欧贝妥基奥仑赛(Obecabatagene autoleucel) - 药物靶点：CD19_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，难治性 B 细胞急性淋巴细胞白血病_专利_临床

概要

基本信息

药物类型

自体CAR-T

别名

Anti-CD19 CAR T cell therapy (Autolus Therapeutics)、CD19 CAR T-cells、CD19CAT-41BBZ CAR T-cells

+ [7]

靶点

CD19

作用方式

调节剂、刺激剂

作用机制

CD19调节剂(B淋巴细胞抗原CD19调节剂)、免疫刺激剂、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+ [3]

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难治性 B 细胞急性淋巴细胞白血病+ [10]

非在研适应症

复发性弥漫性大B细胞淋巴瘤

原研机构

University College London

在研机构

Autolus Ltd.

University College London

Autolus Therapeutics Plc

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2024-11-08),

前体B细胞急性淋巴细胞白血病

最高研发阶段(中国)-

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先药物（PRIME） (欧盟)、再生医学先进疗法 (美国)

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结构/序列

Sequence Code 1277314386

来源: *****

关联

6

项与欧贝妥基奥仑赛相关的临床试验

NCT06333483

/ Recruiting临床1期

A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients With Severe, Refractory Systemic Lupus Erythematosus

This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.

开始日期2024-02-02

申办/合作机构

Autolus Ltd.

NCT06173518

/ Recruiting临床1期

A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients With CD19-Positive Relapsed/ Refractory (r/r) B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL)

This is a Phase Ib study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL)

开始日期2023-11-16

申办/合作机构

Autolus Ltd.

ACTRN12621000762853

/ Recruiting临床1期IIT

Phase I Clinical Trial of MB.CART19.1 CD19 Chimeric Antigen Receptor (CAR)T Cells in Relapsed or Refractory CD19-Positive Haematological Malignancy

开始日期2021-07-21

申办/合作机构

Metro North Hospital & Health Service

100 项与欧贝妥基奥仑赛相关的临床结果

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100 项与欧贝妥基奥仑赛相关的转化医学

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100 项与欧贝妥基奥仑赛相关的专利（医药）

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36

项与欧贝妥基奥仑赛相关的文献（医药）

2025-04-22·Blood Advances

Phase 1 study of CD19 CAR T-cell therapy harboring a fully human scFv in CAR-naïve adult patients with B-ALL

Article

作者: Kimble, Erik L. ; Fiorenza, Salvatore ; Riddell, Stanley R. ; Braathen, Kristina ; Wu, Qian (Vicky) ; Cassaday, Ryan D. ; Maloney, David G. ; Huang, Jennifer J. ; Kopmar, Noam E. ; Basom, Ryan ; Gauthier, Jordan ; Turtle, Cameron J. ; Jaeger-Ruckstuhl, Carla A. ; Liang, Emily C. ; Voutsinas, Jenna M. ; Kirchmeier, Delaney R. ; Torkelson, Aiko ; Pender, Barbara S. ; Shadman, Mazyar ; Hirayama, Alexandre V.

Abstract:

CD19-directed chimeric antigen receptor–engineered (CAR) T-cell therapy elicits high response rates but fails to induce durable responses in most adults with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). In a previous clinical trial, we observed anti-CAR immune responses associated with impaired in vivo CAR T-cell expansion after second infusions. Because these CD8+ T-cell responses were predominantly directed at peptides derived from the murine single-chain variable fragment (scFv) in the CAR, we conducted a clinical trial investigating the safety and efficacy of CD19 CAR T-cells engineered with a CAR incorporating a fully human scFv (JCAR021) in adults with R/R B-ALL (NCT03103971). Twenty-three patients received lymphodepletion chemotherapy and JCAR021 infusion. Nineteen patients developed cytokine release syndrome (any grade, 83%; grade 2, 61%) and 12 developed neurotoxicity (52%; grade ≥3, 35%). The overall response and complete response (CR)/CR with incomplete hematologic recovery (CRi) rates were 82% and 64%, respectively. We observed measurable residual disease–negative bone marrow (BM) responses in 82% of those with BM disease and extramedullary responses by positron emission tomography–computed tomography in 79% (CR, 50%) of those with measurable fluorodeoxyglucose-avid disease. The median duration of remission (DOR) was 10 months with a 4-year DOR probability of 29%. Four patients underwent allogeneic hematopoietic cell transplantation while in CR/CRi after JCAR021. Durable remissions were observed in patients with low BM disease burden. In contrast, the DOR was limited in those with high BM burden. We observed similar outcomes in CAR-naïve adult patients with B-ALL receiving CD19 CAR T cells expressing a fully human or murine scFv-containing CAR. This trial was registered at www.ClinicalTrials.gov as #NCT03103971.

2025-04-15·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Obecabtagene Autoleucel for B-Cell Acute Lymphoblastic Leukemia

Article

作者: Przepiorka, Donna ; Fashoyin-Aje, Lola A. ; Bouchkouj, Najat

This JAMA Insights discusses the recent FDA approval of obecabtagene autoleucel for adults with relapsed or refractory B-cell acute lymphoblastic leukemia and provides regulatory considerations.

2025-04-08·Blood Advances

Pretreatment pulmonary function testing has limited utility in B-cell lymphoma treated with CD19 CAR T cells

Article

作者: Sdayoor, Inbal ; Marcus, Ronit ; Jacoby, Elad ; Itzhaki, Orit ; Nagler, Arnon ; Segel, Michael J. ; Fried, Shalev ; Kedmi, Meirav ; Danylesko, Ivetta ; Shimoni, Avichai ; Yerushalmi, Ronit ; Avigdor, Abraham ; Shouval, Roni ; Shem-Tov, Noga

Abstract:

Pulmonary function tests (PFTs) are recommended for hematopoietic cell transplantation (HCT) evaluation. However, their prognostic value in chimeric antigen receptor T-cell (CAR-T) therapy remains unclear. We assessed the predictive significance of PFTs and pulmonary comorbidity classifications, per the Hematopoietic Cell Transplantation–Comorbidity Index (HCT-CI), in patients with B-cell lymphoma undergoing autologous CD19 CAR-T therapy. Single-center retrospective analysis encompassing 192 patients with relapsed/refractory B-cell lymphoma (BCL), treated with commercial and point-of-care CD19-directed CAR-T therapy. Pretherapy PFTs were conducted, and patients were stratified into 3 HCT-CI–based pulmonary comorbidity grades, using forced expiratory volume in 1 second (FEV1) and single-breath diffusing capacity for carbon monoxide (DLCO). Outcomes and toxicities were evaluated using univariate and multivariable Cox regression, logistic regression, Kaplan-Meier method, and spline models. Pulmonary comorbidity measures were not correlated with overall response rates or immune toxicities, including cytokine release syndrome grade >2 and immune effector cell–associated neurotoxicity grade >2. Categorical FEV1, DLCO, and pulmonary comorbidity level did not correlate with overall survival (OS; P = .3, P = .4, P = .6, respectively) or progression-free survival (PFS; P = .058, P > .9, P = .2, respectively). FEV1 as a continuous measure was associated with reduced PFS in a multivariable model (hazard ratio, 0.87; 95% confidence interval, 0.78-0.96; P = .007). Spline modeling demonstrated a linear correlation between FEV1 and PFS. Categorical FEV1, DLCO, and pulmonary comorbidity level failed to predict therapy efficacy or toxicity. FEV1 as a continuous measure was the sole PFT measure associated with PFS, independent of OS or severe toxicities.

103

项与欧贝妥基奥仑赛相关的新闻（医药）

2025-04-29

·蒲公英Ouryao

一周 | 国际法规药事(04.21-04.27)

◆ ◆ ◆ ◆Paul's Insight2025年4月21日-4月27日◆ ◆ ◆ ◆过去一周（4月21日至4月27日），全球药事监管和行业机构齐齐发声，犹如一场精彩的药品政策与科技盛宴。从FDA的合成色素退市行动，到EMA的罕见病新疗法推荐；从EDQM对生物制品检测标准的升级，到MHRA多款创新疗法的批准；再到行业协会PDA和ISPE在指南与实践层面的多重发力，这一连串新闻不仅彰显了各大机构的监管力度，更映射出制药行业在创新、合规与可持续性间的不断平衡。美国FDA从食药安全到创新药物的“双轨”发力1. 合成食用色素“退场”行动4月22日，美国FDA宣布，计划逐步淘汰美国食品供应中的合成色素（Petroleum-Based Synthetic Dyes），为儿童健康撑起防护伞。FDA表示，这一举措，是“让美国再次健康”（Make America Healthy Again）计划的重要里程碑。此前，1月15日赤藓红（FD&C Red No. 3）禁用已拉开了帷幕，后续这一更广泛的色素退市，将持续推动产业寻求天然、低风险的替代方案。图：赤藓红禁用后，FDA再推新规，八大合成食用色素将退场https://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply2. 药品安全敲响警钟：外用非那雄胺安全红线4月22日，FDA对市场上未经批准的外用非那雄胺配药制剂发出警示，提醒医疗机构、药房及消费者：目前无任何局部非那雄胺产品拥有FDA批准的标签和安全、有效性验证，配制药剂可能隐藏严重风险，包括与米诺地尔等混合制剂的混用场景。FDA直指部分处方药店和远程医疗平台的药品安全风险行为，呼吁行业加强自律与审查。图：就非那雄胺外用安全问题，FDA发布脱发常用药警示https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded3. 中国创新药的海外“登台”——派安普利单抗获批4月24日，FDA官网放出重磅消息：康方生物自主研发的PD1单抗派安普利单抗（Penpulimabkcqx）获批，用于复发或转移性非角化型鼻咽癌（NPC）治疗。该产品采用IgG1亚型Fc段改造设计，依托突破性疗法认定、孤儿药资格和快速通道三重加速，联袂正大天晴药业集团布局后续商业化。此举不仅为全球鼻咽癌患者带来曙光，也标志着中国创新药在国际舞台上稳步迈进。（点击此处查看相关阅读）图：中国制药行业又一里程碑，派安普利单抗获FDA批准进入美国市场https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma美国PDA发布新闻季刊4月24日，美国注射剂协会（PDA）发布新闻季刊，总结其在过去一个季度的工作，要点如下。图：PDA发布新闻季刊https://www.pda.org/pda-letter-portal/home/full-article/community-news-quarterly-april-20251）2024年PDA出版奖揭晓PDA颁发奖项给Novartis&Ogilvy团队，表彰其用于无菌性检测的创新方法，该论文名为《一种利用固相流式细胞术进行细胞制备、培养基和缓冲液的快速无菌方法》。年度PDA Letter文章奖项授予武田制药的《理解日本品质》。2）区域分会动态：德国、奥地利和瑞士分会（DACH）亮点纷呈DACH分会“目视检测与颗粒挑战”网络研讨会吸引400余名专家，聚焦AI时代的风险基础方法与质量设计。PDA表示，此次网络研讨会超出预期，如此高的参与度凸显了业界对目视检测和颗粒物相关挑战的关注，同时也强化了DACH分会促进制药行业知识交流和最佳实践的使命。欧盟EMA欧盟罕见病与适应症扩展双管齐下1. DMD新疗法——组蛋白去乙酰化酶（HDAC）抑制剂获“有条件上市许可”4月25日，欧洲药品管理局（EMA）发布杜氏肌营养不良症（DMD）创新药物Duvyzat（givinostat）“有条件上市许可”建议。该组蛋白去乙酰化酶（HDAC）抑制剂在120例6岁以上患者的18个月研究中显著延缓台阶攀爬时间，虽次要终点未全部显著，但整体数据朝积极方向发展。获得“有条件上市许可”，这是欧盟的监管机制之一，旨在促进早期上市药物，以满足未满足医疗需求的。EMA要求申请人后续进行一项随机、安慰剂对照研究，并进行长期随访将补足盲点。上市许可人为Italfarmaco S.p.A.，是是一家总部位于意大利米兰的制药跨国公司。图：杜氏肌营养不良症（DMD）创新药物获“有条件上市许可”https://www.ema.europa.eu/en/news/new-treatment-against-duchenne-muscular-dystrophy2. 甲状腺眼病首创疗法Tepezza获积极审评意见4月25日，EMA对甲状腺眼病（TED）首款靶向IGF1受体的单抗Teprotumumab（Tepezza）给出积极评审意见。三项RCT临床显示活动期患者24周内眼球突出度平均减少2.0–2.3mm，临床活动评分大幅改善；慢性期亦有约1.5mm降低。基于肌肉痉挛、脱发等可管理风险，EMA将附加风险最小化措施并转交欧委会审批。申请人为Amgen Europe B.V.，是全球领先的生物技术公司安进在欧洲的子公司。图：甲状腺眼病首创疗法Tepezza获积极审评意见https://www.ema.europa.eu/en/news/first-treatment-against-severe-thyroid-eye-disease3. CHMP会议要点：新药、扩展、再审与撤回4月22–25日的EMA人药委员会（CHMP）会议，推荐16款新药（包含Vertex囊性纤维化三联疗法、差异化适应症的多款孤用药及九款生物类似药），推动10项适应症扩展，如武田制药的Adcetris多淋巴瘤适应等；同时，礼来的阿尔茨海默药物Kisunla申请再审，Biohaven和辉瑞的两款产品适应失利撤回。整体来看，EMA通过CMA平衡未满足需求与证据要求，也显示出对成熟产品生命周期管理策略的开放态度。图：2025年4月22日至25日人药委员会( CHMP )会议要点https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2025欧洲EDQM高通量测序入典，提升生物制品安全4月23日，EDQM欧洲药典委员会（EPC）正式采纳通则“2.6.41病毒外源性因子检测的高通量测序（HTS）”，自2026年4月1日起生效。新章节涵盖非靶向与靶向HTS方法学、基因组/转录组数据分析和验证指南，驱动与ICH Q5A(R2)修订及WHO国际参考组协同，助力生物制品从传统动物实验迈向更高灵敏度的分子检测。图：高通量测序入欧洲药典https://www.edqm.eu/en/-/epc-adopts-cutting-edge-hts-chapter-to-enhance-viral-contaminant-detection-in-biological-products英国MHRA创新疗法齐发1. 4月拜耳新药Acoramidis获批，用于心肌病4月25日，MHRA批准拜耳制药的Acoramidis（Beyonttra），用于治疗因变异型或野生型转甲状腺素蛋白淀粉样变性（ATTR-CM）引起的心肌病（心肌损伤）成年患者。，632例国际多中心研究显示30个月心血管住院率和死亡率显著降低，6分钟步行距离改善。口服每日两次，通过IRP机制加速审评。图：拜耳新药Acoramidis获批，用于心肌病https://www.gov.uk/government/news/acoramidis-approved-to-treat-wild-type-or-variant-transthyretin-amyloidosis-in-adults-with-cardiomyopathy2. 白血病CAR-T疗法Obecabtagene autoleucel获有条件上市批准4月25日，obecabtagene autoleucel (Aucatzyl) 这一CART疗法获条件上市许可，用于治疗复发或难治性B 细胞前体急性淋巴细胞白血病 (ALL) 的成年患者。FELIX研究153例数据显示12个月总生存率81%、完全缓解55%，后续需提供更多数据满足全面上市要求。上市许可人为Autolus Therapeutics，是一家总部位于英国的生物制药公司，该公司于2014 年从伦敦大学学院（UCL）分拆成立。图：白血病CAR T疗法Obecabtagene autoleucel获有条件上市批准https://www.gov.uk/government/news/obecabtagene-autoleucel-conditionally-approved-to-treat-adults-with-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic-leukaemia3. 百健新药在英获批4月23日，MHRA批准了 omaveloxolone（Skyclarys），这是英国首个针对 16 岁及以上患者的治疗药物，用于治疗一种名为弗里德赖希共济失调的罕见神经退行性运动障碍。弗里德赖希共济失调是最常见的遗传性共济失调（由遗传基因引起）。据估计，每5万人中至少有1人患有此病。弗里德赖希共济失调的症状包括平衡和运动障碍，并会随着时间的推移逐渐恶化。该药物为口服胶囊剂。上市许可人为Biogen Netherlands B.V.，为全球领先的生物技术公司 Biogen Inc.（百健公司）在荷兰的全资子公司。图：百健新药在英获批https://www.gov.uk/government/news/mhra-approves-first-uk-treatment-for-friedreichs-ataxia-omaveloxolone4. 辉瑞血友病药物获批4月22日，MHRA批准辉瑞药物Marstacimab（Hympavzi），用于预防或减少12岁及以上、体重至少35公斤的血友病A和B患者的出血。该药物是同类药物中第一个通过针对血液凝固过程中的蛋白质来发挥作用的药物。Marstacimab每周一次皮下注射，使用预充式注射器或注射笔。患者或护理人员经过适当培训后即可自行注射药物。图：辉瑞血友病药物获批https://www.gov.uk/government/news/marstacimab-approved-to-treat-patients-aged-12-years-and-above-weighing-at-least-35-kg-with-haemophilia-a-or-b国际ISPE发布数字化验证良好实践指南国际制药工程协会（ISPE）发布了《数字化验证良好实践指南》（Good Practice Guide: Digital Validation），为制药企业提供从传统验证向数字化框架过渡提供了指导。这本90页的指导文件，旨在帮助制药企业采用数字化验证工具（Digital Validation Tools, DVT），提升数据可靠性、运营效率和监管合规性。该指南由全球专家团队开发，其核心成员来自于武田制药、葛兰素史克等全球药企和行业咨询公司。ISPE表示，指南结合真实案例和结构化方法，适用于从初创到优化现有系统的各类企业。（点击此处查看相关阅读）图：ISPE最新发布《数字化验证良好实践指南》https://ispe.org/publications/guidance-documents/good-practice-guide-digital-validation结语回望过去一周，FDA、EMA、EDQM、MHRA、PDA和ISPE等监管与行业机构的多项决策、指南与更新，彰显监管严谨，又鼓励技术革新。从食品安全到精准疗法，从分子检测到数字化治理，昭示出全球制药行业正朝着更健康、更高效、更可持续的未来协奏。END声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。活动推荐5月6日 | 线上 | 新法规和应用场景下的全球包材注册策略和最佳实践5月8日 | 线上 | 双维度解锁无菌药品生产污染防控策略

孤儿药突破性疗法上市批准医药出海申请上市

2025-04-29

·PMLiVE

MHRA approves Autolus Therapeutics’ Aucatzyl to treat acute lymphoblastic leukaemia

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel) to treat acute lymphoblastic leukaemia (ALL). The CAR T-cell therapy has been specifically authorised for use in adults with relapsed or refractory (R/R) B-cell precursor ALL. Approximately 765 new cases of ALL, an aggressive blood cancer, are diagnosed in the UK every year. Up to 50% of patients will relapse following frontline treatment, and survival rates remain very poor in adults with R/R disease. Administered as an intravenous infusion, Aucatzyl works by taking patients’ T cells and transforming them into CD19-targeting CAR T cells. When transferred back into the body, these modified cells can recognise and destroy the cancer cells. The MHRA’s decision on the therapy was supported by data from the open-label FELIX trial, in which 52 of the 94 R/R B-cell ALL patients who were given at least one infusion of Aucatzyl showed complete remission of the disease with an 81% probability of overall survival at 12 months. Julian Beach, MHRA interim executive director, healthcare quality and access, said: “We are committed to making innovative treatment options, like CAR T-cell therapy, available to patients as quickly as possible, ensuring our approval is underpinned by robust evidence of efficacy alongside the highest standards of safety. “We are assured that the appropriate regulatory standards for the approval of this medicine have been met.” In line with its conditional marketing authorisation pathway, the MHRA will review new efficacy and safety information for Aucatzyl at least once every year. The therapy is now being evaluated by the National Institute for Health and Care Excellence (NICE) for potential use on the NHS. FELIX lead investigator, Claire Roddie, University College London Cancer Institute, said: “Having treated a number of patients with Aucatzyl as part of the FELIX clinical trial, I am delighted that we have moved closer to eligible R/R B-cell ALL patients being able to access Aucatzyl. “We now look forward to NICE completing its assessment of the medicine to potentially make it an option for eligible patients on the NHS.”

细胞疗法免疫疗法临床结果临床研究上市批准

2025-03-21

·Endpoints

Akeso shares new data for bispecific in cervical cancer; Pulmatrix to divest assets

+Plus, news about Autolus, MacroGenics and BlissBio: Akeso bispecific looks promising in cervical cancer: The China-based biotech said Friday that all patients in a Phase 3 cervical cancer trial responded to treatment with a bispecific antibody called cadonilimab. The addition of the PD-1xCTLA-4 bispecific on top of chemoradiotherapy in the COMPASSION-18 study generated complete and partial response rates of 84.8% and 15.2%, respectively. Median PFS was not reached, but the 12-month PFS rate was 74.9%. Cadonilimab is already approved in China for patients with recurrent or metastatic cervical cancer who have not responded to platinum-based chemotherapy. — Elizabeth Cairns Pulmatrix to divest assets ahead of merger: The biotech will seek buyers for three of its pipeline programs as well as its iSPERSE platform technology. Pulmatrix in November agreed to a reverse merger with Cullgen, which was expected to close this month but is now set to close in the first half of 2025. — Max Gelman BioNTech’s option for Autolus CAR-T fizzles out: The German biotech allowed its option to lapse for AUTO1/22, a CAR-T cell therapy in Phase 1 trials for childhood acute lymphoblastic leukemia. Back in February 2024 , BioNTech paid $50 million in cash and bought $200 million of Autolus’ shares in a deal that granted it access to AUTO1/22. The deal also covered AUTO6NG, a programmed T-cell therapy in early trials in neuroblastoma, and Aucatzyl, which has since been approved for an aggressive form of leukemia. BioNTech declined to exercise its time-limited option to AUTO1/22 because of a pipeline prioritization , and it lapsed Feb. 8. — Elizabeth Cairns MacroGenics shelves prostate cancer ADC: The company had to stop dosing prostate cancer patients in a Phase 2 trial of its antibody-drug conjugate, called vobramitamab duocarmazine, in July . On Thursday , it said it would shut down all development and seek a partner for the product, which targets the tumor antigen B7-H3 and delivers a cytotoxic duocarmycin payload. MacroGenics said the results of the trial do not justify any more investment; in the patients treated before dosing was halted, mature median radiographic progression-free survival was 9.5 months with the lower dose and 10 months with the higher. — Elizabeth Cairns BlissBio to proceed with ADC on its own: Eisai had signed an option deal in 2023 to advance a BlissBio program called BB-1701, but last month said in its third-quarter earnings that it would no longer do so. Instead, BlissBio will develop BB-1701 on its own. Eisai had been partnered with liquid biopsy company Angle on development plans, and now Angle is planning to work with BlissBio. — Max Gelman

临床结果免疫疗法细胞疗法临床2期上市批准

100 项与欧贝妥基奥仑赛相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
前体B细胞急性淋巴细胞白血病	美国	Autolus Ltd.	2024-11-08

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 B 细胞急性淋巴细胞白血病	申请上市	美国	Autolus Therapeutics Plc	2023-11-29
难治性 B 细胞急性淋巴细胞白血病	申请上市	美国	Autolus Therapeutics Plc	2023-11-29
系统性红斑狼疮	临床1期	西班牙	Autolus Ltd.	2024-02-02
系统性红斑狼疮	临床1期	英国	Autolus Ltd.	2024-02-02
侵袭性 B 细胞非霍奇金淋巴瘤	临床1期	美国	Autolus Ltd.	2023-11-16
侵袭性 B 细胞非霍奇金淋巴瘤	临床1期	西班牙	Autolus Ltd.	2023-11-16
侵袭性 B 细胞非霍奇金淋巴瘤	临床1期	英国	Autolus Ltd.	2023-11-16
伯基特淋巴瘤	临床1期	美国	Autolus Ltd.	2023-11-16
伯基特淋巴瘤	临床1期	西班牙	Autolus Ltd.	2023-11-16
伯基特淋巴瘤	临床1期	英国	Autolus Ltd.	2023-11-16

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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


NCT04404660 (FELIX, ASH2024)	临床1/2期	复发性成人急性淋巴细胞白血病 ClonoSEQ®next-generation sequencing (NGS) assay	127	Obe-cel	範餘醖糧淵壓鹽襯糧壓(蓋鬱廠製蓋選壓觸淵繭) = 齋遞願壓膚鏇鑰憲築夢選鏇顧齋艱醖構積醖醖 (衊鏇鏇廠衊廠艱餘鹹鏇 ) 更多	积极	2024-12-09
NCT04404660 (FELIX, ASH2024)	临床1/2期	复发性成人急性淋巴细胞白血病 CD19	127	Obecabtagene autoleucel (obe-cel)	憲膚選夢築構壓簾淵築(餘遞範壓鹽壓廠製醖築) = 72 (70.6%) were CRS only 觸構鬱遞鹽憲願範廠構 (範廠糧糧鹽築餘襯積餘 ) 更多	积极	2024-12-09
ASH2024	N/A	复发性 B 细胞急性淋巴细胞白血病	-	Obecabtagene autoleucel (obe-cel) (High-risk HT score)	獵廠艱網觸選觸範鬱積(艱餘餘廠鬱顧夢積築網) = 鬱觸夢餘壓鹽獵淵鬱餘鏇繭積膚淵範積築憲窪 (鹹鬱遞遞醖範憲憲膚鑰, 34.6 ~ 55.6) 更多	-	2024-12-09
				Obecabtagene autoleucel (obe-cel) (Low-risk HT score)	獵廠艱網觸選觸範鬱積(艱餘餘廠鬱顧夢積築網) = 衊鹽襯壓糧壓顧淵繭夢鏇繭積膚淵範積築憲窪 (鹹鬱遞遞醖範憲憲膚鑰, 40.2 ~ 82.1) 更多
ASH2024	N/A	复发性成人急性淋巴细胞白血病	-	Bridging Therapies with Inotuzumab Ozogamicin (INO)	觸淵獵艱網選鹹築膚獵(醖鏇遞醖醖糧築觸願遞) = 壓願糧範衊鏇製糧鹹鹹壓築艱範簾顧範艱構範 (夢遞鹽齋選獵鑰網簾窪, 4.1 ~ NE) 更多	-	2024-12-08
				Bridging Therapies without Inotuzumab Ozogamicin (INO)	觸淵獵艱網選鹹築膚獵(醖鏇遞醖醖糧築觸願遞) = 範遞鑰築齋憲構鹽願願壓築艱範簾顧範艱構範 (夢遞鹽齋選獵鑰網簾窪, 6.0 ~ 15.0) 更多
NCT04404660 (FELIX, FDA_CBER) 人工标引	临床1/2期	前体B细胞急性淋巴细胞白血病	112	AUCATZYL (Efficacy Evaluable)	衊糧鑰築築願網獵觸觸(衊醖願網範鹽構選醖廠) = 鹹淵鏇鹽蓋襯製齋醖觸夢築願鹽廠製積艱網夢 (積壓網範範夢鑰鏇觸遞, 50 ~ 75) 更多	积极	2024-11-08
				AUCATZYL (All Leukapheresed)	衊糧鑰築築願網獵觸觸(衊醖願網範鹽構選醖廠) = 夢淵構選壓範蓋顧觸製夢築願鹽廠製積艱網夢 (積壓網範範夢鑰鏇觸遞, 44 ~ 63) 更多
NCT04404660 (FELIX, SOHO2024)	临床1/2期	复发性成人急性淋巴细胞白血病	127	Obecabtagene Autoleucel (Obe-Cel) (Low TB)	網窪繭鑰觸壓夢觸糧製(鹹蓋餘艱齋夢簾遞蓋積) = 夢膚壓齋選膚艱觸鑰憲鹹齋觸鹹糧願艱膚鑰艱 (網齋廠廠網繭願憲構鏇, 1.527–2.802) 更多	积极	2024-09-04
				Obecabtagene Autoleucel (Obe-Cel) (High TB)	衊餘衊築糧願衊襯觸壓(衊繭廠築願積鹽鹹積構) = 積鏇範鑰憲蓋夢醖鏇獵遞蓋衊餘齋憲壓簾鹹觸 (鑰願艱壓糧廠鑰窪鑰獵 ) 更多
NCT04404660 (FELIX, ASCO2024) 人工标引	临床1/2期	复发性 B 细胞急性淋巴细胞白血病 \| 难治性 B 细胞急性淋巴细胞白血病 CD19 binder	127	Obe-cel	觸構顧簾築鬱鹹憲獵衊(鹽夢衊鏇艱淵艱廠鹽獵) = Pts who experienced B-cell recovery had a hazard risk of relapse or death 1.7 times compared with pts without B-cell recovery 廠選憲衊鏇築廠願艱壓 (獵醖蓋醖鬱窪顧獵鬱構 ) 更多	积极	2024-05-24
				Obe-cel (with censoring for consolidative SCT or new therapies)
NCT04404660 (FELIX, EHA2024) 人工标引	临床1/2期	前体B细胞急性淋巴细胞白血病	127	Obecabtagene autoleucel (obe-cel)	範網鑰築鏇鹽鹹夢艱鑰(醖製遞願夢襯鑰餘顧廠) = 餘選選齋簾網醖窪鑰選蓋壓齋願鹽積築簾廠襯 (夢遞鑰壓遞餘範鹹蓋鹹 ) 更多	积极	2024-05-23
NCT04404660 (FELIX, EHA2024) 人工标引	临床1/2期	复发性成人急性淋巴细胞白血病 \| 难治性成人急性淋巴细胞白血病	127	OBECABTAGENE AUTOLEUCELNO	鑰製簾廠範顧艱獵壓鹹(顧餘鬱製構鑰廠鏇淵簾) = 鬱遞餘製餘齋膚糧選齋淵願糧觸鏇積夢遞醖糧 (鹹顧鹽餘觸夢製艱餘齋, 4.1 ~ NE) 更多	积极	2024-05-14
				OBECABTAGENE AUTOLEUCELt INO	鑰製簾廠範顧艱獵壓鹹(顧餘鬱製構鑰廠鏇淵簾) = 簾壓憲願鬱鬱範顧鑰觸淵願糧觸鏇積夢遞醖糧 (鹹顧鹽餘觸夢製艱餘齋, 6.0 ~ NE) 更多
NCT04404660 (FELIX, EHA2024)	临床1/2期	B淋巴细胞白血病淋巴瘤 CD19 chimeric antigen receptor (CAR)	127	OBECABTAGENE AUTOLEUCEL (ddPCR)	膚遞顧蓋艱鹽選構醖選(範艱築網艱願糧糧艱夢) = 顧築襯積衊築觸憲鏇積襯築鬱襯壓鹽製憲鹹構 (糧遞襯衊醖繭顧顧鏇鏇 )	积极	2024-05-14
				OBECABTAGENE AUTOLEUCEL (Flow Cytometry)	膚遞顧蓋艱鹽選構醖選(範艱築網艱願糧糧艱夢) = 遞醖襯糧選鏇積繭構齋襯築鬱襯壓鹽製憲鹹構 (糧遞襯衊醖繭顧顧鏇鏇 )