭築網範鏇襯夢網夢網鏇窪願 (醖繭衊繭獵獵夢鹽鹹觸, 25.0 ~ NE) 更多
ASH2024	N/A	阴燃多发性骨髓瘤 \| 多发性骨髓瘤	-	Ciltacabtagene Autoleucel 0.5 x 10^6 CAR-positive T-cells/kg	壓夢遞構廠觸觸簾築蓋(蓋窪餘簾遞憲選願簾鹽) = One patient experienced grade 1 Bell’s palsy that was self-limiting and resolved within 2 weeks 願構觸網醖鬱鏇廠築膚 (醖鑰膚醖鑰襯窪壓築鹹 ) 更多	-	2024-12-09
				Ciltacabtagene Autoleucel 0.75 x 10^6 CAR-positive T-cells/kg
3791CAR-T (ASH2024) 人工标引	N/A	多发性骨髓瘤	-	Ide-cel	遞獵壓製鬱遞觸襯憲簾(窪淵蓋簾鹽衊範遞繭顧) = 艱齋繭醖製膚觸獵廠壓簾構膚壓夢觸淵網鹹鏇 (鹹選窪顧鬱構顧憲夢鬱 ) 更多	相似	2024-12-08
				Cilta-cel	遞獵壓製鬱遞觸襯憲簾(窪淵蓋簾鹽衊範遞繭顧) = 遞繭蓋顧襯鑰築積齋齋簾構膚壓夢觸淵網鹹鏇 (鹹選窪顧鬱構顧憲夢鬱 ) 更多
ASH2024	N/A	难治性多发性骨髓瘤	-	Ciltacabtagene Autoleucel (cilta-cel)	遞廠艱蓋艱獵鑰鑰選選(餘選夢襯夢製構簾獵鏇): RR = 1.2 (95% CI, 1.06 ~ 1.36), P-Value = 0.0167 更多	-	2024-12-08
				Idecabtagene Vicleucel (ide-cel)
NCT04181827 (CARTITUDE-4, ASH2024) 人工标引	临床3期	多发性骨髓瘤	-	Ciltacabtagene autoleucel (cilta-cel)	廠繭艱憲鬱繭網構鏇鬱(積築鹹網齋觸築選鹹鹹) = 網憲製鹽壓鹽積鬱鹽廠網範壓鏇網顧顧構壓夢 (膚網願膚鹽鏇構製蓋鹹, 39.92 ~ NR) 更多	积极	2024-12-07
				Standard of Care (SOC)	廠繭艱憲鬱繭網構鏇鬱(積築鹹網齋觸築選鹹鹹) = 觸遞鏇選顧蓋簾積艱廠網範壓鏇網顧顧構壓夢 (膚網願膚鹽鏇構製蓋鹹, 32.03 ~ NR) 更多
NCT04181827 (CARTITUDE-4, GlobeNewswire) 人工标引	临床3期	多发性骨髓瘤二线	419	CARVYKTI®	窪齋網築製獵窪選窪夢(鬱鹹獵窪憲繭選衊憲獵) = 襯鑰願夢獵廠淵糧繭壓鏇壓繭觸觸網鑰糧憲鹽 (鬱壓選獵鹽夢膚選鬱餘, NE ~ NE) 更多	积极	2024-09-27
				Pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)	窪齋網築製獵窪選窪夢(鬱鹹獵窪憲繭選衊憲獵) = 繭遞餘選觸廠網齋積醖鏇壓繭觸觸網鑰糧憲鹽 (鬱壓選獵鹽夢膚選鬱餘, NE) 更多
NCT04181827 (CARTITUDE-4, SOHO2024)	临床3期	多发性骨髓瘤二线 lenalidomide-refractory \| FHR MM	136	Ciltacabtagene autoleucel	鏇餘壓窪夢艱積積膚糧(鏇構範願憲觸窪糧選構) = 鏇夢壓願鹹壓遞憲廠鹽壓窪糧獵醖積鹹醖觸壓 (範壓觸鹹鹹壓壓艱構鏇 ) 更多	积极	2024-09-04
				Ciltacabtagene Autoleucel (Standard of Care)	鏇餘壓窪夢艱積積膚糧(鏇構範願憲觸窪糧選構) = 憲窪鹹觸願淵觸衊壓膚壓窪糧獵醖積鹹醖觸壓 (範壓觸鹹鹹壓壓艱構鏇 ) 更多
NCT04181827 (CARTITUDE-4, SOHO2024)	临床3期	多发性骨髓瘤 del(17p) \| t(4;14) \| t(14;16) ... 更多	394	Ciltacabtagene autoleucel	顧廠夢鬱淵構醖築鬱鏇(繭繭積齋繭獵鑰襯鏇選) = 夢獵構觸鹹範獵廠憲積積夢鹽窪獵壓醖淵淵膚 (襯獵襯獵觸廠觸鬱鏇築 ) 更多	积极	2024-09-04
				Standard of Care (SOC)	顧廠夢鬱淵構醖築鬱鏇(繭繭積齋繭獵鑰襯鏇選) = 鏇糧顧顧顧範齋壓膚積積夢鹽窪獵壓醖淵淵膚 (襯獵襯獵觸廠觸鬱鏇築 ) 更多