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+ [5]

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+ [15]

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

AGC Biologics A/S

+ [1]

非在研机构-

权益机构

UCL Business Ltd.

BioNTech SE

Autolus Therapeutics Plc

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

10

项与欧贝妥基奥仑赛相关的临床试验

NCT07053059

/ Not yet recruiting临床2期IIT

Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)

The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment.

开始日期2025-12-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT07053800

/ Not yet recruiting临床2期

A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis

This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to systemic lupus erythematosus (SLE)/lupus nephritis (LN) when available treatments have not worked (refractory). The trial includes only 1 group of patients (single arm), including teenage and adult patients aged 12 to 65 years. The objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after treatment in patients with severe, active LN. The trial will also look for other benefits of obe-cel for up to 24 months after treatment, including the percentage of patients who respond to obe-cel treatment, SLE/LN activity, time to and length of remission, and quality of life. The trial will also assess how long obe-cel stays in the body and the safety of obe-cel.

开始日期2025-09-01

申办/合作机构

Autolus Ltd.

[+1]

NCT07139743

/ Recruiting临床1期

A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants With Refractory Progressive Forms of Multiple Sclerosis

The main purpose of this study is to evaluate if obe-cel is safe or causes any side effects in adults with refractory progressive MS. The study also plans to assess if obe-cel can show early signs of efficacy in MS. The trial includes only 1 group of patients (single-arm). The study population comprises patients with progressive forms of MS, not responsive to highly effective therapies.
Upon confirmation of study eligibility, patients will receive fludarabine and cyclophosphamide (types of chemotherapy, used here for lymphodepletion) over 1 to 3 days in preparation for receiving a single obe-cel infusion.
Patients will be checked closely in the 28 days following obe-cel treatment. After this, patients will be monitored to evaluate safety and efficacy up to 24 months.

开始日期2025-08-04

申办/合作机构

Autolus Ltd.

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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41

项与欧贝妥基奥仑赛相关的文献（医药）

2025-08-03·Expert Review of Hematology

Obecabtagene autoleucel, a novel CD19-directed CAR T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia: the future for reducing toxicity and T-cell exhaustion?

Review

作者: Fromowitz, Ariel ; Yared, Jean A. ; Kocoglu, Mehmet ; Hardy, Nancy ; Rapoport, Aaron P. ; Atanackovic, Djordje

INTRODUCTION:

Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) continue to face poor outcomes despite recent advances in immunotherapy. The development of chimeric antigen receptor (CAR) T-cell therapies has transformed the treatment landscape, yet challenges such as severe cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and limited T-cell persistence have hindered their broader applicability. Obecabtagene autoleucel (obe-cel), a novel CD19-directed CAR T-cell therapy featuring a fast off-rate binding domain, represents a significant innovation aimed at optimizing the balance between efficacy and toxicity in this high-risk population.

AREAS COVERED:

This review examines the pharmacologic and clinical development of obe-cel, with a focus on the unique receptor design that mimics physiologic T-cell receptor interactions to mitigate overactivation and exhaustion. Data from early-phase and pivotal trials, particularly the FELIX phase Ib/II study, are discussed in detail, highlighting efficacy outcomes such as a 77% overall remission rate and favorable safety profile with low rates of grade 3 or higher CRS (2.4%) and ICANS (7.1%). A comprehensive literature search was conducted using PubMed and clinical trial databases to identify peer-reviewed publications, reports, ongoing studies, and regulatory updates relevant to obe-cel and comparable therapies in R/R B-ALL.

EXPERT OPINION:

Obe-cel represents an important conceptual advancement in CAR T-cell therapy, offering a promising alternative to existing high-affinity CD19 CARs. The integration of kinetic receptor engineering and split-dose administration appears to enhance both safety and durability of response, potentially redefining treatment goals in R/R B-ALL. As real-world experience and longer-term data accrue, obe-cel may emerge not only as a bridge to transplantation but also as a definitive therapy for select patients. The success of this approach may inform future CAR design across hematologic malignancies and support a paradigm shift toward receptor-tuned cellular immunotherapies.

2025-07-25·ANNALS OF HEMATOLOGY

Prophylactic Tocilizumab prior to infusion of CD19 CAR T-cells reduces therapy-related complications in older lymphoma patients.

Article

作者: Rieger, Max J ; Musa, Albulena ; Manz, Markus G ; Stolz, Sebastian M ; Zenz, Thorsten ; Bachofner, Adrian ; Gourri, Elise ; Bankova, Andriyana K ; Wolfensberger, Nathan ; Rösler, Wiebke ; Schneidawind, Dominik

CAR (chimeric antigen receptor) T-cell therapies have transformed treatment for relapsed and refractory B cell lymphomas (r/r BCL) and plasma cell myeloma. While real-world experiences have shown success across age groups, patients over 70 years require special attention due to therapy-related complications like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which can lead to adverse outcomes. This study analyzed outcomes of 26 r/r BCL patients aged ≥ 70 years treated with CAR T-cell therapy between 2019 and 2023, comparing those who received prophylactic Tocilizumab (N = 7) versus standard treatment (N = 19). The median age was 75 years, with patients having received a median of three prior therapy lines. Prophylactic Tocilizumab was given 1 h before re-transfusion of CAR T-cells. Patients receiving prophylactic Tocilizumab experienced significantly fewer therapy-related complications (p = 0.039) which were defined as one or more of the following events: severe CRS, severe ICANS, corticosteroid use, need for transfusions, treatment in a critical care unit, prolonged hospitalization and discharge to a care facility. Hospital stays in total were shorter in the Tocilizumab group (15.9 vs. 18.5 days), though not statistically significant. Progression-free and overall survival were similar between groups. The results suggest that prophylactic Tocilizumab may optimize management of older CAR T-cell patients, aligning with existing evidence regarding its prophylactic use in r/r BCL.

2025-06-01·Transplantation and Cellular Therapy

Awakening from REMS: ASTCT 80/20 Ongoing Recommendations for Safe Use of Chimeric Antigen Receptor T Cells

Review

作者: Mahmoudjafari, Zahra ; Kebriaei, Partow ; Locke, Frederick L ; Frigault, Matthew J ; Nikiforow, Sarah ; Perales, Miguel-Angel ; Gardner, Rebecca A ; Frey, Noelle V ; Komanduri, Krishna V

The first 6 chimeric antigen receptor T cell (CAR-T) therapies approved in the United States have Risk Evaluation Mitigation Strategies (REMS) programs mandated by the US Food and Drug Administration (FDA). REMS programs aim to ensure the safe use of CAR-T therapy through timely recognition and management of unique severe risks and toxicities that cannot be mitigated by labeling alone, such as cytokine release syndrome and neurotoxicity syndromes. At the launch of each of the first 6 products, CAR-T REMS programs mandated product-specific education and training for clinical staff, patients, and caregivers; adequate access to medications to treat expected toxicities; and reporting of toxicities either to the product manufacturer or to the FDA. Each manufacturer ensures that treatment centers comply with the REMS program for their individual product in different ways, involving time-consuming and often redundant training, testing, and audits. The American Society for Transplantation and Cellular Therapy (ASTCT) 80/20 Subcommittee convened its second workshop in June 2023, inviting approximately 70 cellular therapy stakeholders to discuss whether safety and quality workflows embedded in existing resources within the cellular therapy field could replace FDA-mandated and company-monitored REMS programs. Attendees were clinicians at large academic medical centers experienced in cellular therapy, regulators, members of accrediting bodies and professional societies, and manufacturers of immune effector cell (IEC) therapies at multiple stages of development. Discussion centered on (1) educational requirements for safe delivery and management, (2) goals and mechanisms for data reporting and to whom, and (3) what entities should oversee these quality safeguards around CAR-T administration and management. Broad support was voiced for (1) conducting training programs administered by treatment centers and/or professional societies to replace manufacturers' product training; (2) reporting standardized data points into a central, accessible repository for tracking of safety trends and identification of new signals; and (3) enabling accrediting bodies to attest to programs' quality and ongoing compliance with field safety expectations, thereby replacing intensive manufacturer initial evaluation and ongoing REMS audits. The strong consensus of the second multidisciplinary ASTCT 80/20 Workshop was that such measures would allow elimination, or at least significant reduction and simplification, of current CAR-T REMS programs. Development of educational resources and funding for data reporting outside of a mandated REMS structure were identified as critical, particularly to support treatment centers new to cellular therapy, as were ongoing collaborations with FDA and manufacturers. These consensus recommendations were shared with the FDA at the Cell Therapy Liaison Meeting and in multiple professional society meetings and other public forums with regulators, manufacturers, and FDA representatives. Recently the FDA scaled back several of the features of existing CAR-T REMS programs redundant to standard clinical practice, specifically requirements related to manufacturer-created training, product-specific testing of trained staff, and data reporting to manufacturers. The seventh commercial CAR-T product (Aucatzyl, or obecabtagene autoleucel) was the first approved without a REMS program as of November 8, 2024. Continued streamlining of already widespread CAR-T safety standards for existing and future approved CAR-T cells and other unique cellular therapy products and ensuring their adoption at new and existing treatment centers will be required to maintain and increase access to the ever-growing number of effective adoptive cellular therapies.

118

项与欧贝妥基奥仑赛相关的新闻（医药）

2025-08-15

·BioPharmaDive

Precigen wins immunotherapy approval; Pfizer sickle cell drug fails trial

Today, a brief rundown of news involving Precigen and Pfizer, as well as updates from the Institute for Clinical and Economic Review, Superluminal Medicines and Generation Bio that you may have missed.The Food and Drug Administration granted full approval to a first-of-its-kind treatment for recurrent respiratory papillomatosis, a rare and potentially life-threatening condition caused by persistent HPV infections. Thursdays clearance of PrecigensPapzimeos, an immunotherapy that helps clear HPV-infected cells, was based on study results showing a little more than half of drug recipients didn't need surgery within a year of therapy. Center for Biologics Evaluation and Research director Vinay Prasad, who rejoined the FDA this week, described the approval as proof randomized trials are not always needed to approve medical products. That statement should be reassuring to biotech investors concerned about stricter regulatory standards under Prasad, wrote Cantor Fitzgerald analyst Jennifer Kim. Precigen shares rose higher Friday on the news. Ben FidlerAn experimental Pfizer drug for sickle cell disease failed to meet its goal in a Phase 3 study, the company said Friday. Testing showed that treatment with inclacumab, a drug Pfizer acquired via its 2022 buyout of Global Blood Therapeutics, failed to significantly reduce versus placebo the pain crises people with sickle cell often experience. Pfizer said it would share analyses of the data with the scientific and patient community in due course. Last year, the company pulled from market another sickle cell drug, Oxbryta, that it gained from Global Blood, citing safety concerns. The company plans to provide updates on Oxbryta and a third Global Blood drug, the experimental osivelotor, when they become available. Ned PagliaruloEli Lilly will collaborate with biotechnology startup Superluminal Medicines to develop new drugs for cardiometabolic diseases and obesity. Through the alliance, the two intend to discover and advance small molecule medicines aimed at undisclosed G protein-coupled receptor, or GPCR, targets relevant to those conditions. Lilly will receive exclusive rights to the compounds emerging from the deal, while Superluminal could get up to $1.3 billion in total payouts, including an unspecified upfront payment as well as an equity investment, the companies said Thursday. Ben FidlerAutolus Therapeutics is delaying launching its leukemia cell therapy Aucatzyl in Europe following approval there as the company evaluates potential pricing and feasibility of market entry opportunities in some countries. Launch in Germany is on hold and Autolus does not anticipate any EU sales of Aucatzyl in 2025 and 2026, the company said in its second quarter earnings report. In the U.K., where Aucatzyl has also been approved, a government cost-effectiveness monitor has initially decided not to pay for it. Autolus said it will continue to work towards a pathway for patient access to therapy in the U.K. Approved by the Food and Drug Administration in November 2024, Aucatzyl earned just shy of $30 million in sales in the first six months of 2025, all from the U.S. Jonathan GardnerGeneration Bio revealed preclinical results suggesting a delivery technology its developing can effectively send nucleic acid payloads into T cells. But the company also said this week that it may not be able to raise the funds to prove that approach works in humans and, as a result, began a strategic review that could end in a sale or merger. Generation will lay off roughly 90% of its workforce, including all of its research and development staff, by the end of October. Company shares climbed 60%, though theyve lost much of their value since the companys initial public offering in 2020. Ben Fidler '

上市批准免疫疗法临床3期细胞疗法并购

2025-08-13

·EndPoints

Autolus says it won’t make money from its cell therapy in Europe until 2027

Despite a recent approval in Europe, Autolus Therapeutics does not expect to sell its blood cancer cell therapy in the region until 2027 and specifically noted that its German launch plans are on hold. The CD19-targeted cell therapy called Aucatzyl was greenlit by the European Commission for relapsed or refractory B cell precursor acute lymphoblastic leukemia last month, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May. However, the biotech doesn’t anticipate any European sales this year or next, as the path to market access in Europe often requires data from randomized controlled studies. This presents a challenge for therapies like its cell therapy, which were evaluated in single-arm registrational trials, Autolus CEO Christian Itin said on a Tuesday earnings call with analysts. The company’s share price $AUTL was down about 12% at market close Tuesday. Autolus said it is currently assessing “pricing and feasibility of market entry opportunities” in EU states. “We’re going to do this very methodically, going to go through country by country,” Itin said. The company has put its planned German launch on pause to allow more time for engagement with physicians, patient bodies and regulators there. Itin added that the Trump administration’s calls for a “most favored nation” approach to drug pricing in the US could also “create tension that may or may not be helpful” for Autolus’ efforts in Europe. Aucatzyl was also approved by the UK’s Medicines and Healthcare products Regulatory Agency in April. But the country’s cost-effectiveness watchdog, the National Institute for Health and Care Excellence, has made a preliminary recommendation against reimbursing the treatment. Nonetheless, the therapy is enjoying some momentum in the US, where it made $20.9 million in Q2. The figure beat Wall Street consensus estimates of $14.1 million, Jefferies analysts said. The treatment has had a “very, very positive reception” from the US medical community, Itin told analysts. Its strong “safety profile and manageability” has encouraged centers to reorder doses “very early on,” he added. Aucatzyl won FDA approval in November 2024. It is given in two doses around ten days apart and has a list price of $525,000. Autolus said it has secured Aucatzyl coverage for more than 90% of total US medical lives so far. As of Aug. 12, 46 centers across the country were administering the treatment. The biotech plans to expand to 60 or more centers by the end of the year, Itin said.

细胞疗法上市批准免疫疗法

2025-07-31

·Business Wire

European Commission Approves CAR-T Therapy With Lentiviral Vectors Manufactured by AGC Biologics

MILAN--(BUSINESS WIRE)--Following news on July 21 that the European Commission has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel – obe-cel), AGC Biologics’ Milan site achieved its 10th product approval from the European Medicines Agency or the U.S. Food and Drug Administration. Developed by Autolus Therapeutics, AUCATZYL® is now approved to treat adult patients (age 26 and older) in 27 European Union member states with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This follows the therapy’s prior authorizations from the FDA in November 2024 and the U.K. Medicines and Healthcare products Regulatory Agency in April 2025. This latest step further solidifies AGC Biologics’ Milan Cell and Gene Center of Excellence’s reputation as a global leader in the field, built on a 30-year track record of quality, reliability, and regulatory success. “This European approval for Autolus is a milestone we are thrilled to be part of. Our goal is to be the industry’s safe harbor: a trusted, friendly expert CDMO that de-risks the complex path to commercialization,” said Alberto Santagostino, CEO and President, AGC Biologics. “By ensuring a reliable supply of their vital lentiviral vector, we empower our partners to focus on patients. Congratulations to the entire Autolus team.” The partnership between Autolus and AGC Biologics Milan began in 2020, with the CDMO tasked to develop, manufacture, and supply the viral vectors for Autolus’ obe-cel CAR-T product candidate. “From the start of our partnership in 2020, through the FDA approval and now this European authorization, our collaboration with Autolus has been a model of true partnership,” said Luca Alberici, General Manager, AGC Biologics Milan. “The team’s sustained dedication and technical excellence is a direct result of our ability to work seamlessly with the Autolus team to meet the demands of commercial-scale manufacturing for a global market.” With its 30-year track record and 10 product approvals by the EMA and FDA, the AGC Biologics Milan site is a global leader with deep expertise in complex cell and gene therapy projects. The team has guided numerous products to commercial stages, manufactured hundreds of batches for clinical supply, and consistently met the highest global regulatory guidelines, quality performance metrics, and the unique complexities of technology transfers and manufacturing scale-up. To learn more about AGC Biologics’ global cell therapy services, visit www.agcbio.com/capabilities/cell-therapy, and for more on the CDMO’s viral vector offerings, visit www.agcbio.com/capabilities/viral-vector. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. AUCATZYL® (obecabtagene autoleucel – obe-cel) is a registered trademark of Autolus Therapeutics.

上市批准细胞疗法免疫疗法基因疗法

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

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
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
狼疮性肾炎	临床2期	-	Autolus Ltd.	2025-09-01
急性淋巴细胞白血病	临床2期	美国	Autolus Ltd.	2020-06-03
急性淋巴细胞白血病	临床2期	西班牙	Autolus Ltd.	2020-06-03
急性淋巴细胞白血病	临床2期	英国	Autolus Ltd.	2020-06-03
费城染色体阳性急性淋巴细胞白血病	临床2期	美国	Autolus Ltd.	2020-06-03
费城染色体阳性急性淋巴细胞白血病	临床2期	西班牙	Autolus Ltd.	2020-06-03
费城染色体阳性急性淋巴细胞白血病	临床2期	英国	Autolus Ltd.	2020-06-03
慢性进行性多发性硬化	临床1期	英国	Autolus Ltd.	2025-08-04

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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, ASCO2025)	临床1/2期	复发性 B 细胞急性淋巴细胞白血病 CD19	127	Obe-cel	醖壓壓糧鹽願壓製鏇醖(糧蓋構顧衊積網遞窪簾) = 淵積淵獵餘壓遞壓選鬱夢積製膚選鏇廠鬱積膚 (艱齋壓願積鬱網窪襯簾, 60.9 ~ 81.7)	积极	2025-05-30
				obecabtagene autoleucel (obe-cel) (Age <55 years)	醖遞壓顧鹹窪壓淵遞鏇(窪築壓餘鏇網願範夢鑰) = 選廠積鏇構網窪選艱膚蓋餘壓繭構蓋觸憲築衊 (醖積廠積獵積鑰糧鹹獵 ) 更多
NCT04404660 (FELIX, EHA2025)	临床1/2期	难治性 B 细胞急性淋巴细胞白血病 CD19	127	Obe-cel <55 years	鏇壓簾構鹹顧鏇鑰蓋廠(膚糧網觸選廠構鹹夢壓) = 鏇網糧願廠繭選艱憲鏇獵鬱製築製艱窪範艱簾 (淵構製獵蓋淵鑰製齋構 ) 更多	积极	2025-05-14
				Obe-cel ≥55 years	鏇壓簾構鹹顧鏇鑰蓋廠(膚糧網觸選廠構鹹夢壓) = 夢鏇網艱淵餘構夢廠顧獵鬱製築製艱窪範艱簾 (淵構製獵蓋淵鑰製齋構 ) 更多
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)	膚糧鏇範繭鹽鬱夢壓簾(醖淵構觸積壓鬱壓願鏇) = 壓簾繭廠鹹築窪憲願衊繭網夢齋簾築鏇鑰鬱齋 (鑰夢選網夢衊餘觸構壓, 34.6 ~ 55.6) 更多	-	2024-12-09
				Obecabtagene autoleucel (obe-cel) (Low-risk HT score)	膚糧鏇範繭鹽鬱夢壓簾(醖淵構觸積壓鬱壓願鏇) = 鬱鏇夢齋積鹽顧憲製顧繭網夢齋簾築鏇鑰鬱齋 (鑰夢選網夢衊餘觸構壓, 40.2 ~ 82.1) 更多
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	艱鏇衊鹽淵糧範齋齋遞(鹽獵網鏇製簾鬱繭簾範) = 範鹽製鬱齋膚膚淵艱簾蓋醖遞廠觸壓觸鑰壓衊 (蓋簾鹽鏇膚艱襯鏇憲糧 ) 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)	範膚遞願淵衊壓蓋壓鹹(窪衊製齋範製選積廠膚) = 72 (70.6%) were CRS only 觸鹹蓋觸製廠廠製構鬱 (醖窪鏇蓋遞願製願顧衊 ) 更多	积极	2024-12-09
ASH2024	N/A	复发性成人急性淋巴细胞白血病	-	Bridging Therapies with Inotuzumab Ozogamicin (INO)	積鹽艱窪衊網衊顧醖醖(製餘鏇廠製築網襯夢夢) = 製積糧憲鹽鑰繭鑰醖鬱憲齋窪獵鬱繭鬱窪艱糧 (壓廠遞選餘蓋簾簾鏇齋, 4.1 ~ NE) 更多	-	2024-12-08
				Bridging Therapies without Inotuzumab Ozogamicin (INO)	積鹽艱窪衊網衊顧醖醖(製餘鏇廠製築網襯夢夢) = 壓簾觸顧範淵獵艱艱襯憲齋窪獵鬱繭鬱窪艱糧 (壓廠遞選餘蓋簾簾鏇齋, 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)	壓鬱繭鏇壓鑰鹽憲製窪(積醖鏇選範製構淵廠壓) = 糧蓋糧願顧積膚壓壓膚淵顧鹹簾鹽願獵製網鹽 (構蓋簾鹹鹽簾構製夢餘, 50 ~ 75) 更多	积极	2024-11-08
				AUCATZYL (All Leukapheresed)	壓鬱繭鏇壓鑰鹽憲製窪(積醖鏇選範製構淵廠壓) = 願範齋餘製衊夢顧範壓淵顧鹹簾鹽願獵製網鹽 (構蓋簾鹹鹽簾構製夢餘, 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)	築繭鏇艱積夢鬱鬱鑰餘(築壓鏇膚鏇鏇繭壓齋顧) = 淵壓窪醖鹽鹹艱夢壓夢觸觸壓膚簾築築觸積構 (顧襯選淵壓襯襯構蓋壓, 1.527–2.802) 更多	积极	2024-09-04
				Obecabtagene Autoleucel (Obe-Cel) (High TB)	醖蓋夢窪製窪餘積窪選(網範壓遞衊衊範蓋齋醖) = 選築顧願廠簾壓遞蓋窪鹹襯積獵襯糧齋網遞簾 (襯觸壓糧餘選醖襯糧網 ) 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	糧選夢衊繭糧範製簾襯(選範獵餘窪築憲衊網構) = Pts who experienced B-cell recovery had a hazard risk of relapse or death 1.7 times compared with pts without B-cell recovery 觸襯鏇憲選選衊鹹願夢 (艱餘壓鏇廠鹽顧糧艱衊 ) 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)	網糧繭簾鑰夢鹹衊製選(構窪齋築齋壓鑰繭餘積) = 觸壓蓋膚鏇範襯觸選齋顧獵淵構膚憲憲觸遞鬱 (膚壓願糧膚艱壓淵衊鬱 ) 更多	积极	2024-05-23