The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are:
1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion
2. Can SNK01 administration improve cognitive assessment scores and biomarkers

开始日期2023-11-21

申办/合作机构

NKGen Biotech, Inc.

NCT05099549 / Terminated临床1/2期

A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers

This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.

开始日期2021-11-03

申办/合作机构

NKGen Operating Biotech, Inc.初创企业

[+1]

NCT04872634 / Unknown status临床1/2期

A Phase I/IIa, Open, Single-Center Clinical Trial Evaluating the Safety and Anti-Tumor Activity of SNK01 (Natural Killer Cells) Administered in Combination With Gemcitabine/Carboplatin or Gemcitabine/Carboplatin/Cetuximab to Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Who Have Failed Prior Tyrosine Kinase Inhibitor (TKI) Therapy (SNK_ASTER)

This clinical trial is a Single-Center, Open, Phase I/IIa Clinical Trial conducted to evaluate the safety and anti-tumor activity of SNK01 and GC +/- Cetuximab administered in combination to Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior Tyrosine Kinase Inhibitor (TKI) therapy at least once.
After the start of the clinical trial, the first 3 subjects complete the enrollment in Cohort 1 in serial order and then 3 subjects are enrolled in Cohort 2 in serial order. After this, Cohorts 1, 3 and Cohorts 2, 4 are independently processed and subjects are enrolled in serial order when new cohorts start and/or replacement subjects are required. For the subjects who are additionally enrolled after the DLT evaluation and the MTD is determined in each dose cohort, no DLT evaluation is conducted.
The subjects allotted to each cohort are administered with the SNK01 manufactured from peripheral blood mononuclear cells total 8 times over a period of about 10 weeks. Combined administration of SNK01 starts from the Cycle 2 (Week 4) of Cytotoxic Chemotherapy and SNK01 is administered at an interval of 1 week starting from the day after the administration of Cytotoxic Chemotherapy and/or Cetuximab (Visit 5-1, D23).
When no disease progression is confirmed at EOT (End of Treatment), disease progression is checked until the clinical trial is over. The adverse events which have occurred during the study period are monitored until the date when the investigator judges that no monitoring is required as the symptom has disappeared or there is no further change in the symptom or the 30th day (±3 d) from the latest date of the administration among Gemcitabine, Carboplatin and Cetuximab after the EOT, whichever comes first.
For all the subjects enrolled in the present clinical trial, safety is checked in accordance with CTCAE V5.0 and effectiveness is checked in accordance with RECIST V1.1 through the vital signs, laboratory test, adverse events, etc. during the study period.

开始日期2021-07-08

申办/合作机构

NKMAX Co., Ltd.

100 项与 Troculeucel 相关的临床结果

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100 项与 Troculeucel 相关的转化医学

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100 项与 Troculeucel 相关的专利（医药）

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项与 Troculeucel 相关的文献（医药）

2024-03-01·Journal for ImmunoTherapy of Cancer

Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical study

Article

作者: Choi, Chang-Min ; Ji, Wonjun ; Choi, Myeong Geun ; Jung, Jae Seob ; Choi, Mi Young ; Kim, Yong Man ; Jo, Jong-Min ; Yoon, Byeong Gon ; Lee, Jae Cheol ; Son, Gun Woo ; Rho, Jin Kyung ; Ko, Dae-Hyun

BackgroundChoosing treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients with osimertinib resistance is challenging. We evaluated the safety and efficacy of SNK01 (autologous natural killer (NK) cells) in combination with cytotoxic chemotherapy and/or cetuximab (an anti-EGFR monoclonal antibody) in treating EGFR-mutated NSCLC in this non-clinical and phase I/IIa clinical trial.MethodsWe developed a cell line-derived xenograft-humanized mouse model with an osimertinib-resistant lung cancer cell line. The mice were divided into four groups based on treatment (no treatment, cetuximab, SNK01, and combination groups) and treated weekly for 5 weeks. In the clinical study, 12 patients with EGFR-mutated NSCLC who failed prior tyrosine kinase inhibitor (TKI) received SNK01 weekly in combination with gemcitabine/carboplatin (n=6) or cetuximab/gemcitabine/carboplatin (n=6) and dose escalation of SNK01 following the “3+3” design.ResultsIn the non-clinical study, an increase in NK cells in the blood and enhanced NK cell tumor infiltration were observed in the SNK01 group. The volume of tumor extracted after treatment was the smallest in the combination group. In the clinical study, 12 patients (median age, 60.9 years; all adenocarcinoma cases) received SNK01 weekly for 7–8 weeks (4×109cells/dose (n=6); 6×109cells/dose (n=6)). The maximum feasible dose of SNK01 was 6×109cells/dose without dose-limiting toxicity. Efficacy outcomes showed an objective response rate of 25%, disease control rate of 100%, and median progression-free survival of 143 days.ConclusionSNK01 in combination with cytotoxic chemotherapy, including cetuximab, for EGFR-mutated NSCLC with TKI resistance was safe and exerted a potential antitumor effect.Trial registration numberNCT04872634.

2022-10-15·Cancer Research and Treatment2区 · 医学

A Phase I/IIa Randomized Trial Evaluating the Safety and Efficacy of SNK01 Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer

2区 · 医学

Article

作者: Kang, Yoonmi ; Ji, Wonjun ; Ko, Dae-Hyun ; Choi, Chang-Min ; Kim, Sang-Yeob ; Choi, Myeong Geun ; Do, Eun-Ju ; Rho, Jin Kyung ; Kim, Eo Jin ; Jung, Jae Seob ; Kim, Dong Ha ; Lee, Jae Cheol ; Kim, Yong Man ; Cho, Yong-Hee

Purpose The aim of this study is to evaluate the safety and efficacy of ex vivo activated and expanded natural killer (NK) cell therapy (SNK01) plus pembrolizumab in a randomized phase I/IIa clinical trial.Materials and Methods Overall, 18 patients with advanced non–small cell lung cancer (NSCLC) and a programmed death ligand 1 tumor proportion score of 1% or greater who had a history of failed frontline platinum-based therapy were randomized (2:1) to receive pembrolizumab every 3 weeks +/– 6 weekly infusions of SNK01 at either 2×109 or 4×109 cells per infusion (pembrolizumab monotherapy vs. SNK01 combination). The primary endpoint was safety, whereas the secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life.Results Since no dose-limiting toxicity was observed, the maximum tolerated dose was determined as SNK01 4×109 cells/dose. The safety data did not show any new safety signals when SNK01 was combined with pembrolizumab. The ORR and the 1-year survival rate in the NK combination group were higher than those in patients who underwent pembrolizumab monotherapy (ORR, 41.7% vs. 0%; 1-year survival rate, 66.7% vs. 50.0%). Furthermore, the median PFS was higher in the SNK01 combination group (6.2 months vs. 1.6 months, p=0.001).Conclusion Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events.

2022-07-01·Thoracic Cancer

Two‐year efficacy of SNK01 plus pembrolizumab for non‐small cell lung cancer: Expanded observations from a phase I/IIa randomized controlled trial

Article

作者: Lee, Jae Cheol ; Kim, Yong Man ; Ji, Wonjun ; Choi, Chang‐Min ; Park, Hyung Jun ; Jung, Jae Seob

AbstractBackgroundA previous trial showed that autologous ex‐vivo expanded NK cell (SNK01) treatment combined with pembrolizumab showed better efficacy than pembrolizumab monotherapy in advanced non‐small cell lung cancer (NSCLC). This study was a 2‐year follow‐up of that previous study to determine the long‐term efficacy of the combination treatment.MethodsThis trial included 20 patients with advanced NSCLC with a PD‐L1 tumor proportion score of 1% or greater who failed prior to front‐line platinum‐based therapy. The patients received pembrolizumab with low‐dose SNK01 (2 × 109 cells/dose) or high‐dose SNK01 (4 × 109 cells/dose), or pembrolizumab monotherapy. The primary study endpoint was overall survival (OS), and the secondary endpoint was progression‐free survival (PFS).ResultsTwo patients were excluded following serious adverse events. Among the 11 patients who died, five were from the NK groups (41.6%, n = 5/12), and six received pembrolizumab monotherapy (100%, n = 6/6). The estimated 2‐year survival rate was 58.3% versus 16.7% (pembrolizumab plus SNK01 vs. pembrolizumab monotherapy). The hazard ratio of pembrolizumab plus SNK01 compared with pembrolizumab monotherapy was 0.32 (95% CI: 0.1, 1.08, p‐value: 0.066). Although the median PFS was significantly higher in the pembrolizumab plus SNK01 group than in the pembrolizumab alone group, OS and PFS did not differ statistically between patients who received low doses of NK cells and those who received high doses of NK cells.ConclusionsAutologous NK cells can enhance the long‐term OS and PFS for NSCLC. A larger study is needed to confirm this result.Clinical Research Information Service number: KCT0003463.

101

项与 Troculeucel 相关的新闻（医药）

2024-11-11

·PRNewswire

NK Cell Therapy Clinical Trial Pipeline Appears Robust With 140+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

NK cell therapy is gaining momentum as a promising solution to unmet medical needs in cancer treatment, offering safer, targeted options for patients unresponsive to traditional therapies. Increased R&D investment, regulatory support, and successful clinical trials have bolstered confidence in these therapies, while technological advances in cell production are set to meet growing demand. Rising cancer rates and heightened public awareness further amplify market potential, making NK cell therapy a pivotal area of growth in oncology. LAS VEGAS, Nov. 11, 2024 /PRNewswire/ -- DelveInsight's ' NK Cell Therapy Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline NK cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NK cell therapy pipeline domain. Key Takeaways from the NK Cell Therapy Pipeline Report DelveInsight's NK cell therapy pipeline report depicts a robust space with 140+ active players working to develop 160+ pipeline NK cell therapies. Key NK cell therapy companies such as Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others are evaluating new NK cell therapies to improve the treatment landscape. Promising NK cell therapies in the pipeline such as Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others are under different phases of NK cell therapy clinical trials. In October 2024, Immunitybio announced that the first patients had been dosed in an initial trial studying the potential of the company's CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL). In July 2024, The U.S. Food and Drug Administration (FDA) gave Nkarta the green light to launch a clinical trial testing its cell therapy candidate NKX019 in people with ANCA-associated vasculitis (AAV) and other autoimmune disorders. In May 2024, KGen Biotech announced that its Safety Review Committee had cleared the Company's cryopreserved autologous, expanded, and enhanced SNK01 to progress into Phase II clinical development. In May 2024, Fate Therapeutics announced that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. In April 2024, Sanofi moved its natural killer (NK) cell engager candidate SAR443579/IPH6101 to a Phase II trial evaluating the drug's use in treating a range of blood cancers. In April 2024, the FDA granted orphan drug designation to the investigational therapy IGNK001 (Gengleucel) for patients with acute myeloid leukemia (AML). In February 2024, Indapta Therapeutics received FDA Fast Track Designation for its natural killer (NK) cell therapy IDP-023 for patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Request a sample and discover the recent advances in the NK cell therapy segment @ NK Cell Therapy Pipeline Report The NK cell therapy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NK cell therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NK cell therapy clinical trial landscape. NK Cell Therapy Overview Natural Killer (NK) cell therapy is an innovative approach in immunotherapy that harnesses the power of NK cells, a vital component of the innate immune system. Unlike T cells, which require prior sensitization to target cancer cells, NK cells can recognize and kill abnormal cells without prior exposure. This unique ability makes NK cell therapy a promising option for treating various cancers, including hematologic malignancies like leukemia and lymphoma, as well as solid tumors. By isolating and activating NK cells from a patient's blood or using engineered NK cells from healthy donors, researchers aim to enhance the immune response against tumors, leading to improved patient outcomes. Recent advancements in genetic engineering, such as the introduction of chimeric antigen receptors (CAR) into NK cells, are further enhancing their specificity and efficacy against cancer cells. The clinical applications of NK cell therapy are expanding rapidly, supported by a growing body of research and early-phase clinical trials. These studies have shown promising results, demonstrating the ability of NK cell therapy to induce durable remissions in patients with refractory cancers. Furthermore, the off-the-shelf nature of certain NK cell therapies allows for quicker treatment deployment compared to traditional CAR-T cell therapies, which require a personalized approach. Challenges remain, including optimizing NK cell expansion, persistence, and overcoming the immunosuppressive tumor microenvironment. However, ongoing research into combination therapies, such as pairing NK cell therapy with checkpoint inhibitors or monoclonal antibodies, is expected to enhance the therapeutic potential of NK cells and provide new hope for cancer patients. Find out more about NK cell therapy @ Novel NK Cell Therapies A snapshot of the Pipeline NK Cell Therapies mentioned in the report: Learn more about the emerging NK cell therapies @ NK Cell Therapy Clinical Trials NK Cell Therapy Therapeutics Assessment The NK cell therapy pipeline report proffers an integral view of the emerging NK cell therapies segmented by stage, product type, molecule type, and route of administration. Scope of the NK Cell Therapy Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule Key NK Cell Therapy Companies: Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others. Key Pipeline NK Cell Therapies: Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others. Dive deep into rich insights for new NK cell therapies, visit @ NK Cell Therapy Drugs Table of Contents For further information on the NK cell therapy pipeline therapeutics, reach out @ NK Cell Therapy Treatment Drugs Related Reports NK Cell Therapy Market NK Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NK cell therapy companies including Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, among others. Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

细胞疗法孤儿药快速通道免疫疗法临床2期

2024-11-02

·药明康德

多款阿尔茨海默病疗法公布亮眼数据；独特基因疗法向FDA重新递交上市申请…… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。Abeona Therapeutics公司向美国FDA重新提交了其自体细胞基因疗法prademagene zamikeracel（pz-cel）的生物制品许可申请（BLA），用于治疗隐性营养不良性大疱性表皮松解症（RDEB）。用于治疗肌萎缩侧索硬化（ALS）的在研细胞疗法debamestrocel公布了积极的扩展研究结果，与外部匹配的对照组相比具有统计学上显著的生存优势。多款用于治疗阿尔茨海默病（AD）的候选CGT疗法公布亮眼早期临床试验数据。临床试验结果本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF ———✦研发进展✦——— ◇ Abeona Therapeutics公司宣布已向美国FDA重新提交了其自体细胞基因疗法pz-cel的BLA，作为隐性营养不良性大疱性表皮松解症患者的一种潜在新疗法。Pz-cel是由患者的自身皮肤细胞经过基因校正后扩增形成的角质细胞片，这些皮肤细胞的基因组中整合了一个功能正常的COL7A1基因以表达胶原蛋白VII，这种蛋白质是形成将表皮连接到真皮的锚纤维所需的。该候选疗法可通过外科手术来覆盖伤口区域，实现持续的伤口愈合和疼痛减轻。此前，pz-cel已获得美国FDA授予的再生医学先进疗法认定、突破性疗法认定、孤儿药资格及罕见儿科疾病认定。 ◇ BrainStorm Cell Therapeutics公司公布了其用于治疗ALS的在研细胞疗法debamestrocel的扩展研究结果。研究结果显示，在扩展使用项目（EAP）的最后一次随访中，10名受试者中有9人存活。生存曲线显示debamestrocel组与外部匹配对照组相比，具有统计学上显著的生存优势，其中debamestrocel组的中位生存时间为46.6个月，而匹配对照组为41.1个月。此外，在6名在3期临床试验期间已接受debamestrocel的患者中，观察到神经丝轻链（NfL）水平持续下降。相比之下，在3期试验中接受安慰剂的患者组中，中位NfL水平增加了37%，表明神经退行性病变加重。然而，这些患者在EAP中接受debamestrocel治疗后，大多数人的NfL水平趋于稳定。 Debamestrocel来源于ALS患者自身骨髓的间充质干细胞，这些细胞在体外进行扩增和分化，并且通过该公司独有的技术刺激分泌高水平的多种神经营养因子。这些分化的细胞在输注回到患者体内后，可能激活神经保护和免疫调节信号通路，从而减轻ALS患者的症状。 ◇ Lexeo Therapeutics公司公布了其用于治疗载脂蛋白E4（APOE4）基因纯合子型阿尔茨海默病的候选基因疗法LX1001的1/2期临床试验数据。结果显示，所有15名接受LX1001治疗的轻度认知障碍（MCI）或轻度或中度AD患者的神经保护性APOE2蛋白表达量呈剂量依赖性增加，12个月后仍具有持续性。大多数受试者的淀粉样病理学趋于稳定，超过三分之二患者的脑脊液（CFS）tau生物标志物（包括CSF T-tau、P-tau181、P-tau2172和P-tau2312）与基线和自然病史相比持续减少。此外，LX1001的安全性良好，没有报告淀粉样蛋白相关成像异常（ARIA）。 LX1001是一种基于AAVrh10的候选基因疗法，用于治疗APOE4基因纯合子型阿尔茨海默病患者。APOE4是APOE基因的一个等位基因，APOE4纯合子个体患阿尔茨海默病的风险大约是普通人群的15倍。而APOE2等位基因纯合子个体患阿尔茨海默病的风险比普通人群低40%。LX1001旨在在APOE4纯合子患者的中枢神经系统中表达具有保护作用的APOE2基因，潜在减缓或阻止阿尔茨海默病的进展。此前，LX1001已被美国FDA授予快速通道资格。 ◇ NKGen Biotech公司公布了其自体增强型自然杀伤（NK）细胞疗法troculeucel用于治疗中度AD的1/2a期临床试验中的1期临床数据。初步结果显示，在给予迄今为止最高剂量（60亿细胞）的冷冻保存的troculeucel的情况下，troculeucel表现出非常高的安全性，没有不良反应。在接受最高剂量治疗的前3名受试者中，100%患者的认知功能稳定或有所改善，并且其中两名受试者在接受仅三个月的治疗后，从中度疾病阶段显著好转至轻度认知障碍。 Troculeucel（SNK01）是一款自体、非基因工程改造的NK细胞产品，它具有增强的细胞毒性，活化受体表达率超过90%，可从任何供体中稳定生产。该候选疗法能够有效降低AD患者CSF中的α-突触核蛋白（α-syn）水平，该蛋白的升高被认为与认知能力下降有关。 ◇ Regeneration Biomedical公司公布了其用于治疗轻度至中度AD患者的自体Wnt激活脂肪来源干细胞（RB-ADSC）的1期临床试验结果。结果显示，该疗法的耐受性良好。第12周时，患者的P-tau和β淀粉样蛋白的水平有所下降。3名受试者中有2名的简易精神状态量表（MMSE）结果显示其认知功能有改善的趋势。 RB-ADSC是Wnt激活的脂肪源性干细胞，取自患者自身的脂肪组织。采集后，干细胞在体外进行培养和扩增，筛选出Wnt表达的干细胞，然后通过植入位于头皮下，可直接进入大脑的一个侧脑室的Ommaya储存器重新输回患者体内。 ◇ 中国国家药监局药品审评中心（CDE）官网公示，石药集团的嵌合抗原受体（CAR）-T细胞注射液SYS6020获得一项新的临床试验默示许可，拟开发治疗难治性全身型重症肌无力。公开资料显示，SYS6020为一款基于mRNA-脂质纳米颗粒（LNP）的CAR-T细胞注射液，也是石药集团布局的首个细胞治疗在研产品。SYS6020通过表达可特异性识别BCMA抗原的CAR，进而靶向识别患者体内BCMA阳性的细胞并对其进行杀灭，从而达到治疗目的。今年6月，SYS6020在中国首次获批临床，拟开发治疗复发或难治性多发性骨髓瘤。8月，SYS6020治疗系统性红斑狼疮（SLE）适应症获批临床，本次是该产品再次获得自身免疫疾病IND许可。 ◇ CDE官网公示，由艺妙神州全资子公司再妙生物与阳光诺和合作开发的CAR-T药物ZM001注射液获批临床，拟开发治疗SLE。根据新闻稿，ZM001通过特异性清除SLE患者体内的B细胞，抑制体内自身抗体的产生，缓解脏器中免疫复合物的沉积，并能够使机体重建正常的B细胞，进而缓解红斑狼疮症状，并维持长期疗效，是一种潜在的中度和重度SLE治疗药物。在此前进行的临床前研究中，ZM001展现出了清除B细胞快速且持续性的疗效，以及极低的严重不良反应发生率。 ◇ 普罗凯融生物申报的1类新药MSCohi-O镜片获批临床，拟开发治疗慢性眼部移植物抗宿主病（coGVHD）。根据普罗凯融生物公开资料介绍，这是其开发的负载间充质干细胞的高透氧水凝胶镜片。其核心创新性是解决脐带间充质干细胞自身无法停留在眼表的瓶颈障碍，实现稳定的眼表局部给药，从机理上治疗免疫相关的眼科疾病。该产品此前已经获得美国FDA授予孤儿药资料，用于治疗oGVHD。移植物抗宿主病是一种多系统疾病，其中眼部移植物抗宿主病会严重影响患者的视力，干预不及时还会导致患者失明。 ◇ 华道生物1类新药HD004细胞获批临床，拟用于治疗CLDN18.2表达阳性的晚期实体瘤伴恶性腹腔积液。根据华道生物公开资料，这是华道生物研发的靶向CLDN18.2的自体CAR-T产品。HD004细胞通过腹腔内灌注给药方式更直接靶向腹腔中的肿瘤细胞以发挥抗肿瘤作用，可以一定程度克服实体瘤CAR-T疗法障碍，提高CAR-T细胞运输和肿瘤浸润效率，在肿瘤局部停留时间延长，并且降低了脱靶效应带来的风险。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Lexeo Therapeutics Announces Positive Interim Data for LX1001, First-Ever Gene Therapy to Impact the Underlying Genetic Cause of APOE4-Associated Alzheimer’s Disease, at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference. Retrieved November 1, 2024, from https://ir.lexeotx.com/news-releases/news-release-details/lexeo-therapeutics-announces-positive-interim-data-lx1001-first [2] NKGen Biotech Presents Phase 1/2a Troculeucel Data in Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference. Retrieved November 1, 2024, from https://www.globenewswire.com/news-release/2024/10/29/2970775/0/en/NKGen-Biotech-Presents-Phase-1-2a-Troculeucel-Data-in-Alzheimer-s-Disease-at-the-17th-Annual-Clinical-Trials-on-Alzheimer-s-Disease-CTAD-Conference.html [3] Regeneration Biomedical Presents Data on First Cohort from an Ongoing Phase I Clinical Trial of Stem Cell Therapy Delivered Directly into the Brains of Patients with Alzheimer’s Disease. Retrieved November 1, 2024, from https://www.globenewswire.com/news-release/2024/10/29/2970530/0/en/Regeneration-Biomedical-Presents-Data-on-First-Cohort-from-an-Ongoing-Phase-I-Clinical-Trial-of-Stem-Cell-Therapy-Delivered-Directly-into-the-Brains-of-Patients-with-Alzheimer-s-Di.html [4] Abeona Therapeutics® Completes Pz-cel Biologics License Application Resubmission to U.S. Food and Drug Administration. Retrieved November 1, 2024, from https://www.globenewswire.com/news-release/2024/10/29/2970698/0/en/Abeona-Therapeutics-Completes-Pz-cel-Biologics-License-Application-Resubmission-to-U-S-Food-and-Drug-Administration.html [5] BrainStorm Cell Therapeutics Presented Positive Survival Data from NurOwn® Expanded Access Program at 2024 Annual NEALS Meeting. Retrieved October 28, 2024, from https://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-presented-positive-survival-data-from-nurown-expanded-access-program-at-2024-annual-neals-meeting-302288404.html [6] 自愿公告 - 首款基於mRNA-LNP的CAR-T细胞注射液(SYS6020)再获新适应症临床试验批准. Retrieved October 25, 2024, from http://www.cninfo.com.cn/new/disclosure/detail?stockCode=01093&announcementId=1221524554&orgId=gshk0001093&announcementTime=2024-10-25 [7] 进军自免 | 艺妙神州治疗系统性红斑狼疮的CAR-T药物获得临床试验通知书. Retrieved October 29, 2024, from https://mp.weixin.qq.com/s/x8WT9y2BSVT-o26Luzfl3A 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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：本文来自药明康德内容团队，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

孤儿药基因疗法临床结果细胞疗法突破性疗法

2024-10-31

·药融圈

你知道细胞疗法在非肿瘤领域的6个重磅研发方向吗？

免疫细胞治疗通过激活或增强机体的免疫系统，在肿瘤治疗领域具有划时代意义，为癌症治疗带来了深远的影响。免疫细胞治疗能够弥补传统肿瘤治疗方法的不足，如手术无法完全清除微小病灶、放疗和化疗对正常细胞的损伤等。它可以帮助清除手术后残留在体内的肿瘤细胞，减少术后复发和转移的风险。同时免疫细胞治疗还可以与其他治疗方法如放疗和化疗联合应用，发挥协同抗肿瘤效应，提高治疗效果。近年来，免疫细胞治疗在肿瘤临床应用中取得了显著进展。例如，CAR-T细胞疗法已经在多种血液系统肿瘤和部分实体瘤患者中显示出良好的疗效。同时近年来，免疫细胞治疗在非肿瘤领域也取得很多突破，例如在自身免疫疾病、感染性疾病、衰老等，未来非肿瘤领域或许是免疫细胞治疗更大的用武之地与市场所在。 01 自身免疫类疾病 1 SLE（系统性红斑狼疮） SLE（系统性红斑狼疮）一直是临床的难题，传统治疗方法包括糖皮质激素、免疫抑制剂和生物制剂等，在部分重度和难治性患者中的效果非常有限。CAR-T疗法通过靶向B细胞分化产生的自身抗体，达到深度清除致病性B细胞的效果，从而触发免疫“重置”，实现完全缓解疾病，许多患者在接受治疗后无需再使用羟氯喹、激素或免疫抑制剂，达到了接近一次性治愈的效果。 2021年8月，德国埃尔朗根-纽伦堡大学的研究人员在《新英格兰医学杂志》（NEJM）发表研究论文，对一名患有严重系统性红斑狼疮的20岁女性患者进行了CAR-T细胞治疗，这是世界上首次使用CAR-T细胞疗法来治疗系统性红斑狼疮。从治疗后的第三周开始，患者的肾脏和红斑狼疮指标有所改善，所有症状逐渐消失了，治疗团队表示，之前从未有任何药物达到过这种效果。2023年7月底，CAR-T细胞治疗仅仅一个月后，患者已经可以回家了，开始了正常的生活。如今已经一年多了，患者保持良好状态。相关研究成果发表在《柳叶刀》（The Lancet）。目前国内多家企业也在快速推进此领域的研究。 2 难治性风湿免疫疾病难治性风湿免疫疾病是临床难题之一。近年通用型CAR-T细胞疗法带来了新的希望。今年7月16日，我国上海长征医院风湿免疫科的徐老师团队，发布了一项令人瞩目的临床研究结果，三名患有严重复发难治性风湿免疫疾病的患者，在接受通用型CAR-T疗法后，病情得到了明显的改善。这一研究的成果于2024年7月15日晚在线发表在《Cell》上是国际上首次报道通用型CAR-T成功治疗自身免疫疾病的研究成果。标志细胞治疗在该领域的临床研究迈出了突破性的一步。 3 阿尔兹海默病阿尔兹海默症（俗称老年痴呆症），是一种非常常见的神经退行性疾病。这种疾病主要影响65岁以上的老年人。患者基数巨大，给患者急社会带来巨大的痛苦，当前临床期待更强效的治疗方案，或许免疫细胞疗法能带来更多选择。研究人员成功在阿尔茨海默病患者中测试了一种名为 SNK01 的免疫细胞疗法的有效性。SNK01是一款非基因修饰的自体NK细胞疗法，其在采集患者的血液后从中分离并筛选出目标NK细胞，再激活NK细胞并促使其扩增。这是一种增强型自然杀伤细胞，可表达激活受体并显示出显着的细胞毒性。这种治疗可以穿过血脑屏障，血脑屏障是防止毒素进入中枢神经系统的一层细胞。在I期临床试验中，10名阿尔茨海默病患者接受了SNK01的NK细胞治疗。研究的最终数据，进一步证明SNK01耐受性良好，似乎可以降低患者的阿尔茨海默症血液标志物:Aβ42/40淀粉样蛋白，并减轻神经炎症。使用ADCOMS评分显示，90%的患者11周后表现出改善或保持稳定的认知功能，这表明SNK01不止局限于减缓疾病进展。华盛顿医学院研究者们系统地比较了淀粉样蛋白沉积或tau聚集和神经退行疾病的小鼠大脑中的免疫环境。他们的研究结果揭示了在tau病和神经变性中，激活的小胶质细胞和T细胞相互作用的免疫中枢，可以作为预防阿尔茨海默病和原发性tau病的神经退行性变的治疗方法。 02 抗衰老领域几千年来抗衰老是人类永恒的需求。预计到2030年，65岁以上的老年人将占世界人口的20%。衰老细胞在生命早期就被免疫系统生理清除，利用增强免疫细胞并延长这一过程可能使机体获得更大收益。《自然衰老》杂志发表了抗衰老领域的一项新突破。科学家发现，单次注射由CAR-T细胞组成的抗衰老疗法可以延缓或逆转衰老的特征，并可能在数年内继续提供这些益处。这种方法改善了年老机体的运动能力和代谢功能障碍，如葡萄糖耐量。这项新研究的不同之处在于，它将CAR-T免疫细胞视为一种预防和治疗与衰老相关的变化的方法。此外，这些细胞的持久性表明，即使是一次给药也可能能够治疗与年龄有关的慢性疾病。基于这些突破性成果，研究人员正在寻找能让机体更健康且活得更久的新方案。随着科学研究的进展，科学界离人们梦寐以求的青春之泉又近了一步。 1 巨噬细胞巨噬细胞是免疫系统中的关键细胞，它们通过吞噬作用清除凋亡细胞和衰老细胞，防止炎症和组织损伤。在动脉粥样硬化等疾病中，巨噬细胞的这种清除功能受损，可能导致疾病的进展。 2 自然杀伤（NK）细胞 NK细胞是免疫系统中的另一类重要细胞，它们通过识别衰老细胞表面的特定分子（如MICA/B和ULBP2）来清除衰老细胞。NK细胞的这种清除功能对于防止肿瘤发展和慢性炎症至关重要。 3 T细胞 T细胞，特别是CD8+细胞毒性T细胞，可以通过识别衰老细胞表面的MHC I分子来直接杀死衰老细胞。此外，通过基因工程改造的CAR-T细胞（嵌合抗原受体T细胞）可以被设计为特异性地识别和清除表达特定抗原的衰老细胞。 4 树突状细胞树突状细胞是专业的抗原呈递细胞，它们可以吞噬衰老细胞并将其抗原呈递给T细胞，从而激活适应性免疫反应。 03 脏器纤维化最近的临床前研究表明， CAR-T 细胞可以针对纤维化并在高血压损伤后恢复心脏功能。研究人员注入 anti-FAP CAR-T 细胞可以在心脏损伤后解决纤维化问题，并改善心脏功能。肝脏疾病、慢性肾脏疾病、肺部疾病、骨骼肌疾病等许多其他情况都可以尝试使用抗纤维化 CAR-T 细胞进行治疗。今年安徽医科大学第一附属医院王华教授团队在Journal of Hepatology上发表题为Chimeric antigen receptor-modified macrophages ameliorate liver fibrosis in preclinical models的研究论文，该研究首次提供了临床前证据，证明靶向uPAR的CAR-Ms可以减轻肝纤维化。在上文提到的，我国上海长征医院风湿免疫科的徐老师团队，三名患有严重复发难治性风湿免疫疾病的患者，在接受通用型CAR-T疗法后，还有一个新的发现：CT和核磁共振显现心肺等重要器官的纤维化实现损伤逆转，并在6个月的随访期间持续改善。临床通常认为，器官的纤维化是很难逆转的，这个试验貌似打开了脏器纤维化逆转改善，新的一扇窗。 04 抗感染 CAR-T的初衷是为了治疗HIV感染病人。随着 CAR-T 结构的优化，基于二代结构的 CAR-T 也被应用于 HIV 的治疗，相关的临床实验正在积极开展。同时近期研究测试了 CAR-T 细胞对抗侵袭性肺曲霉病的功效，表明该 CAR-T 细胞在体外和侵袭性肺曲霉病小鼠模型中均显示出抗真菌特性。目前已有临床研究探讨了 NK 细胞在治疗 HPV 病毒感染中的应用。不少试验表明应用 NK 细胞过继免疫疗法可有效地阻止癌症前状态的进展，对于 CIN 早期与宫颈原位癌的患者具有良好的控制与治疗作用。 2023年8月，国际知名期刊《Open Life Sciences》上曾报道一位肺癌继发败血症患者的案例，患者陷入昏迷状态在采用NK细胞疗法治疗后，逐渐苏醒并恢复身体功能。虽然CAR-T 在慢性感染方面有着广阔的发展空间，但是对于急性感染，需要紧急反应，当前 CAR-T 离体生产过程还需进一步优化，通用型免疫细胞治疗或是一种更好的选择。 05 传染性疾病 2022年，《科学转化医学》（Science Translational Medicine）杂志发表文章，科研人员在这篇文章中也表示，NK细胞是抗病毒的天然武器，在临床研究中也已经证明NK细胞对这类病毒（如甲型流感病毒、新冠病毒、乙肝病毒、丙肝病毒、艾滋病毒等）均有效。还有研究表明，甲型流感病毒为了防止体内免疫细胞的干扰，它会释放一种名为PB1-F2毒性蛋白从而抑制NK细胞的招募，减少体内NK细胞的数量，从而增加其发病率和致死性。未来NK细胞有望代表一种新型的抗病毒治疗方法。 06 代谢系统疾病早在几年前，《Science》就有文章大胆预测：调节性T细胞将成为细胞治疗的下一个前沿领域。在治疗代谢性疾病2型糖尿病的过程中，免疫细胞疗法的目标是纠正失衡的免疫状态，保护β细胞免受自身免疫攻击。当前有些研究报告显示，采用免疫调节T细胞疗法后，部分糖尿病前期患者的血糖水平得以稳定，减少了胰岛素需求。你知道细胞疗法在非肿瘤领域的6个重磅研发方向吗？作者 | Yang 审核编辑 | Dr. Tuu ▎2024国际药物研发论坛推荐瞄准全球最前沿的创新技术，由中关村生命科学园发起的2024国际药物研发论坛将于11月22日在北京召开，聚焦创新药物研发和可持续发展，围绕细胞与基因治疗药物研发及产业化、靶向肿瘤药物的研究进展探讨如何整合各方资源，在新技术上、新靶标、新机制、新化合物等方面寻求突破，打通“基础研究-新药创制-成果转化”三大环节之间的壁垒，努力建设新药创制生态圈，推动我国新药创制事业的源头创新、持续创新和循环创新。本次论坛邀请了来自中国、英国、日本、瑞士、美国的顶尖基础研究及药物研发领域的科学家，包括罗敏敏教授，Adil Mardinoglu 教授，Shuai Ke教授，Minoru Takasato教授，Maya Zhang博士，Bernd Wollscheid教授，王军研究员等国内外知名专家出席，针对创新药物新技术研究，细胞基因疗法开发，靶向肿瘤药物研究带来最前沿的分享。 *议程以现场实际为准扫码报名国际峰会了解最新源头创新 2023年国际药物研发论坛往期回顾：

细胞疗法免疫疗法临床研究临床结果ASH会议

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
结直肠癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
EGFR阳性非小细胞肺癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
食管癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
HER2阳性胃癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
肿瘤转移	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
卵巢癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
肉瘤	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
头颈部鳞状细胞癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
宫颈癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01

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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


NCT06189963 (GlobeNewswire) 人工标引	临床1/2期	阿尔茨海默症	3	SNK01	(餘鬱築製積蓋願遞艱夢) = 鬱願願齋夢鹹獵餘醖醖選夢壓鏇願選夢鹽憲壓 (繭鏇壓衊餘壓鏇蓋鬱窪 ) 更多	积极	2024-10-29
NCT04678453 (GlobeNewswire) 人工标引	临床1期	阿尔茨海默症	11	Troculeucel	(膚餘壓鑰製積鹽鏇鹹鹽) = 90% of all evaluable subjects had either stable or improved (±0.1). 膚構蓋艱蓋鏇願廠構齋 (膚範淵齋膚糧憲製遞範 ) 更多	积极	2024-10-29
NCT04872634 (Pubmed) 人工标引	临床1/2期	EGFR突变的非小细胞肺癌	12	SNK01 + gemcitabine + carboplatin±cetuximab	(窪憲憲鏇襯蓋鬱淵糧糧) = 觸構廠遞鏇顧願衊鹹遞窪遞製糧醖遞壓製簾蓋 (蓋艱齋積鬱憲簾製醖網 ) 更多	积极	2024-03-27
NCT04678453 (GlobeNewswire \| Corporate Publications) 人工标引	临床1期	阿尔茨海默症 cerebral spinal fluid (“CSF”) and plasma Tau proteins	11	SNK01	(鹹範鏇鑰願鑰範艱範窪) = 選窪窪製齋鏇製糧鹽蓋遞願網簾膚獵餘夢夢壓 (構願鹹壓壓鹽蓋憲網鹽 ) 更多	积极	2024-03-25
Corporate Publications 人工标引	临床1期	阿尔茨海默症	10	SNK01	(襯鹽衊積遞繭網網醖鬱) = 壓積蓋蓋淵衊獵衊壓餘襯顧鏇衊鏇蓋醖範廠積 (遞鏇夢積範選餘積衊顧 ) 更多	积极	2023-10-26
NCT05099549 (ASCO_Breakthrough2023) 人工标引	临床1期	EGFR 突变实体瘤 EGFR Expressing	6	AFM24+SNK01	(糧簾選艱鬱夢顧鏇鹽範) = 齋膚製餘鏇鏇膚膚糧衊憲網膚製膚蓋夢壓選膚 (遞鬱醖衊衊簾夢鑰簾製 )	积极	2023-08-03
ESMO2022	N/A	肉瘤	8	SNK01 + Pembrolizumab	(繭膚齋觸廠鏇顧範艱鏇) = 壓顧齋糧餘衊壓構願壓築觸醖築膚夢窪淵憲遞 (範遞廠構膚範鹹壓憲餘 )	-	2022-09-10
WCLC2022	临床1/2期	非小细胞肺癌	20	Pembrolizumab + SNK01 (2 x 10^9 cells/dose)	(蓋廠憲蓋獵鑰選糧糧糧): HR = 0.32 (95% CI, 0.1 ~ 1.08), P-Value = 0.066 更多	-	2022-08-06
WCLC2022	临床1/2期	非小细胞肺癌	20	Pembrolizumab monotherapy		-	2022-08-06
NCT03941262 (ASCO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	10	SNK01	(範網觸餘窪餘鑰膚積壓) = 積艱蓋衊齋鬱顧獵餘繭窪壓製獵衊憲壓網鬱遞 (鬱築築廠蓋夢願夢範膚 ) 更多	积极	2022-06-02
NCT03941262 (ASCO2022)	临床1期	难治性软组织肉瘤	15	SNK01 + Avelumab	(鏇艱蓋衊鑰願繭簾糧淵) = 襯壓願製製淵衊襯餘觸夢鬱鹽淵淵鏇齋選糧艱 (廠願遞範構遞鑰窪簾糧 ) 更多	-	2022-06-02