Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy

This phase II MyeloMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.

开始日期2026-06-18

申办/合作机构

National Cancer Institute

NCT07476729

/ Not yet recruiting临床3期IIT

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

The IntReALL BCP 2020 study aims to review recent developments and findings regarding chemoimmunotherapy with inotuzumab and immunotherapy with blinatumomab and to increase the use of promising new immunotherapeutic drugs as replacements for toxic SOC chemotherapy elements.
The IntReALL BCP 2020 study has the potential to improve CR and EFS rates for all SR and HR groups, as well as for patients with IEM recurrence, by replacing toxic chemotherapy with targeted, less toxic immunotherapy strategies, and could establish these new approaches as SOC for children with relapsed BCP ALL in the future.

开始日期2026-04-01

申办/合作机构-

NCT06863259

/ Recruiting临床1期IIT

A Phase 1 Study With a Pilot Expansion Phase of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) for Relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL)

The goal of this clinical trial is to learn if the combination of drugs Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) are safe to treat relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) in pediatric and adult patients. It will also learn if these drugs are well tolerated. The main questions it aims to answer are:
Is the drug combination of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) safe when given to patients?
What medical problems do patients taking IoVeX experience?
Participants will:
Receive this combination of drugs for 1 cycle which is 28 days at various timepoints. If participants tolerate cycle 1 they will be eligible to continue to cycle 2 which is also 28 days.
Have checkups and tests at the beginning of the study and throughout the course of each cycle.

开始日期2025-05-21

申办/合作机构

Children's Hospital & Medical Center

100 项与奥加伊妥珠单抗相关的临床结果

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100 项与奥加伊妥珠单抗相关的转化医学

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100 项与奥加伊妥珠单抗相关的专利（医药）

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387

项与奥加伊妥珠单抗相关的文献（医药）

2026-12-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

The Use of Targeted Therapy in Pediatric Acute Lymphoblastic Leukemia: Exploring Novel Approaches and Emerging Therapies

Review

作者: Krieger, Marissa ; Byrwa, David J ; Kelly, Kara M ; Niswander, Lisa M

Opinion Statement:

With modern risk stratification of multi-agent cytotoxic chemotherapy protocols, we now cure the majority of patients with pediatric acute lymphoblastic leukemia (ALL). However, patients with high-risk features or relapsed disease continue to have suboptimal outcomes. Conventional chemotherapy agents may increase long term organ toxicities even in more favorable patients. Improved understanding of the molecular characteristics of pediatric ALL has led to the preclinical and clinical development of more targeted and less systemically toxic therapeutic options for patients with ALL. Agents such as blinatumomab, inotuzumab ozogamicin, tisagenlecleucel and several others have revolutionized the treatment of relapsed or refractory ALL by either directing therapies locally to leukemic cells or by targeting specific leukemogenic pathways. Here we present current evidence for efficacy and toxicity profiles for these targeted therapies in pediatric patients with ALL. Many of these strategies have been more comprehensively studied in the adult population and we will highlight ongoing and needed clinical trials in pediatrics. We need to overcome our historically delayed approach to introducing new therapeutic options in pediatrics, as adults often benefit from innovations for years before they are evaluated in children. More proactively incorporating these emerging treatments into frontline therapy for the most vulnerable, high-risk pediatric ALL populations could meaningfully reshape our treatment paradigm. Earlier collaboration for development of clinical trials across pediatric and adult ALL may facilitate more rapid access to promising agents. We anticipate that successful upfront integration of more targeted approaches will improve response rates, reduce reliance on highly toxic chemotherapies and ultimately increase the likelihood of duration of remission. We expect the next generation of clinical trials will credential more targeted therapies for use in frontline therapy with the goal of improved outcomes with minimized toxicity for all patients with pediatric ALL, not just those with more favorable disease characteristics.

2026-05-01·LEUKEMIA

Characteristics and outcome determinants in children, adolescents and young adults who failed tisagenlecleucel for B-cell acute lymphoblastic leukemia

Article

作者: Lecornec, Nicolas ; Arnould, Anne ; Kim, Rathana ; Larghero, Jérôme ; Chaillou, Delphine ; Roupret-Serzec, Julie ; Caye-Eude, Aurélie ; Dourthe, Marie-Emilie ; Caillat-Zucman, Sophie ; Guérin-El Khourouj, Valérie ; Arfeuille, Chloé ; Chaix, Marie-Laure ; Mathis, Stéphanie ; Parquet, Nathalie ; Madelaine, Isabelle ; Lesprit, Emmanuelle ; Yakouben, Karima ; Naudin, Jérôme ; Baruchel, André ; Clappier, Emmanuelle ; Chevillon, Florian ; Brignier, Anne ; Cuffel, Alexis ; Azoulay, Elie ; Dalle, Jean-Hugues ; Rabian, Florence ; Boissel, Nicolas ; Lainey, Elodie

Tisagenlecleucel (tisa-cel), an autologous anti-CD19 CAR T-cell therapy, has significantly improved outcomes in pediatric, adolescents and young adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R BCP-ALL). However, 30-50% experience early failure or relapse. We retrospectively analyzed 52 cases of early failures (n = 13) or relapses (n = 39), evaluating post-tisa-cel outcomes and prognostic factors. CD19 antigen loss was the only factor associated with a lower complete remission rate after salvage therapy (OR = 0.16, 95%CI [0.03-0.90], p = 0.04). Median overall survival (OS) was 14.5 months, with a 2-year OS of 37.4% (95%CI [24.4-50.4]), similar between early failure (38.5%) and relapse (37.0%) groups (p = 0.78). Patients with measurable residual disease only at salvage initiation had significantly improved 2-year OS (61.9%, (95%CI [38.1-78.8])) compared to those with overt disease (20.7%, (95%CI [8.4-36.7], p = 0.008)). Factors associated with inferior OS included high pre-infusion tumor burden (HR = 3.57, p < 0.01), and prior inotuzumab ozogamicin exposure (HR = 3.81, p < 0.01). Although salvage therapies and hematopoietic stem cell transplantation benefit some patients, 5 of 18 transplanted patients died from treatment-related toxicity, underscoring the significant associated risks. These findings highlight the poor prognosis of tisa-cel failures and the urgent need for novel strategies.

2026-05-01·Journal of medical cases

Secondary Philadelphia Chromosome–Negative B-Cell Acute Lymphoblastic Leukemia Following Prolonged Lenalidomide Maintenance in Multiple Myeloma

Article

作者: Thomas, Jessica ; Anyadibe, Afoma ; Jaiyesimi, Ishmael ; Tai, Waqqas ; Oyetoran, Anuoluwa ; Khan, Sarang ; Ammakola, Yagnapriya

Lenalidomide maintenance significantly improves survival in multiple myeloma (MM) but increases the risk of second primary malignancies (SPMs), with the most common hematologic SPMs being myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Secondary B-cell acute lymphoblastic leukemia (B-ALL) is rare. We describe a 62-year-old woman diagnosed with immunoglobulin G lambda MM with extramedullary disease. She achieved remission following induction with lenalidomide, carfilzomib, and dexamethasone, followed by autologous stem cell transplantation. Lenalidomide maintenance was continued for over 4 years, then discontinued due to fatigue. Nearly 1 year later, she presented with bruising and thrombocytopenia. Bone marrow biopsy confirmed Philadelphia chromosome-negative B-ALL with a complex karyotype. She achieved remission with mini-hyper-CVD (cyclophosphamide, vincristine, dexamethasone) plus inotuzumab ozogamicin and rituximab, followed by allogeneic transplantation. This case illustrates lenalidomide-associated B-ALL as a rare late complication of maintenance therapy in MM, underscoring the need for vigilance and early diagnostic evaluation.

267

项与奥加伊妥珠单抗相关的新闻（医药）

2026-05-15

·PKsim学习笔记

CPK | ADC定量药理建模策略：单分析物、双分析物还是三分析物？

PK-Sim学习笔记 📄 论文题目： Application of Pharmacometrics in Advancing the Clinical Research of Antibody-Drug Conjugates: Principles and Modeling Strategies 👤 作者： Xiuqi Li, Dan Liu, Shupeng Liu, et al. 📚 期刊： Clinical Pharmacokinetics (2024) 🔗 DOI： 10.1007/s40262-024-01423-x B2 ADC的结构复杂，包含抗体、Linker、Payload，加上药物抗体比(DAR)异质性，导致体内存在多个分析物（结合抗体、总抗体、游离Payload）。建模时到底该测什么、建几个分析物？这篇来自北京协和医院临床药理研究中心的综述，系统总结了已发表的52篇ADC PopPK模型，把它们分为单、双、三分析物三类，并结合实例讲清楚了各自的适用场景和取舍。对于正在做ADC建模的同行来说，这是一篇可以直接当工具书参考的文章。研究背景 ADC的PK比普通单抗复杂得多。除了抗体本身的靶点介导清除（TMDD）和非特异性清除，还有Linker断裂释放Payload的过程。Payload可能在循环中提前释放，也可能在肿瘤细胞内释放后产生bystander effect。同时，DAR在不同ADC分子上分布不均，每个抗体上挂的Payload数量不同，导致“结合抗体”是一个混合物，不同DAR组分的PK可能不同。这些复杂性导致生物分析方法需要区分多种分析物：总抗体（识别所有含抗体的分子）、结合抗体（至少携带一个Payload的抗体）、游离Payload。但临床样本中，游离Payload往往浓度很低，低于检测下限。研究人员因此面临一个问题：到底用哪个分析物建PopPK模型？单分析物够不够？什么时候需要多分析物？这篇综述的核心目标就是回答这个问题，梳理已有ADC PopPK模型，总结三类建模策略的优缺点，并提出选择模型时需要考虑的四个关键因素。方法与模型研究人员检索了PubMed上2012-2024年间的ADC定量药理学文献，最终纳入52篇，按模型类型分为PopPK、PK/PD、PBPK和E-R。其中PopPK占了30篇，是最多的。他们对这30篇PopPK模型进行了归类分析，总结出三类建模方法。单分析物模型这类模型只选择一个分析物建模，绝大多数选的是结合抗体（其实也叫偶联抗体）。选择理由：结合抗体在临床前的数据显示与疗效和安全性的相关性往往最强，而且游离Payload浓度经常测不到。一个典型例子是T-DM1（trastuzumab emtansine）的PopPK模型。Gupta等人整合了三项临床试验共273例HER2阳性乳腺癌患者数据，最终采用二室线性模型，一级消除，没有靶点介导清除。这就是典型的“简单即有效”场景，在临床剂量范围内，T-DM1的PK是线性的。研究人员还评估了体重、白蛋白、谷草转氨酶、肿瘤负荷等协变量：体重对AUCSs的影响在-19%到+24.1%之间，支持了基于体重给药的方案；其他协变量影响很小。另一个例子是Inotuzumab ozogamicin（CD22靶向ADC），同样采用二室线性模型，不过这里多了一步，在清除中加入了时间依赖的CL因素，因为观察到随治疗时间增加，清除会变快（可能跟靶点饱和度变化有关）。这算是在单分析物框架下引入了一些机制元素。研究人员指出，单分析物模型的优势是结构简单、数据需求低，适合早期或数据有限的阶段。但局限性也很明显：无法捕捉ADC结构异质性对PK的影响，也无法关联Payload暴露与安全性。其实个人觉得这类型的建模跟普通的mAbs的建模差不多，是最简单的一种处理方式，如果满足选择理由，大家可以偏好选取结合抗体进行建模，比如当研究目标是总体 PK 描述，且早期体外/动物证据提示偶联抗体暴露与疗效安全性关系清晰，或游离载荷长期低于检测下限、临床信息采集受限时，单分析物模型往往足够。双分析物模型这类模型同时建模两个分析物，常见组合有两种：结合抗体+游离Payload，或结合抗体+总抗体。以Brentuximab vedotin为例，研究团队建立了结合抗体和游离MMAE（payload）的联合模型。结合抗体用二室线性模型描述，游离MMAE用一室模型，同时加入了一个从结合抗体到游离MMAE的“脱靶”释放速率常数。这样就能同时预测结合抗体的清除和Payload的生成与消除。通过这种双分析物模型，可以模拟不同给药方案下的Payload暴露，从而优化剂量和给药间隔。双分析物模型的优势在于能描述Payload的生成过程，便于进行E-R分析和安全性评估。但代价是需要同时测量两种分析物的浓度数据，而且在结构可辨识性上可能存在问题（“偶联抗体”与“总抗体”常高度相关），比如Payload的生成速率常数和清除速率常数可能相关性很强，需要数据支撑。三分析物模型三分析物模型同时包含结合抗体、总抗体和游离Payload。这类模型最复杂，因为引入了一个新的中间变量，未结合Payload的裸抗体。研究人员以Trastuzumab deruxtecan (T-DXd) 为例：模型假设总抗体=结合抗体+裸抗体。结合抗体通过一级释放速率产生游离Payload和裸抗体，裸抗体继续被清除。这样，总抗体和结合抗体的PK曲线可以分离，从而推断出DAR随时间的变化。三分析物模型的优势是提供了对ADC体内完整行为的描述，能推断DAR动态变化—，这是理解ADC“有效载荷递送效率”的关键。但缺点同样明显：需要三个分析物的全部数据，且模型参数多，可辨识性挑战巨大。目前这类模型的报道很少，应用场景有限。选择模型的四个关键因素论文提出了一个非常重要的框架：选择PopPK模型策略时，应从四个维度系统考量。第一，研究目的。如果主要目的是支持剂量选择，单分析物结合抗体模型可能就够了，因为疗效主要跟结合抗体相关。但如果需要解释安全性与Payload暴露的关系，就必须考虑双分析物甚至三分析物模型。第二，可用的体外和动物数据。如果已有动物PK数据表明Payload在体内稳定、游离浓度始终低到无法检测（比如某些不可切割Linker的ADC），那单分析物模型可能是唯一选择。反之，如果动物数据显示Payload有显著的循环暴露，那必须考虑Payload建模。第三，临床数据的可获取性。如果临床试验中只测量了结合抗体（比如早期阶段为了节省成本），那就只能用单分析物模型。但随着研究推进，建议增加Payload和总抗体的测量。第四，生物分析方法的能力。能不能区分总抗体和结合抗体？能不能测到超低浓度的Payload？这直接决定了多分析物模型是否可行。这个框架很实用，相当于一个决策树。研究团队可以事先用这个框架评估该建什么模型，而不是拿到数据后盲目尝试。核心结果研究人员归纳了以下几项关键发现：单分析物模型仍是主流：在30篇PopPK文献中，大多数采用单分析物（结合抗体）建模，且多为二室线性模型。这些ADC的PK在治疗剂量范围内通常呈线性，TMDD效应不明显，可能因为临床目标浓度往往远高于靶点饱和阈值。双分析物模型开始被用于安全性评估：特别是在Payload已知有毒性（如MMAE）的ADC中，建立Payload生成与清除模型来预测最大浓度Cmax或AUC，从而设定安全剂量上限。三分析物模型尚在探索阶段：只有少数案例，且多基于早期临床数据。论文没有展示太多具体的参数估计结果，更多是概念验证性。协变量效应方面：体重是影响ADC PK最常见的协变量，其次是白蛋白、肝功能指标和肿瘤负荷。但多数协变量效应幅度在±20%以内，临床意义有限。一个重要案例：Gemtuzumab ozogamicin曾被撤市后通过PopPK和E-R分析重新获批。这是定量药理学在ADC领域的标志性成功案例。研究团队通过模拟找到了最优方案（分次给药降低毒性），证明了建模的价值。讨论与启发这篇综述很务实，没有强行推销复杂模型。我的理解和评论如下：关于单分析模型的局限性，论文说得比较含蓄。实际上，只建结合抗体的模型意味着忽略了ADC的“药物递送效率”差异。两个ADC结合抗体PK完全一样，但一个Linker稳定，一个不稳定，安全性可能天差地别。单分析物模型无法捕捉这个差异。所以在安全性驱动的场景下，双分析物建模几乎是必须的。研究人员提出四个关键因素非常务实，但操作层面仍有挑战。比如“临床数据的可获取性”，早期的phase I往往只测总抗体（因为方法开发简单），等到后来发现需要区分结合抗体时，已经来不及补数据了。所以实践中的建议是：在临床开发计划中尽早纳入多种分析物测定，哪怕只是按批次检测，也比没有好。关于模型结构，论文总结的ADC PopPK大多是线性二室，这与其他生物药的PK习惯一致。但有一点值得注意：部分ADC存在“去缀合速率”随着时间增加的现象（比如Inotuzumab ozogamicin），这可能与靶点负荷降低或免疫反应有关。如果忽略这一点，可能会高估稳态暴露。三分析物模型的理论很美，但可用性存疑。参数太多、可辨识性差，且需要精密的生物分析方法来区分裸抗体与结合抗体。目前多数实验室的常规方法还做不到这一点（通常总抗体和结合抗体用不同ELISA，裸抗体是计算出来的）。期待未来质谱技术能直接测定DAR分布，那样三分析物模型的输入数据质量会大幅提升。最后，这篇综述没有涉及PBPK Modeling。实际上，PBPK在ADC中的应用也有不少文献，但作者主要是聚焦PopPK。对于这种Review，聚焦一点说清楚比什么都谈要好。参考资料 [1] Li X, Liu D, Liu S, et al. Application of Pharmacometrics in Advancing the Clinical Research of Antibody-Drug Conjugates: Principles and Modeling Strategies. Clinical Pharmacokinetics, 2024, 63: 1373-1387. 扫码添加好友 PK Sim学习笔记

2026-05-15

·allsci.com

Allterum’s anti-CD127 mAb 4A10 enters Phase I for relapsed/refractory acute lymphoblastic leukemia

Allterum Therapeutics is advancing 4A10, a fully human anti-CD127 IgG1 monoclonal antibody licensed from the National Cancer Institute, into a first-in-human clinical trial in adults with relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma, marking the first time the compound will be tested in humans after receiving US FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations. The Phase I study (NCT07586618) is an open-label, single-arm, 3+3 dose-escalation monotherapy trial enrolling approximately 24 adults with confirmed T-cell or B-cell ALL or lymphoblastic lymphoma who have relapsed or become refractory to prior therapy and have no remaining curative options. The trial is conducted at Texas Children’s Hospital in Houston, with Eric Schafer, MD, of Baylor College of Medicine serving as study chair. According to the trial record, the study was not yet recruiting as of May 2026, with a primary completion date of May 2028. The primary objectives are to establish the recommended Phase II dose and to characterize the safety profile of 4A10 monotherapy through assessment of treatment-emergent adverse events at each dose level, graded according to CTCAE version 6. Patients receive 4A10 by intravenous infusion once weekly in 28-day cycles, with treatment continuing for up to six cycles in the absence of disease progression or unacceptable toxicity. Secondary endpoints include pharmacokinetic parameters as well as preliminary anti-tumor activity measures such as complete remission rate, complete remission with incomplete hematologic recovery, measurable residual disease negativity among responders, and the rate of patients proceeding to hematopoietic stem cell transplantation following treatment. The trial excludes patients with CNS3 disease, DNA fragility syndromes such as Fanconi anemia or Bloom syndrome, trisomy 21, prior exposure to anti-CD127 therapies, and uncontrolled infections. The inclusion of both T-cell and B-cell disease subtypes across the single escalation arm reflects the broad CD127 expression profile that underpins the program’s rationale. Biological rationale and the CD127 target CD127, the alpha subunit of the interleukin-7 receptor (IL-7Rα), functions as a shared component of two distinct receptor complexes: the IL-7 receptor, formed with the common gamma chain, and the thymic stromal lymphopoietin receptor (TSLPR). Both complexes are expressed on T-ALL and B-ALL cells, and IL-7 signaling through CD127 has been implicated in leukemic cell survival and resistance to chemotherapy. By binding IL-7Rα, 4A10 acts as a receptor antagonist, blocking IL-7-induced pro-survival signaling, while its IgG1 Fc region engages immune effector cells to drive antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis against CD127-expressing leukemic cells, according to company press releases. 4A10 was invented by Scott K. Durum, PhD, a senior investigator in the Cytokine and Immunity Section at the NCI Center for Cancer Research, and subsequently licensed exclusively to Fannin, a Houston-based life sciences commercialization firm, which then assigned the license to Allterum Therapeutics upon the company’s formation as a Fannin spin-out. Allterum has since received support from the NCI’s Experimental Therapeutics (NExT) Program, an approximately USD 1 million NCI SBIR grant, and more than USD 20 million in grants from the Cancer Prevention Research Institute of Texas (CPRIT), which is also listed as a trial collaborator alongside the NCI. The US FDA cleared Allterum’s investigational new drug application for 4A10 in October 2025, according to a company press release. Competitive landscape CD127 has attracted limited clinical-stage attention relative to more established ALL targets such as CD19, CD22, and CD3-engaging bispecifics. The most directly comparable clinical program in this mechanistic class is the anti-IL-7Rα antibody program pursued by OSE Immunotherapeutics, whose candidate lusvertikimab (OSE-127) has been evaluated in inflammatory indications including ulcerative colitis and primary Sjögren’s syndrome rather than in hematologic malignancies, reflecting a different therapeutic application of CD127 blockade. No other anti-CD127 monoclonal antibody appears to have entered clinical testing in ALL or lymphoblastic lymphoma based on publicly available information, which would make 4A10 a potential first-in-class agent for this indication if that status is confirmed. In the broader relapsed or refractory ALL space, the competitive reference points are blinatumomab (Amgen, approved), a CD19/CD3 bispecific T-cell engager, and inotuzumab ozogamicin (Pfizer, approved), a CD22-targeted antibody-drug conjugate, both of which are established in B-cell ALL. For T-cell ALL specifically, approved targeted options remain more limited, which is one factor that may inform the design of this trial to include both lineages. The mechanistic distinction of 4A10 — direct receptor antagonism combined with Fc-mediated immune killing at a target not addressed by any currently approved ALL therapy — is the key differentiation the company is advancing into human testing, though no clinical data yet exist to evaluate whether this translates to meaningful anti-leukemic activity. Primary completion of the trial is anticipated in May 2028, with overall study completion expected by September 2028, according to the trial record. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. AllSci Corp. All rights reserved.

2026-05-14

·ioncology

EHA 2026 速递丨立足临床，融汇所长，陆道培医学团队携13项研究成果登国际学术舞台

点击蓝字关注我们 2026年第31届欧洲血液学会年会（EHA）将于6月11日至14日在瑞典斯德哥尔摩盛大召开。作为全球血液学领域最具影响力的学术会议之一，EHA年会每年都汇聚顶尖专家、学者及行业领袖，共同分享和探讨有关血液学的创新理念及基础与临床研究成果，本届EHA年会将围绕白血病、淋巴瘤、骨髓瘤、造血干细胞移植及细胞治疗等核心方向，集中发布最新临床研究成果与前沿进展。本届会议，陆道培医学团队有13项研究成果入选，其中1项Oral（口头）报告、12项Poster（墙报）展示，充分展现了团队在细胞治疗与造血干细胞移植领域的持续创新能力与国际影响力。多年来，陆道培医学团队始终以患者需求为导向，持续深耕复发难治血液肿瘤这一核心临床难题。依托大规模临床实践与规范化管理体系，陆道培医学团队已在细胞治疗与移植领域形成系统化优势，持续产出具有国际影响力的高质量研究成果。同时，随着诊疗水平与国际影响力的不断提升，越来越多国际患者跨越国界，慕名来到陆道培医院寻求治疗，这既是对医疗实力的认可，也见证着中国血液学走向世界的步伐。口头报告（ORAL） 01 第一作者：张弦，通讯作者：张弦题目：Long-Term Outcomes of Naturally Selected CD7 CAR-T Therapy in Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma: A Cohort of 171 Patients 血液科主任（副院长级）张弦墙报展示（POSTER） 01 第一作者：张弦，通讯作者：陆佩华题目：CTD402 Allogeneic Anti-CD7 CAR T-Cell Therapy is Safe and Effective in Adolescent/Pediatric Patients (pts) with Relapsed/Refractory (R/R) T-ALL/LBL 陆道培医院医疗院长陆佩华血液科主任（副院长级）张弦 02 第一作者：张改玲，通讯作者：张弦题目：Inotuzumab Ozogamicin as Salvage Therapy for Heavily Pretreated R/R B-ALL: Bridging to Transplantation Drives Survival Benefit 血液科主任（副院长级）张弦血液科副主任医师张改玲 03 第一作者：王昀，通讯作者：卢岳题目：Allogeneic Hematopoietic Stem Cell Transplantation for Childhood B-ALL with TCF3::PBX1: A Retrospective Analysis of 70 Patients from a Single Center 造血干细胞移植科主任（副院长级）卢岳造血干细胞移植科副主任医师王昀 04 第一作者：张雪双，通讯作者：卢岳题目：Prognostic Analysis of Allogeneic Hematopoietic Stem Cell Transplantation in ZNF384-Rearranged Acute Leukemia: A Single-Center Study 造血干细胞移植科主任（副院长级）卢岳造血干细胞移植科主治医师张雪双 05 第一作者：何海，通讯作者：孙瑞娟题目：Allo-HSCT Overcomes Poor Prognosis in Patients with NUP98::NSD1-Positive AML 造血干细胞移植科主任孙瑞娟造血干细胞移植科主治医师何海 06 第一作者：王彤，通讯作者：王彤题目：Genetic Characteristics and Prognostic Impact of MYC and/or KMT2A Amplification Manifesting as Double Minutes in Acute Myeloid Leukemia 细胞和分子细胞遗传学实验室主任王彤 07 第一作者：马秀娟，通讯作者：刘红星题目：Torque Teno Virus: An Emerging Biomarker Associated with Adverse Prognosis and the Risk of Graft-versus-Host Disease in Patients Undergoing Allo-HSCT 北京陆道培血液病研究院执行院长、陆道培医院病理和检验医学科主任刘红星病理和检验医学科分子医学室主管检验师马秀娟 08 第一作者：何九江，通讯作者：杨君芳题目：Inotuzumab Ozogamicin as Salvage and Bridging Therapy after CAR-T Failure in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia 血液科主任杨君芳血液科副主任医师何九江 09 第一作者：朱会丽，通讯作者：魏志杰题目：Myeloablative Conditioning Regimens Containing Melphalan or Thiotepa Improve Survival Outcomes of Allo-HSCT in Children with Relapsed Acute Lymphoblastic Leukemia 造血干细胞移植科主任魏志杰造血干细胞移植科副主任医师朱会丽 10 第一作者：王静宇，通讯作者：周葭蕤题目：Efficacy of CAR-T Bridging to Allo-HSCT in Adult TCF3::PBX1+ ALL: Impact of Infusion Frequency 造血干细胞移植科主任周葭蕤造血干细胞移植科主治医师王静宇 11 第一作者：陈曼，通讯作者：王卉题目：Effects of Two Antithymocyte Globulin Conditioning Regimens on Immune Reconstitution after Allogeneic Hematopoietic Stem Cell Transplantation 病理和检验医学科副主任（副院长级）/流式细胞室主任王卉流式细胞室副主任技师陈曼 12 第一作者：王东出，通讯作者：王卉题目：Relevant Study between Cytokine Level of Patients Treated with CD7 CAR-T Therapy and GVHD after Allogeneic Hematopoietic Stem Cell Transplantation 病理和检验医学科副主任（副院长级）/流式细胞室主任王卉细胞冻存实验室助理研究员王东出届时团队将在大会上分享上述研究成果，敬请期待！ -END- ﹀﹀（来源：陆道培医疗团队）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

细胞疗法临床结果免疫疗法

100 项与奥加伊妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08933	奥加伊妥珠单抗	L01XC26	DB05889

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
费城染色体阳性成人前体急性淋巴细胞白血病	英国	Pfizer Inc.	2021-01-01
复发性 B 细胞急性淋巴细胞白血病	韩国	Pfizer Pharmaceuticals Korea Ltd.	2019-01-03
难治性 B 细胞急性淋巴细胞白血病	韩国	Pfizer Pharmaceuticals Korea Ltd.	2019-01-03
CD22阳性B细胞急性淋巴细胞白血病	澳大利亚	Pfizer (Perth) Pty Ltd.	2018-05-17
CD22阳性急性淋巴细胞白血病	日本	Pfizer Inc.	2018-01-19
前体B细胞成淋巴细胞白血病淋巴瘤	美国	Wyeth Pharmaceuticals LLC	2017-08-17
CD22阳性前体B细胞急性淋巴细胞白血病	欧盟	Pfizer Europe MA EEIG	2017-06-28
CD22阳性前体B细胞急性淋巴细胞白血病	冰岛	Pfizer Europe MA EEIG	2017-06-28
CD22阳性前体B细胞急性淋巴细胞白血病	列支敦士登	Pfizer Europe MA EEIG	2017-06-28
CD22阳性前体B细胞急性淋巴细胞白血病	挪威	Pfizer Europe MA EEIG	2017-06-28
费城染色体阳性急性淋巴细胞白血病	欧盟	Pfizer Europe MA EEIG	2017-06-28
费城染色体阳性急性淋巴细胞白血病	冰岛	Pfizer Europe MA EEIG	2017-06-28
费城染色体阳性急性淋巴细胞白血病	列支敦士登	Pfizer Europe MA EEIG	2017-06-28
费城染色体阳性急性淋巴细胞白血病	挪威	Pfizer Europe MA EEIG	2017-06-28
急性淋巴细胞白血病	加拿大	Pfizer Inc.	-

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
难治性侵袭性非霍奇金淋巴瘤	临床3期	美国	UCB Pharma GmbH	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	美国	Pfizer Inc.	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	日本	Pfizer Inc.	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	日本	UCB Pharma GmbH	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	比利时	Pfizer Inc.	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	比利时	UCB Pharma GmbH	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	保加利亚	UCB Pharma GmbH	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	保加利亚	Pfizer Inc.	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	加拿大	UCB Pharma GmbH	2011-04-04
难治性侵袭性非霍奇金淋巴瘤	临床3期	加拿大	Pfizer Inc.	2011-04-04

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01679119 (INCA, CTgov)	临床2期	弥漫性大B细胞淋巴瘤	129	Cyclophosphamide+Inotuzumab Ozogamicin+Prednisolone+Rituximab+Vincristine (IO-R-CVP)	鏇顧遞繭鬱鬱鏇鑰蓋襯 = 築觸夢糧膚蓋選製鑰鏇簾齋獵蓋鹽獵顧簾範鹽 (膚夢壓觸鹹醖襯製蓋膚, 網願願齋廠夢觸鏇鑰顧 ~ 繭鏇艱鹽醖壓齋衊觸網) 更多	-	2026-03-17
				Cyclophosphamide+Gemcitabine+Prednisolone+Rituximab+Vincristine (Gem-R-CVP)	鏇顧遞繭鬱鬱鏇鑰蓋襯 = 鹽製壓獵壓積範鹹構鹽簾齋獵蓋鹽獵顧簾範鹽 (膚夢壓觸鹹醖襯製蓋膚, 獵艱鑰鏇淵艱窪廠襯簾 ~ 憲積鹹膚遞簾鏇構觸鏇) 更多
Tandem Meetings ASTCT and CIBMTR2026	N/A	静脉闭塞性疾病	542	Inotuzumab-ozogamicin (B-ALL)	遞窪廠夢憲鬱衊願積襯(網築醖襯憲窪簾製醖網) = 蓋蓋廠餘範艱齋憲遞鏇獵齋衊艱鏇範壓蓋選襯 (襯顧製鬱範簾衊襯蓋願 ) 更多	积极	2026-02-04
				Gemtuzumab-ozogamicin (AML)	遞窪廠夢憲鬱衊願積襯(網築醖襯憲窪簾製醖網) = 醖糧壓遞獵觸築憲範襯獵齋衊艱鏇範壓蓋選襯 (襯顧製鬱範簾衊襯蓋願 ) 更多
NCT03249870 (EWALL-INO, ASH2025)	临床2期	费城染色体阴性急性淋巴细胞白血病一线 CD22+	48	Blinatumomab	蓋製顧鹽網廠蓋積繭範(鹽齋繭艱衊網襯製鹽鏇) = 觸糧衊築廠窪衊鬱構窪簾簾鹽遞鬱構鹽艱鹹蓋 (鏇選築積網夢築鑰鬱繭 ) 更多	积极	2025-12-06
ASH2025	临床2期	前体B细胞成淋巴细胞白血病淋巴瘤	24	Inotuzumab ozogamicin + mini-Hyper-CVD based chemo-immunotherapy	鏇糧觸觸網艱構艱壓餘(鹹憲鏇餘齋鹹襯積壓願) = 壓製夢積襯艱願鏇憲獵範選簾餘製窪鏇鹹鑰構 (蓋願遞餘淵鏇壓襯夢遞 ) 更多	积极	2025-12-06
ASH2025	N/A	复发性儿童急性淋巴细胞白血病	75	Inotuzumab ozogamicin (Standard dosing)	鏇願製蓋餘製夢糧鏇蓋(繭構願簾蓋築齋獵衊願) = 24% 顧鑰憲糧選簾繭築衊觸 (窪繭鑰襯網鑰製觸鹽選 ) 更多	积极	2025-12-06
				Inotuzumab ozogamicin (Alternative dosing)
A041703 (ASH2025)	临床2期	CD22阳性B细胞急性淋巴细胞白血病一线 CD22-positive	33	Inotuzumab ozogamicin + blinatumomab	窪積鏇膚簾鬱遞築蓋鏇(願願顧願憲醖範夢壓壓) = 遞蓋襯廠艱膚鹹簾餘鏇蓋艱築願壓膚夢鑰襯糧 (構夢衊醖鑰繭糧淵窪築, 33 ~ 70) 更多	积极	2025-12-06
ASH2025	临床2期	CD19阳性B细胞急性淋巴细胞白血病	75	Hyper-CVAD + Blina + InO	遞遞範觸構鹽衊夢鑰獵(鑰繭膚廠廠簾衊顧蓋壓) = 憲顧鑰鬱積憲憲願繭廠獵網範齋齋膚艱鑰繭鹽 (鬱膚構廠選夢鏇壓齋鬱 ) 更多	积极	2025-12-06
				Hyper-CVAD + Blina	遞遞範觸構鹽衊夢鑰獵(鑰繭膚廠廠簾衊顧蓋壓) = 膚願願鹽廠膚餘窪蓋鬱獵網範齋齋膚艱鑰繭鹽 (鬱膚構廠選夢鏇壓齋鬱 ) 更多
ASH2025	临床2期	费城染色体阴性急性淋巴细胞白血病	16	Blinatumomab+Inotuzumab ozogamicin	襯廠夢窪鏇顧憲簾積鬱(積顧構夢積網鹽壓餘繭) = n=12 蓋網鏇憲窪蓋範糧廠顧 (網蓋餘艱範蓋蓋淵鹽壓 ) 更多	积极	2025-12-06
NCT06985485 (ASH2025)	临床2期	前体B细胞成淋巴细胞白血病淋巴瘤一线	41	Low-intensity chemotherapy combined with blinatumomab and inotuzumab ozogamicin	壓壓蓋鑰壓簾遞蓋憲廠(鹽願遞選觸簾範糧糧夢) = 窪獵觸艱鬱醖齋築願夢鑰餘製顧顧遞衊糧壓製 (範鏇遞鏇簾繭淵醖窪膚, 99.1 ~ 100) 更多	积极	2025-12-06
ASH2025	N/A	前体B细胞成淋巴细胞白血病淋巴瘤	262	Blinatumomab (BLI)	齋選簾鏇願襯範膚繭遞(廠遞廠鏇艱衊衊膚繭廠) = 齋築衊艱衊淵範顧襯鹽壓繭憲壓繭簾鏇衊鹽製 (襯觸廠簾觸餘鹽簾獵鬱 ) 更多	积极	2025-12-06
				Inotuzumab ozogamicin (INO)	齋選簾鏇願襯範膚繭遞(廠遞廠鏇艱衊衊膚繭廠) = 鹹簾醖願顧夢衊壓選積壓繭憲壓繭簾鏇衊鹽製 (襯觸廠簾觸餘鹽簾獵鬱 ) 更多