诺格白介素α-因奇西普(Nogapendekin alfa inbakicept-pmln) - 药物靶点：IL-15 x IL-2Rβγ_在研适应症：淋巴细胞减少，非肌层浸润性膀胱肿瘤，转移性非小细胞肺癌_专利_临床

概要

基本信息

药物类型

Fc融合蛋白

别名

IL-15N72D:IL-15RαSu/Fc fusion protein complex、Inbakicept、Nogapendekin alfa inbakicept

+ [6]

靶点

IL-15 x IL-2Rβγ

作用方式

激动剂、刺激剂

作用机制

IL-15激动剂(白细胞介素-15激动剂)、IL-2Rβγ激动剂(白细胞介素-2受体βγ亚基复合物激动剂)、免疫刺激剂

治疗领域

肿瘤泌尿生殖系统疾病呼吸系统疾病+ [9]

在研适应症

淋巴细胞减少非肌层浸润性膀胱肿瘤转移性非小细胞肺癌+ [24]

非在研适应症

急性早幼粒细胞白血病晚期恶性实体瘤晚期三阴性乳腺癌+ [18]

原研机构

Altor BioScience Corp.

在研机构

ImmunityBio, Inc.

Altor BioScience Corp.Serum Life Science Europe GmbH

+ [1]

非在研机构-

权益机构

Altor BioScience Corp.

深圳市北科生物科技有限公司

最高研发阶段批准上市

首次获批日期

美国 (2024-04-22),

非肌层浸润性膀胱肿瘤

最高研发阶段(中国)临床2期

特殊审评突破性疗法 (美国)、快速通道 (美国)

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结构/序列

Sequence Code 14770950

关联

84

项与诺格白介素α-因奇西普相关的临床试验

NCT07085338

/ Not yet recruiting临床2期IIT

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2025-12-01

申办/合作机构

St. Jude Children's Research Hospital, Inc.

NCT05642195

/ Suspended临床1/2期IIT

Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

Background:
Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back.
Objective:
To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC.
Eligibility:
Adults aged 18 years or older with no sign of disease after surgery for NSCLC.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans.
Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit:
The study vaccine is given as 2-4 small shots under the skin of the thigh or arm.
N-803 is given as a shot under the skin of the abdomen.
Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study.
Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment.
Follow-up visits will continue for up to 5 years.

开始日期2025-09-23

申办/合作机构

National Cancer Institute

NCT06161545

/ Recruiting临床2期IIT

A Phase II Sequential Window of Opportunity Trial of Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma

Background:
Squamous cell carcinoma is a type of cancer that can cause tumors on the head and neck (HNSCC). Even with treatment, less than 50% of people with certain types of HNSCC survive for 5 years.
Objective:
To test a new drug treatment (N-803 and pembrolizumab, with or without PD-L1 t-haNK cells) in people with HNSCC. These drugs may help the immune system to fight cancer.
Eligibility:
People aged 18 years and older who have HNSCC that is not linked to human papillomavirus infection. They must not yet have received any treatment and be scheduled for surgery to remove the tumors.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They will have a biopsy: A sample of tissue will be removed from the tumor.
Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm (intravenous infusion). N-803 is injected under the skin of the abdomen. All participants will receive these 2 treatments on day 1. They will have follow-up visits on days 8 and 15.
Some participants will also receive PD-L1 t-haNK cells by intravenous infusion. These are cells that attack cancer cells. These participants will receive this treatment on days 1, 5, 8, 12, and 15.
All participants will have a clinic visit on day 21. They will have a second biopsy.
Follow-up visits will occur on days 49 and 105. Visits will continue by phone or email every 9 weeks for 2 years....

开始日期2025-09-23

申办/合作机构

National Cancer Institute

100 项与诺格白介素α-因奇西普相关的临床结果

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100 项与诺格白介素α-因奇西普相关的转化医学

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100 项与诺格白介素α-因奇西普相关的专利（医药）

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105

项与诺格白介素α-因奇西普相关的文献（医药）

2025-08-19·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Therapeutic CD8⁺ T cell tissue retention and immunomodulation during ART interruption fail to prevent SIV rebound.

Article

作者: Viox, Elise G ; Samer, Sadia ; Deleage, Claire ; Kuri-Cervantes, Leticia ; Betts, Michael R ; Paiardini, Mirko ; Safrit, Jeffrey T ; Pampena, M Betina ; Davenport, Miles P ; Regan, James ; Docken, Steffen ; Bar, Katharine J ; Wu, Vincent H ; Keele, Brandon F ; Nguyen, Kevin

A primary obstacle for HIV elimination is the long-term viral reservoir in lymphoid tissues (LT) that can cause rebound viremia if therapy is stopped. Cytotoxic CD8⁺ T cells are critical for control of HIV and Simian immunodeficiency virus (SIV) viremia; however, CD8⁺ T cells that migrate to LT are primarily noncytotoxic, calling into question whether these cells could reduce the viral reservoir on antiretroviral therapy (ART) or control viral replication when therapy is halted. To determine whether CD8⁺ T cells can inhibit viral replication when retained in LT, we inhibited lymphocyte egress from LTs in ART-treated SIV-infected rhesus macaques (RMs) during analytic treatment interruption (ATI) using the S1PR modulator FTY720 alone or in combination with anti-PD1 antibody (αPD1) and the IL-15 receptor superagonist N-803 to increase cytolytic function. FTY720 retained migrating CD4⁺ and CD8⁺ T cells in LT, whereas cytotoxic CD8⁺ T cells remained in the vasculature. After ATI and viral rebound, activated SIV-specific CD8⁺ T cells increased in frequency in LT of FTY720-treated RMs but failed to become cytotoxic or control plasma viremia compared to controls, even when combined with αPD1 and N-803. These findings indicate that LT-localized CD8⁺ T cells alone may be insufficient to delay or prevent plasma viral rebound during ATI.

2025-07-08·JCI Insight

Impact of the IL-15 superagonist N-803 on lymphatic reservoirs of HIV

Article

作者: Wieking, Garritt ; Miller, Jeffrey S ; Beilman, Gregory J ; Schacker, Timothy W ; Reichel, Jarrett ; Safrit, Jeffrey T ; Baker, Jason V ; Deeks, Steven G ; Khoruts, Alexander ; Klatt, Nichole R ; Vaughn, Byron P ; Soon-Shiong, Patrick ; Anderson, Jodi ; Chipman, Jeffrey G ; Cromarty, Ross ; Batres, Rodolfo ; Davis, Zachary B ; Eilkhani, Elnaz ; Escandón, Kevin ; Eaton, Anne ; Hinderlie, Peter ; Basting, Christopher M ; Rhein, Joshua

BACKGROUNDNK cell function is impaired in people with HIV (PWH), hindering their potential to reduce the lymphoid tissue (LT) reservoir. The IL-15 superagonist N-803 has been shown to enhance NK and T cell function and thus may reduce viral reservoirs.METHODSTo determine the impact of N-803 on LTs, we conducted a clinical trial where 10 PWH on effective antiretroviral therapy (ART) were given 3 subcutaneous 6 mcg/kg doses of N-803. We obtained PBMCs and lymph node (LN) and gut biopsies at baseline and after the last N-803 dose.RESULTSWe found a nonstatistically significant approximately 0.50 median log reduction in the frequency of viral RNA+ (vRNA+) and vDNA+ cells/g in the 6 participants with baseline and posttreatment LN biopsies. In the ileum, we observed reductions of vRNA+ cells in 8/10 participants and vDNA+ cells in all participants. We also found significant inverse correlations between NK cell proliferation and the frequency of vRNA+ cells and between NKG2A expression on NK cells and the frequency of vRNA+ cells.CONCLUSIONOur findings suggest N-803 may reduce the HIV reservoir in LTs of PWH on ART, an effect likely mediated by enhanced NK cell function. Controlled studies assessing the impact of NK cell therapy on HIV LTs are needed.TRIAL REGISTRATIONClinicalTrials.gov NCT04808908.FUNDINGNIH grants 5UM1AI126611, UL1TR002494, R01 AI147912, R35 CA283892, and UM1AI164561.

2025-05-01·Journal for ImmunoTherapy of Cancer

Combination of a therapeutic cancer vaccine targeting the endogenous retroviral envelope protein ERVMER34-1 with immune-oncology agents facilitates expansion of neoepitope-specific T cells and promotes tumor control

Article

作者: Donahue, Renee N ; Maldonado, Maria Del Mar ; Palena, Claudia ; Schlom, Jeffrey ; Iida, Masafumi ; Hamilton, Duane H ; Gulley, James L ; Gracia-Hernandez, Maria ; Le, Loc Huu

Background:

Endogenous retroviruses (ERVs) are remnants of retrovirus germline infections that occurred over the course of evolution and constitute between 5% and 8% of the human genome. While ERVs tend to be epigenetically silenced in normal adult human tissues, they are often overexpressed in carcinomas and may represent novel immunotherapeutic targets. This study characterizes the ERV envelope protein ERVMER34-1 as a target for a therapeutic cancer vaccine.

Methods:

The expression of ERVMER34-1 in multiple healthy adult and cancer tissues was assessed, as was its immunogenicity, to ascertain whether specific T cells could lyse human carcinoma cell lines expressing ERVMER34-1. Furthermore, the ability of a rationally designed ERVMER34-1-targeted therapeutic vaccine to induce tumor clearance in two murine carcinoma models expressing ERVMER34-1 was examined either as a monotherapy or in combination with anti-programmed cell death protein-1/programmed death-ligand 1 monoclonal antibody (mAb) or the interleukin-15 superagonist N-803.

Results:

The ERVMER34-1 protein was shown to be overexpressed in 232/376 of human carcinomas analyzed while being absent in most healthy adult tissues. High levels of ERVMER34-1 RNA expression associate with decreased survival in uveal melanoma, adenoid cystic, and head and neck carcinomas. ERVMER34-1-specific T cells were detected in peripheral blood mononuclear cells (PBMCs) of patients with cancer but not healthy donors following an overnight stimulation. However, reactive T cells are readily expanded from both healthy donor and patient with cancer PBMCs following a 7- day in vitro stimulation. Furthermore, ERVMER34-1-specific T cells selectively kill human carcinoma cell lines expressing ERVMER34-1. A novel, rationally designed, therapeutic cancer vaccine targeting ERVMER34-1 mediated tumor control in established syngeneic murine tumors expressing the full-length ERVMER34-1 protein. When combined with checkpoint blockade, the vaccine promoted expansion of neoepitope-reactive T cells whose function was further enhanced when combined with N-803. This expansion of neoepitope-reactive T cells was associated with tumor control.

Conclusions:

This study reveals the potential of a vaccine that targets the retroviral envelope protein ERVMER34-1 and supports its continued development toward clinical testing as a new class of therapeutic cancer vaccine.

236

项与诺格白介素α-因奇西普相关的新闻（医药）

2025-09-18

·香港证券交易所

海外監管公告 - 關於藥物納入擬突破性治療品種公示名單的公告

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司（於中華人民共和國註冊成立的股份有限公司）（股份代號：1276）海外監管公告本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。承董事會命江蘇恒瑞醫藥股份有限公司董事長孫飄揚先生中國上海 2025年9月18日於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。证券简称：恒瑞医药证券代码：600276 江苏恒瑞医药股份有限公司关于药物纳入拟突破性治疗品种公示名单的公告本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。近日,江苏恒瑞医药股份有限公司（以下简称“公司”）子公司上海恒瑞医药有限公司的注射用SHR-1501被国家药品监督管理局药品审评中心（以下简称“药审中心”）纳入拟突破性治疗品种公示名单，公示期7日。现将相关情况公告如下：一、药物的基本情况药物名称：注射用SHR-1501 受理号：CXSL2101496 药物类型：治疗用生物制品注册分类：1类申请日期：2025年7月23日拟定适应症（或功能主治）：注射用SHR-1501联合卡介苗（BCG）用于BCG无应答的非肌层浸润性原位癌（CIS）患者。理由及依据：经审核，本申请符合《药品注册管理办法》和《国家药监局关于发布＜突破性治疗药物审评工作程序（试行）＞等三个文件的公告》（2020年第82号）有关要求，同意纳入突破性治疗药物程序。二、药物的其他相关情况 SHR-1501为公司自主研发并具有知识产权的白细胞介素-15（IL-15）融合蛋白，可以刺激体内T细胞、B细胞和NK细胞增殖，发挥调动机体免疫系统清除体内异物（如肿瘤）的作用，其与BCG联用可明显增强膀胱内的免疫反应，达到协同抗肿瘤的效果。与IL-2相比，IL-15不会刺激调节性T细胞增殖和诱导T细胞凋亡。目前国外同类产品Nogapendekin Alfa Inbakicept（商品名：Anktiva）已于美国获批上市销售，国内未有相同靶点产品获批上市。截至目前，注射用SHR-1501相关项目累计研发投入约10,218万元。三、风险提示根据《国家药监局关于发布＜突破性治疗药物审评工作程序（试行）＞等三个文件的公告》（2020年第82号），药审中心对纳入突破性治疗药物程序的药物优先配置资源进行沟通交流，加强指导并促进药物研发。药品研发容易受到技术、审批、政策等多方面因素的影响，审评政策及未来药品市场竞争形势等存在诸多不确定性风险，上述产品存在突破性治疗药物程序公示期被提出异议的风险。敬请广大投资者谨慎决策，注意防范投资风险。公司将按国家有关规定积极推进上述研发项目，并及时对项目后续进展情况履行信息披露义务。特此公告。江苏恒瑞医药股份有限公司董事会

突破性疗法ASH会议申请上市

2025-09-10

·FiercePharma

J&J's 'practice-changing' bladder cancer therapy Inlexzo lands FDA nod

With an 82% complete response rate seen in trials, Johnson & Johnson has touted high market hopes for the med. The FDA has signed off on Johnson & Johnson’s highly anticipated bladder cancer drug Inlexzo, marking an advance in the ability to care for patients who otherwise face bladder removal and limited treatment options.Inlexzo, previously called TAR-200, can now treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.The drug-releasing system combo allows for extended release of the chemotherapy gemcitabine directly to patients' bladders through an intravesical system that can be placed in minutes in an outpatient setting, with no general anesthesia needed, J&J said in a Sept. 9 release.Before the approval, the typical treatment route for NMIBC patients who don’t respond to standard-of-care BCG therapy was a radical cystectomy to remove the entire bladder. It's a life-altering and risky procedure that's not appropriate for many patients. J&J’s offering, meanwhile, provides a “potentially practice-changing” treatment, the company said.“We are proud of the science that has brought us to this historic moment,” John Reed, M.D., Ph.D., head of R&D at J&J Innovative Medicine, said in a statement. “As the only major healthcare company that hosts both pharmaceuticals and medical devices, we leveraged the speed and scale of Johnson & Johnson to accelerate innovation and deliver this important therapy to patients.”J&J picked up the asset from Taris Biomedical in 2019 with hopes to “give patients with bladder cancer a renewed sense of hope and belief,” Jennifer Taubert, J&J's head of Innovative Medicine, commented. “In an area that has seen little progress for more than 40 years, Inlexzo delivers a first-of-its-kind breakthrough innovation with a bright future ahead.” In a phase 2b study, 82% of Inlexzo-treated patients experienced a complete response without the need for reinduction, with 51% maintaining the response for at least one year. The complete response rate is the highest recorded among currently available therapies, Mark Wildgust, Ph.D., vice president of oncology global medical affairs for J&J Innovative Medicine, said in an interview with Fierce Pharma earlier this year.With its high complete response rate and its convenience factor, J&J believes Inlexzo will set itself apart from other bladder cancer offerings such as Merck’s Keytruda, Ferring Pharmaceuticals’ gene therapy Adstiladrin and ImmunityBio’s immunotherapy Anktiva, which is used alongside the BCG vaccine. The company has high hopes for the drug’s market potential.“In all the research that we have done, I have absolutely no reason to believe that they will use anything else but us once they fail BCG,” the president of J&J’s solid tumor business, Biljana Naumovic, told Fierce Pharma in April. She acknowledged, however, that the drug won’t reach that level of market dominance right away. J&J has already set up a patient support program and a Care Navigator offering educational resources at no cost to patients. Inlexzo is being further studied across patients with MIBC and those with NMIBC in four ongoing clinical trials.

临床结果临床2期免疫疗法疫苗上市批准

2025-08-28

·药明康德

100%疾病控制率！潜在重磅疗法组合积极试验结果公布；诺和诺德达成5.5亿美元RNA疗法合作

100%疾病控制率！潜在重磅疗法组合积极试验结果公布 ImmunityBio近日公布一项探索性研究的最新结果。该研究评估其免疫增强方案用于治疗5例复发性胶质母细胞瘤（GBM）患者的疗效与安全性。该方案包含IL-15激动剂Anktiva（nogapendekin alfa inbakicept，旨在增强自然杀伤细胞活性）、NK细胞疗法（PD-L1 t-haNK）以及Optune Gio肿瘤电场治疗装置。分析显示，在接受治疗的5名患者中，3名患者获得缓解，其中2名接近完全缓解，另2名至今维持疾病稳定，患者的整体疾病控制率（DCR）达100%。新闻稿指出，对于复发性GBM二线患者而言，这一无需化疗方案的积极试验结果极具意义。基于这一初步发现，ImmunityBio计划启动一项随机对照临床试验，专门针对在标准治疗后仍出现疾病复发的二线GBM患者。 Anktiva是一款IL-15超级激动剂。该疗法在2019年获FDA授予突破性疗法认定，用于与卡介苗（BCG）联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。2024年4月，美国FDA批准Anktiva与BCG联合使用，用于治疗对BCG无应答且伴有原位癌的非肌层浸润性膀胱癌成年患者，这些患者伴或不伴有乳头状肿瘤。值得一提的是，行业媒体Evaluate曾将这款疗法列为2024年有望获批的10款潜在重磅疗法之一。诺和诺德达成5.5亿美元RNA疗法合作 Replicate Bioscience今日宣布与诺和诺德（Novo Nordisk）达成一项为期多年的研究合作。此次合作将结合诺和诺德在治疗和药物开发方面的深厚经验，以及Replicate创新的自我复制RNA（srRNA）平台，共同开发用于治疗肥胖、2型糖尿病及其他心脏代谢疾病的新型候选疗法。根据协议，双方将在特定心脏代谢疾病靶点上展开合作，诺和诺德将获得Replicate srRNA平台的全球独家许可，用于开发和商业化相关项目。Replicate将获得研究经费，并有资格从诺和诺德处获得高达5.5亿美元的资金支持，包括预付款和潜在里程碑付款等款项。 Replicate拥有完善的srRNA专有技术，可根据需求定制蛋白表达特征。相比其他RNA技术，其平台在体内表现出更高水平的蛋白表达、更持久的效果以及更灵活的调控能力。Replicate正通过其创新的srRNA技术克服传统RNA疗法的不足，在生物活性、免疫反应强度及治疗指数方面展现出提升潜力。目前，公司研发的临床阶段狂犬病疫苗RBI-4000已在1期试验中显示出在低于其他RNA疫苗剂量下实现保护性免疫水平的成果。参考资料： [1] Replicate Bioscience Announces Partnership with Novo Nordisk to Unlock Self-Replicating RNA Therapies for Obesity and Diabetes. Retrieved August 28, 2025 from https://www.prnewswire.com/news-releases/replicate-bioscience-announces-partnership-with-novo-nordisk-to-unlock-self-replicating-rna-therapies-for-obesity-and-diabetes-302540245.html [2] Initial Data Shows 100% Disease Control in 5 Out of 5 Patients With Recurrent Glioblastoma With Two Patients in Near Complete Response Treated With ImmunityBio’s ANKTIVA®, NK Cell Therapy Plus Optune Gio® Device. Retrieved August 28, 2025 from https://www.businesswire.com/news/home/20250826147574/en/Initial-Data-Shows-100-Disease-Control-in-5-Out-of-5-Patients-With-Recurrent-Glioblastoma-With-Two-Patients-in-Near-Complete-Response-Treated-With-ImmunityBios-ANKTIVA-NK-Cell-Therapy-Plus-Optune-Gio-Device 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床1期突破性疗法临床2期临床结果

100 项与诺格白介素α-因奇西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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
淋巴细胞减少	美国	ImmunityBio, Inc.	2025-06-02
非肌层浸润性膀胱肿瘤	美国	Altor BioScience Corp.	2024-04-22

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
转移性非小细胞肺癌	临床3期	美国	ImmunityBio, Inc.	2018-05-18
膀胱癌	临床3期	美国	ImmunityBio, Inc.	2017-06-02
新冠肺炎后遗症	临床2期	美国	ImmunityBio, Inc.	2025-08-01
前列腺腺癌	临床2期	-	ImmunityBio, Inc.	2025-05-15
铂耐药性卵巢癌	临床2期	美国	ImmunityBio, Inc.	2024-11-06
复发性铂耐药性卵巢癌	临床2期	美国	ImmunityBio, Inc.	2024-11-06
多形性胶质母细胞瘤	临床2期	美国	ImmunityBio, Inc.	2024-08-07
胶质母细胞瘤，IDH野生型	临床2期	美国	ImmunityBio, Inc.	2024-08-07
头颈癌转移	临床2期	美国	ImmunityBio, Inc.	2024-02-16
复发性头颈癌	临床2期	美国	ImmunityBio, Inc.	2024-02-16

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NEWS 人工标引	N/A	复发性胶质母细胞瘤	5	Anktiva	鹽餘夢壓夢齋衊積範窪(艱網範顧膚網選鑰網廠) = 糧窪製餘範衊淵獵獵淵遞鏇鹽網築簾獵夢鹽膚 (淵齋廠願構簾蓋範築膚 )	积极	2025-08-29
NCT04390399 (QUILT-88, ASCO2025)	临床2期	转移性胰腺癌 ALC \| CA19-9	84	N-803 and PD-L1 t-haNK chemo-immunotherapy	廠積構構廠膚鏇糧鏇壓(觸築獵鹽窪網積築鹹鹽) = Grade 3 or higher TEAEs occurred in 95% of patients and were largely chemotherapy-associated 鹹製鏇遞願簾顧積鑰觸 (網糧醖廠製鑰構觸糧鹽 )	积极	2025-05-30
				Low-dose SBRT and low-dose chemotherapy
NCT03022825 (QUILT-3.032, Company_Website \| Literature) 人工标引	临床2/3期	非肌层浸润性膀胱肿瘤	180	ANKTIVA®ANKTIVA® plus BCG (CIS with or without Papillary)	鑰鏇範製顧鑰繭齋糧積(餘願壓壓衊醖艱獵築觸) = 淵鏇鏇積鹹鹽壓繭淵蓋構淵鹹鹽鹽鏇鑰鹹鬱遞 (憲顧遞鏇衊膚壓醖鏇齋 ) 更多	积极	2025-04-28
				ANKTIVA® Plus BCG (Papillary without CIS)	鑰鬱蓋遞製願憲願獵鹹(網網獵窪鏇壓襯醖淵窪) = 鹽簾積範築遞襯積壓簾窪淵製醖夢獵範繭艱鬱 (鹽網壓鹽膚膚鹹觸鏇鹽 ) 更多
NCT03381586 (CTgov)	临床1期	-	20	ALT-803 (Group A)	鏇夢獵壓鑰選遞餘築鹽(願窪顧願憲積糧蓋簾蓋) = 繭網壓鏇遞鏇廠鏇遞夢選齋簾糧觸憲簾網簾夢 (壓憲淵顧築衊鹽餘廠鹹, 0.813) 更多	-	2025-03-24
				ALT-803 (Group B)	鏇夢獵壓鑰選遞餘築鹽(願窪顧願憲積糧蓋簾蓋) = 鬱夢衊簾鏇鏇蓋廠網廠選齋簾糧觸憲簾網簾夢 (壓憲淵顧築衊鹽餘廠鹹, 0.095) 更多
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+ETBX-011+5-fluorouracil+ALT-803+ETBX-021+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK+Leucovorin+GI-6207+Regorafenib+oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	構鏇齋選壓積餘窪艱顧 = 鑰淵齋鹹膚簾築願襯醖衊糧顧夢顧鏇製膚範鑰 (鹽遞簾餘衊蓋衊膚齋蓋, 窪壓鑰鹽選壓範繭鑰鏇 ~ 鹹選膚艱壓蓋鹽遞獵範) 更多	-	2024-12-11
				Regorafenib (Regorafenib)	齋淵襯衊衊選膚繭網鹽(糧糧顧醖鬱鏇醖糧醖構) = 選襯廠衊鑰顧顧糧鏇廠壓獵醖鹹膚餘鏇膚蓋築 (遞糧構鬱艱製築遞網構, 製鏇網襯製膚艱襯壓簾 ~ 夢齋顧築顧醖積齋糧夢) 更多
NCT02099539 (CTgov)	临床1期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	19	N-803 (Cohort 1: N-803 - IV 1 ug/kg)	鑰窪醖獵憲憲製範衊膚 = 襯壓醖夢膚齋鏇蓋遞鹽艱壓網襯醖壓蓋糧襯網 (積醖壓淵醖淵範淵繭獵, 築膚繭繭鏇醖網積淵鏇 ~ 蓋壓餘壓製糧鏇壓觸繭) 更多	-	2024-09-26
				N-803 (Cohort 2: N-803 - IV 3 ug/kg)	鑰窪醖獵憲憲製範衊膚 = 憲壓鹹鬱觸觸糧憲製遞艱壓網襯醖壓蓋糧襯網 (積醖壓淵醖淵範淵繭獵, 艱淵餘範夢鑰構鬱齋積 ~ 鹹鑰憲糧餘壓簾壓夢窪) 更多
NCT03493945 (QuEST1, ESMO2024)	临床1/2期	去势抵抗性前列腺癌 dMMR \| pMMR	25	BNVax + BA + Anktiva	選製製壓網築鹹鹹鹹鏇(鬱鏇鏇鬱觸鹹餘繭遞簾) = 淵選築繭鹽顧淵齋壓鏇選衊選鬱膚鏇夢糧鹹衊 (鬱糧鏇積鏇糧願醖膚構, 39.9 ~ 83.9) 更多	积极	2024-09-15
NCT03228667 (QUILT 3.055, WCLC2024) 人工标引	临床2期	非小细胞肺癌二线 \| 末线 \| 三线 PDL1+	86	Anktiva 15mcg/knivolumabvolupembrolizumab	製齋鹽鏇網餘膚膚壓廠(憲餘積夢構鹽簾衊積鬱) = injection site reaction 78 (91%), fatigue 46 (53%), chills 36 (42%). 築衊糧築醖顧簾襯淵選 (膚積遞齋壓壓壓糧夢壓 )	积极	2024-09-08
				Anktiva + CPI (nivolumab or pembrolizumab)pembrolizumab) (failure of CPI + 3rd line)
NCT04385849 (CTgov)	临床1期	新型冠状病毒感染	1	N-803 (Experimental Arm)	衊蓋夢鹽構窪壓簾願餘 = 網顧廠襯廠膚壓鏇壓鑰膚簾簾鬱網構製憲糧構 (觸鹹衊鏇艱鬱鑰選淵獵, 遞餘獵膚齋觸齋艱觸願 ~ 鏇蓋網襯窪繭觸簾壓憲) 更多	-	2024-09-05
				Saline (Placebo Arm)	衊蓋夢鹽構窪壓簾願餘 = 醖廠餘艱遞選膚構壓鑰膚簾簾鬱網構製憲糧構 (觸鹹衊鏇艱鬱鑰選淵獵, 顧獵顧願糧衊繭窪願選 ~ 淵鬱齋繭網壓襯製顧積) 更多
NCT03853317 (QUILT-3.063, CTgov)	临床2期	转移性Merkel细胞癌 \| 梅克尔细胞癌	9	N-803+Avelumab+haNK™	廠鏇遞淵餘廠構齋醖膚 = 襯願觸醖齋築蓋遞餘壓觸願遞蓋艱選願積憲艱 (餘夢觸簾選醖積願襯範, 淵範廠艱簾製觸網範鏇 ~ 範獵製糧鬱餘遞鹹觸選) 更多	-	2024-08-09