A Phase II Study With a Safety Run-In of the Addition of N-803, a Novel IL-15 Super-Agonist, to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma

The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed).
Primary Aims
* To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed/refractory neuroblastoma is feasible and tolerable
* To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF
Secondary Aims
* To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF
* To evaluate and compare the progression free survival (PFS) and overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803

开始日期2025-11-10

申办/合作机构

St. Jude Children's Research Hospital, Inc.

NCT02130869

/ Completed临床1期IIT

A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas

This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Natural killer cells from a haploidentical family member will be given after high dose chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma, the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic cell recovery will be evaluated and survival of children treated with this approach will be determined.
The investigators expect to enroll 36 participants. Haploidentical family members (donors) will also be recruited to provide natural killer cells.

开始日期2014-10-10

申办/合作机构

St. Jude Children's Research Hospital, Inc.

NCT01857934

/ Active, not recruiting临床2期IIT

Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma

Neuroblastoma is the most common extracranial solid tumor in childhood, with nearly 50% of patients presenting with widespread metastatic disease. The current treatment for this group of high-risk patients includes intensive multi-agent chemotherapy (induction) followed by myeloablative therapy with stem-cell rescue (consolidation) and then treatment of minimal residual disease (MRD) with isotretinoin. Recently a new standard of care was established by enhancing the treatment of MRD with the addition of a monoclonal antibody (ch14.18) which targets a tumor-associated antigen, the disialoganglioside GD2, which is uniformly expressed by neuroblasts. Despite improvement in 2-year event-free survival (EFS) of 20%, more than one-third of children with high-risk neuroblastoma (HR defined in) still cannot be cured by this approach. Therefore, novel therapeutic approaches are needed for this subset of patients. This study will be a pilot Phase II study of a unique anti-disialoganglioside (anti-GD2) monoclonal antibody (mAb) called hu14.18K322A, given with induction chemotherapy.
PRIMARY OBJECTIVE:
* To study the efficacy [response: complete remission + partial remission (CR+PR)] to two initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4 doses/course followed by GM-CSF) in previously untreated children with high-risk neuroblastoma.
* To estimate the event-free survival of patients with newly diagnosed high-risk neuroblastoma treated with the addition of hu14.18K322A to treatment.
SECONDARY OBJECTIVES:
* To study the feasibility of delivering hu14.18K322A to 6 cycles induction chemotherapy and describe the antitumor activity (CR+PR) of this 6 course induction therapy.
* To estimate local control and pattern of failure associated with focal intensity modulated or proton beam radiation therapy dose delivery in high-risk abdominal neuroblastoma.
* To describe the tolerability of four doses of hu14.18K322A with allogeneic natural killer (NK) cells from an acceptable parent, in the immediate post-transplant period [day +2 - +5 after peripheral blood stem cell (PBSC) infusion] in consenting participants.
* To describe the tolerability of hu14.18K322A with interleukin-2 and GM-CSF as treatment for minimal residual disease (MRD).

开始日期2013-07-05

申办/合作机构

St. Jude Children's Research Hospital, Inc.

[+2]

100 项与 Hu14.18K322A 相关的临床结果

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100 项与 Hu14.18K322A 相关的转化医学

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100 项与 Hu14.18K322A 相关的专利（医药）

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项与 Hu14.18K322A 相关的文献（医药）

2026-01-21·BIOCONJUGATE CHEMISTRY

Utilization of Neutrophil Elastase Tetrapeptide Substrate as a Linker Agent for Anti-GD2 Antibody Drug Conjugates

Article

作者: Zhang, Junyi ; Zheng, Yanbo ; Gong, Jianhua ; Zheng, Yijia ; Gao, Lingli ; Yang, Jigang ; Zhang, Jiajia ; Wei, Hanrui

Disialoganglioside GD2 (GD2) is highly expressed in several tumors. While anti-GD2 antibodies and GD2-based antibody-drug conjugates (ADCs) have shown some therapeutic efficacy, their activity requires enhancement. Elastase, abundant in tumor microenvironment, has substrates that can serve as ADC linkers. Here, we constructed an anti-GD2 ADC by conjugating the anti-GD2 antibody Hu3F8 to the payload monomethyl auristatin E (MMAE) via an elastase-cleavable tetrapeptide linker (BMOA). Hu3F8 was produced using a 293F expression system, and its specific binding to GD2-positive cells was confirmed. The cytotoxicity of the ADCs was evaluated in both GD2-positive and GD2-negative tumor cell lines with or without elastase and its antitumor effects were investigated. It showed GD2-dependent cytotoxicity, with a significantly decreased IC₅₀ in GD2-positive cells upon elastase addition, while no cytotoxicity was observed in GD2-negative cells. Additionally, Hu3F8-BMOA-MMAE induced significant cell cycle arrest and apoptosis in GD2-positive cells, with stronger effects in the presence of elastase. In M21 melanoma mouse models, Hu3F8-BMOA-MMAE achieved an obvious tumor inhibition rate compared to the control. These findings demonstrate that utilizing a neutrophil elastase tetrapeptide substrate as a linker in anti-GD2 ADCs is a potential strategy for the therapy of GD2-positive tumors.

2025-08-20·BIOCONJUGATE CHEMISTRY

ImmunoPET Demonstrates that Co-Targeting GD2 and B7–H3 with Bispecific Antibodies Enhances Tumor Selectivity in Preclinical Melanoma Models

Article

作者: Erbe, Amy K. ; Medina-Guevara, Yadira ; Clemons, Nathan B. ; Hernandez, Reinier ; Sondel, Paul M. ; Engle, Jonathan W. ; Barnhart, Todd E. ; Jeffery, Justin J. ; Rosenkrans, Zachary T. ; Feils, Arika S.

Disialoganglioside 2 (GD2) is overexpressed in multiple cancers, such as melanoma and neuroblastoma, but also in peripheral nerves. To improve current GD2-targeting approaches, next-generation heterodimeric bispecific human IgG antibodies were created, each with one antibody binding fragment (Fab) arm specific for GD2 and the other Fab arm specific for B7-H3 (CD276) to drive tumor selectivity. The avidity and selectivity of our GD2-B7-H3 targeting bispecific antibodies (INV34-6, INV33-2, and INV36-6) were determined by flow cytometry and competition binding assays in GD2⁺/hB7-H3⁺ B78 cells. INV34-6 showed high avidity for GD2⁺/hB7-H3⁺ but not GD2⁺/hB7-H3^- B78 cells, contrasting with the similar cell binding to these cells observed with the anti-GD2 antibody Dinutuximab (DINU). The bispecific antibodies, DINU, and a nontargeted bispecific control (bsAb CTRL) were conjugated with deferoxamine for radiolabeling with Zr-89 (t_1/2 = 78.4 h). Positron emission tomography (PET) corroborated the in vivo avidity and selectivity of the GD2-B7-H3 targeting bispecific compared to bsAb CTRL and DINU in GD2⁺/hB7-H3⁺ and GD2⁺/hB7-H3^- B78 tumor models. PET in mice bearing the GD2⁺/hB7-H3^- and GD2⁺/hB7-H3⁺ B78 murine xenografts showed similar biodistribution in normal tissues for [⁸⁹Zr]Zr-Df-INV34-6, [⁸⁹Zr]Zr-Df-bsAb CTRL, and [⁸⁹Zr]Zr-Df-DINU. Importantly, [⁸⁹Zr]Zr-Df-INV34-6 tumor uptake was selective to GD2⁺/hB7-H3⁺ B78 over GD2⁺/hB7-H3^- B78 tumors, unlike [⁸⁹Zr]Zr-Df-DINU, which displayed elevated tumor uptake, irrespective of hB7-H3 expression. Nontargeted [⁸⁹Zr]Zr-Df-bsAb CTRL isotype control showed markedly lower uptake in all tested tumor models. Overall, bispecific antibodies binding GD2 and B7-H3 showed improved selectivity for targeting tumor cells expressing both antigens. This approach may enhance antitumor efficacy while addressing the toxicity limitations of current GD2-targeting therapies by reducing off-tumor GD2 binding in nerves.

2025-06-20·Theranostics

GD2-mediated impairment of macrophage phagocytosis drives pulmonary metastasis in osteosarcoma

Article

作者: Ge, Jun ; Song, Zhuorun ; Zhou, Quan ; He, Yunfei ; Wang, Chunjie ; Yang, Huilin ; Ding, Peng ; Zhang, Zeng ; Liu, Tao ; Yang, Peng ; Hou, Guanghui ; Lu, Shunyi ; Wu, Jichuan

Rationale: The lung is the most common site of metastasis in osteosarcoma, with pulmonary dissemination accounting for most of the disease-related mortality. Despite its clinical significance, the underlying mechanisms is poorly defined. Methods: To investigate the clinical relevance of GD2, we performed GD2 immunofluorescence staining on a cohort of human tumor samples. To explore the functional role of GD2 in lung metastasis, we employed an intravenous injection model and an intratibial injection model using U2OS and 143B cells respectively. To elucidate how GD2 regulates osteosarcoma lung metastasis, we carried out an in vitro flow-based phagocytosis assay. Results: We identify the disialoganglioside GD2 as a key mediator of osteosarcoma lung metastasis through impairing macrophage phagocytic function. Mechanistically, GD2 interacts with SIGLECE in mice (or SIGLEC7 in humans) on the cell surface of macrophages, leading to the activation of SH2-containing protein tyrosine phosphatase 2 (SHP2), which in turn suppresses macrophage phagocytic function. Notably, co-treatment with an anti-GD2 antibody and the SHP2 inhibitor SHP099 resulted in a synergistic reduction of lung metastasis. Conclusion: Our findings uncover a mechanism of osteosarcoma lung metastasis and highlight the GD2-SIGLEC-SHP2 axis as a promising therapeutic target.

项与 Hu14.18K322A 相关的新闻（医药）

2024-12-12

·GlobeNewswire-Health Care

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street Provides significant resources to build on diversified portfolio of established and rare disease medicines Egham, UK – 12 December 2024 – Essential Pharma (“Essential” or “the Company”), an international specialty pharma group focused on ensuring that patients have access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, today announces the completion of a €900 million financing, through a Gyrus Capital single-asset Continuation Vehicle led by AlpInvest, a subsidiary of Carlyle Global Investment Solutions, and a new strategic financing facility with Sixth Street. Essential Pharma was acquired in 2019 by Gyrus Capital, who have supported the transformation of the Company into a global, high-growth specialty pharma group with significant development opportunities. The transaction will enable Essential to deploy additional capital to build on its diversified portfolio and late-stage pipeline across established and rare disease medicines. This will be achieved through its successful acquisition and development strategy under the leadership of CEO, Emma Johnson. This additional capital will support Essential’s mission to ensure access to essential medicines for patients across new and existing markets. Since her appointment in 2023, Emma has driven the Company’s expansion into rare diseases, with the addition of marketed product Colobreathe® and Hu14.18, an immunotherapy in late-stage clinical development for the treatment of high-risk neuroblastoma. Following the transaction, Lee Morley, appointed as Non-Executive Director to the Board in 2023, will assume the role of Chairman of Essential Pharma, succeeding Dr Patrick Vink. Lee has more than 30 years’ experience in the biopharmaceutical industry, with extensive knowledge of commercialisation, pricing, reimbursement and product launch strategy. He was a co-founder and CEO at EUSA Pharma before the company’s €750 million acquisition by Recordati (BIT: REC) in 2022. During his time at EUSA Pharma, he led the company’s transition from specialty pharma to oncology and rare disease, driving sales from €20 million to €150 million. Emma Johnson, CEO of Essential Pharma, commented: “This transaction provides us with substantial additional firepower, strengthening our ability to deliver essential medicines to patients who need them most. By moving into new geographical markets and building on our diversified portfolio and late-stage pipeline across our key therapeutic areas, we can expand our reach to help underserved patient populations across the globe. We are excited to continue our relationship with Gyrus Capital as we execute our strategy to become a leading, global specialty pharma group with a growing rare disease presence, where patient needs are often most acute. As we transition to our new ownership, I’d also like to thank Patrick for his significant contributions as Chairman and welcome Lee as he steps into the role.” Dr Robert Watson, Managing Partner at Gyrus Capital, said: “This is a landmark investment for Essential and for Gyrus Capital. We are delighted to partner with AlpInvest, Stepstone, Sixth Street and other significant private capital institutions, who believe in our shared vision of building an exceptional specialty pharma company, and bringing critical medical products to patients across the globe.” Sixth Street, a leading global investment firm with deep experience supporting biotech companies across all stages of growth, is providing a new strategic financing facility consisting of €300 million in structured equity and growth debt. Jeff Pootoolal, Partner at Sixth Street who will join the board of Essential Pharma, said: “Essential Pharma has assembled a leading team and platform in its pursuit of providing patients around the world with critical medicines. We are excited to support Emma and Essential’s leadership as they continue to execute and expand on their mission.” About Essential Pharma Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche, branded medicines across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous supply to patients. For more information, please visit essentialpharmagroup.com About Gyrus Capital Gyrus Capital is a European investment firm dedicated to transformational investments in the healthcare and sustainability sectors. Based in Geneva, Switzerland, Gyrus invests in businesses that address the structural needs of society and the environment and are positioned for long-term sustainable growth. The firm focuses on complex transactions, particularly corporate carve-outs in the €50 million to €500 million range. A renowned group of experienced partners and industry experts supports Gyrus’s active investment and value-creation approach, working closely with entrepreneurs and managers. To learn more, please visit www.gyruscapital.com About Sixth Street Sixth Street is a global investment firm with over $80 billion in assets under management and committed capital. Sixth Street uses its long-term flexible capital, data-enabled capabilities, and One Team culture to develop themes and offer solutions to companies across all stages of growth. Sixth Street Healthcare and Life Sciences finances the development and commercialization of innovative therapeutics and invests in healthcare technology companies across all stages of growth. Investments in the sector include Apellis Pharmaceuticals, Arrowhead Pharmaceuticals, Arsenal Biosciences, Biohaven, Blueprint Medicines, Caris Life Sciences, Chroma Medicine, ConcertAI, Datavant, Immunogen, Ironwood, and Mammoth Biosciences, among many others. Founded in 2009, Sixth Street has more than 650 team members including over 250 investment professionals operating around the world. For more information, visit www.sixthstreet.com, or follow Sixth Street on LinkedIn. CONTACTS Essential Pharma Emma Johnson, CEO Tel: +44(0)1784 477 167 Email: info@essentialpharmaceuticals.com ICR Healthcare Tracy Cheung/Sukaina Virji/Isabelle Abdou Tel: +44 (0) 20 3709 5700 Email: Essentialpharma@icrhealthcare.com

高管变更并购

2024-06-12

·GlobeNewswire-Health Care

Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma

Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma 11 June, 2024 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, today announced its rare disease business has signed a strategic agreement with AGC Biologics. As a leading global biopharmaceutical contract development and manufacturing organisation (CDMO), AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB). Under the agreement, AGC Biologics will support the process development, scale-up and manufacturing as Essential Pharma plans to commence clinical activities and ongoing regulatory agency interactions over the coming months. Simon Ball, Vice President of the rare disease business at Essential Pharma, commented: "This partnership is a tremendous milestone in the development of Hu14.18 and its path to commercialization. The prospect of building an inventory of Hu14.18 is very exciting. Ahead of us is a period of intense regulatory agency interaction, which will take place alongside late-stage clinical development, and we are a step closer to providing this high-potential antibody to a patient group that is desperately in need of more optimal treatments and better outcomes.” "AGC Biologics is a global leader in contract antibody development and manufacturing,” stated Emma Johnson, CEO of Essential Pharma. “This partnership will help us to accelerate the late-stage development of Hu14.18, which shows therapeutic promise for high-risk neuroblastoma patients, the majority of whom are young children. We look forward to working closely with AGC to deliver this potentially transformative therapy in an area of significant unmet need.” Christoph Winterhalter, CBO at AGC Biologics, said: “We are very pleased that Essential Pharma has chosen us to manufacture this innovative therapy. Our Copenhagen site has the expertise and experience in therapeutic antibodies to accelerate the late-stage development and manufacturing of Hu14.18. We look forward to partnering with Essential Pharma and working together to ensure the product meets the high level of quality, yield and all data packages needed to successfully master future clinical trials and regulatory agency submissions to supply patients across the globe with this life-saving product.” Essential Pharma acquired Renaissance Pharma in April 2024 and is now responsible for the development of Hu14.18. A Phase II trial incorporating Hu14.18 into first-line therapy, and additionally within post-consolidation therapy for HRNB patients, demonstrated positive patient outcomes with 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%. Data from this study were published in the Journal of Clinical Oncology in December 2021 and are approaching five-year OS readouts.1 Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous and sustainable supply to patients. Essential Pharma is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long-term sustainable growth, including healthcare. 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, every step of the way. We provide world-class development and manufacture 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 cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs ten different facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. 1 Furman WL, McCarville B, Shulkin BL, Davidoff A, Krasin M, Hsu CW, et al. Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. Journal of Clinical Oncology [Internet]. 2022 Feb 1;40(4):335–44. Available from: http://dx.doi.org/10.1200/jco.21.01375 The content above comes from the network. if any infringement, please contact us to modify.

临床结果免疫疗法

2024-04-18

·Pharmaceutical Technology

Essential Pharma acquires Reminyl from Janssen Pharmaceutica

Reminyl is intended to treat mild to moderately severe dementia of the Alzheimer type. Credit: Hryshchyshen Serhii / Shutterstock.com. Speciality pharmaceutical group Essential Pharma has concluded the acquisition of Reminyl oral capsules from Johnson & Johnson company Janssen Pharmaceutica. The strategic move enhances Essential Pharma’s portfolio of central nervous system (CNS) medicines and expands its global footprint, particularly in Asia-Pacific. A cholinesterase inhibitor, Reminyl is an established CNS drug for mild to moderately severe dementia of the Alzheimer type. Essential Pharma will now hold rights to Reminyl in the European Economic Area, South Korea, Thailand and all other existing markets for this product. The deal excludes the UK and Ireland, Japan and Latin America. See Also: Inaticabtagene autoleucel by Juventas Cell Therapy for Acquired (Autoimmune) Hemolytic Anemia: Likelihood of Approval Ulixacaltamide hydrochloride by Praxis Precision Medicines for Essential Tremor: Likelihood of Approval The acquisition aligns with Essential Pharma’s focus on CNS, gastroenterology, ophthalmology and rare diseases. Essential operates in more than 70 countries and is supported by healthcare investment firm Gyrus Capital. Essential CEO Emma Johnson stated: “Our acquisition of rights to Reminyl in these markets will ensure Alzheimer’s patients and caregivers in those regions have continued access to this vital medicine. “The acquisition represents a significant and synergistic addition to our concentrated portfolio of CNS products, further expanding our global presence and solidifying our position as a leading speciality pharma group.” The latest development comes after Essential Pharma acquired clinical-stage pharmaceutical company Renaissance Pharma for an undisclosed sum in April 2024. Renaissance develops treatments for paediatric rare diseases, with its lead asset, Hu14.18K322A, currently being analysed in a Phase II clinical trial to treat high-risk neuroblastoma.

临床2期细胞疗法并购临床1期

100 项与 Hu14.18K322A 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
高风险神经母细胞瘤	临床2期	美国	St. Jude Children's Research Hospital, Inc.	2013-07-05
淋巴瘤	临床1期	美国	St. Jude Children's Research Hospital, Inc.	2014-10-10
尤文肉瘤	临床1期	美国	St. Jude Children's Research Hospital, Inc.	2008-10-08
黑色素瘤	临床1期	美国	St. Jude Children's Research Hospital, Inc.	2008-10-08
难治性神经母细胞瘤	临床1期	美国	St. Jude Children's Research Hospital, Inc.	2008-10-08
难治性骨肉瘤	临床1期	美国	St. Jude Children's Research Hospital, Inc.	2008-10-08

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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


NCT01857934 (CTgov)	临床2期	神经母细胞瘤 \| 高风险神经母细胞瘤	153	hu14.18K322A (NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A))	艱構願築願範鹽鏇淵築 = 積遞糧顧襯膚窪鏇鏇衊網鑰憲蓋願繭艱獵鹽蓋 (鑰製範鬱憲膚艱鏇築繭, 膚觸廠範鑰鹽齋窪壓廠 ~ 夢簾餘衊鹽積鑰衊顧積)	-	2023-02-24
NCT01857934 (CTgov)	临床2期	神经母细胞瘤 \| 高风险神经母细胞瘤	153	NB2012+hu14.18K322A (NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A))	觸遞廠齋糧壓艱艱糧選 = 鑰選簾鬱顧範獵艱夢願蓋餘齋鑰鹹艱鹹鑰鬱廠 (膚艱範蓋衊艱夢艱鬱衊, 鬱糧餘觸鑰壓獵窪醖鹽 ~ 範鹽繭鑰襯蓋膚鏇膚糧) 更多	-	2023-02-24
NCT01857934 (Pubmed \| J Clin Oncol)	临床2期	高风险神经母细胞瘤	-	hu14.18K322A	鏇衊膚網築艱製網艱齋(觸醖壓積選窪壓願顧觸) = 艱鑰衊淵衊顧鏇衊憲衊獵觸範選願鹹範衊淵衊 (鑰鏇鹹鑰網鹹顧積繭醖, 60.0 ~ 83.4) 更多	积极	2022-02-01
NCT01857934 (Pubmed \| Clin Cancer Res) 人工标引	临床2期	神经母细胞瘤一线	42	Chemotherapy+hu14.18K322A	顧顧鏇獵蓋範遞獵糧廠(願願醖構積壓積壓壓構) = 憲蓋獵淵憲築襯衊膚鬱遞憲鑰醖鏇餘衊觸遞蓋 (壓襯鹹壓夢壓艱糧廠壓, 70.9 ~ 93.3) 更多	积极	2019-11-01
NCT01576692 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	复发性神经母细胞瘤 \| 难治性神经母细胞瘤	13	Chemotherapy+hu14.18K322A+NK cells	蓋願繭鑰膚鏇窪餘遞範(襯觸築觸網鹽鑰鏇選遞) = One patient developed an unacceptable toxicity (grade 4 thrombocytopenia >35 days). Four patients discontinued treatment for adverse events (hu14.18K322A allergic reaction, viral infection, surgical death, second malignancy). Common toxicities included grade 3/4 myelosuppression (13/13 patients) and grade 1/2 pain (13/13 patients). 鏇醖鹹築醖鏇繭積襯遞 (製餘繭醖餘蓋膚繭鹹壓 )	积极	2017-11-01
NCT00743496 (Pubmed \| J Clin Oncol)	临床1期	神经母细胞瘤 GD2	-	Hu14.18K322A	鏇衊壓窪蓋鑰觸衊繭醖(夢顧鏇願製糧範鑰窪夢) = 夢範鑰餘簾憲鏇糧顧觸簾齋衊窪網膚廠觸膚餘 (鏇鹽壓觸獵廠簾鏇構艱 )	-	2014-05-10