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 Biotech, Inc.

[+1]

KCT0006109

/ Recruiting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)

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

Background:

Choosing 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.

Methods:

We 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.

Results:

In 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.

Conclusion:

SNK01 in combination with cytotoxic chemotherapy, including cetuximab, for EGFR-mutated NSCLC with TKI resistance was safe and exerted a potential antitumor effect.

Trial registration number:

NCT04872634.

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

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

Abstract:

Background:

A 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.

Methods:

This 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).

Results:

Two 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.

Conclusions:

Autologous 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.

123

项与 Troculeucel 相关的新闻（医药）

10 小时之前

·PipelineReview

NKGen Biotech and HekaBio Enter Strategic Partnership to Bring Novel NK Cell Therapy to Japan

In connection with HekaBio’s recently announced strategic investment in NKGen, the partnership will expedite the regulatory, manufacturing, and commercial development of NKGen’s autologous NK cell therapy, troculeucel, in Japan. Under Japan’s Regenerative Medicine guidelines, cell therapies enjoy a regulatory environment with multiple paths for expedited commercialization. Troculeucel is well positioned to be the first-in-class forerunner for the treatment of several intractable neurodegenerative diseases. SANTA ANA, CA, USA I July 17, 2025 I NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, and HekaBio K.K., headquartered in Chuo-ku, Tokyo (“HekaBio”), announced a strategic partnership to accelerate the regulatory, manufacturing and commercial development of NKGen’s autologous NK cell therapy, troculeucel, in Japan following HekaBio’s recently announced investment in common equity of NKGen. HekaBio will lead all clinical trials in Japan and oversee all regulatory activities with Japan’s Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel in several neurodegenerative disease indications, including Alzheimer’s and Parkinson’s Diseases. As troculeucel is an autologous, non-genetically modified cell therapy, there is allowance under regenerative medicine regulations in Japan to offer this therapy to patients on an accelerated path, much faster than in other major markets. HekaBio will fully leverage the regulation and its domestic strategic partner network, aiming for first dosing in Japanese patients over the next 12 months. Beyond intractable disease, troculeucel has the potential to also support Japan’s aging population in the longevity/wellness space. “Japan has always had an advanced progressive health care system where great attention has been placed on the use of novel autologous cell therapies for prevention, longevity, and wellness as well as for the treatment of more chronic illnesses,” said Paul Y. Song, MD, Chairman and Chief Executive Officer (“CEO”) of NKGen. “I am convinced that HekaBio’s clinical, regulatory, and commercial expertise will guide us to satisfy all regulatory requirements, find the best local manufacturing partner to make our therapy readily available, and ultimately develop the best commercial strategy for Japan. We are very excited to partner with HekaBio.” “Dementia, particularly Alzheimer’s Disease, and other neurodegenerative diseases together present significant health and social challenges in Japan due to the country’s aging population. We are very excited about our partnership with NKGen and look forward to advancing troculeucel for the benefit of patients and society,” said Rob Claar, CEO of HekaBio. About NKGen Biotech NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com . About Troculeucel Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name (“INN”) for SNK01 assigned by the World Health Organization (“WHO”). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market. About HekaBio HekaBio is a Japan-based healthcare platform that accelerates patient access to global medicines and MedTech across Asia-Pacific. HekaBio reviews over 200 assets annually to in-license a select few, focusing on early-stage yet de-risked opportunities in CNS, oncology and healthy longevity. HekaBio synchronizes U.S. and Japan development timelines and leverages strategic partnerships to optimize commercial success. Japan, the world’s third-largest healthcare market, serves as its launchpad for regional expansion. To learn more about HekaBio’s mission and portfolio, please visit www.heka.bio . SOURCE: HekaBio

免疫疗法细胞疗法临床研究

2025-07-17

·今日头条

301医院综述证实：NK疗法暴击肝癌、肺癌、脑瘤等，八成病情受控

肿瘤免疫治疗通过增强患者自身免疫功能实现长期抗肿瘤效果，为传统疗法不佳的肿瘤患者提供了新策略与有效辅助。近期，中国人民解放军总医院第一医学中心（301医院）团队在《临床输血与检验》发表综述指出，NK 细胞不仅在血液系统肿瘤治疗中收效显著，更在实体肿瘤领域潜力巨大。研究显示，自然杀伤细胞（NK细胞）疗法对肝癌、肺癌、乳腺癌及鼻咽癌等实体瘤疗效显著，其中肝癌、肺癌治疗领域表现突出，晚期肝细胞癌疾病控制率高达81.8%，肺癌2年生存率更是暴涨41.6%。这一突破为实体瘤治疗开辟新路径，让我们在对抗恶性肿瘤的征途上看到了更明亮的希望之光，也为无数患者的生命续航注入了强大动力！下面小编为大家简单介绍一下综述的核心内容，让大家在抗癌路上多一份希望与选择！ ▲截图源自“JCTLM” 从天然免疫到利刃出鞘，NK细胞奏响抗癌新强音！（一）NK细胞兼具高效、安全、低成本三重硬核实力自然杀伤细胞（nature killer cell，NK 细胞）作为机体天然免疫的核心细胞，在抗肿瘤、抗病毒感染及免疫调节中发挥关键作用。它既能像 T 细胞那样经工程化改造实现肿瘤靶向治疗，又可通过同种异体输注突破 T 细胞自体来源受限与异体免疫排斥的局限。NK细胞五大核心抗癌优势： 1、NK 细胞作为固有免疫细胞，具有固有的自然杀伤能力，无需激活和抗原识别，通过受体调控免疫功能，可直接杀伤肿瘤细胞和病毒感染细胞。 2、其杀伤机制对特异性抗体依赖度低，无免疫排斥风险，且异体回输安全性已获证实。 3、细胞受受体激活与抑制调节，信号通路较多，容易被调节和改造。 4、可形成记忆性NK细胞，达到长期抗肿瘤免疫。 5、抗肿瘤范围广，适用多种血液系统肿瘤和实体瘤。 6、来源丰富、无需个性化定制、细胞产品成本显著低于动辄百万的 T 细胞疗法，适用患者群体广泛，且患者接受度更高。综上，临床前研究与试验进一步证实，NK 细胞凭借杀瘤速度、效力及适用性优势，为新型免疫治疗开辟了全新领域。（二）NK细胞疗法在实体瘤与血液肿瘤治疗中，斩获突破性进展根据近年中国国家药监局（NMPA）、Clinical trials.gov 等平台数据及研究进展分析，NK 细胞过继免疫疗法（含自体与异体回输）已在恶性肿瘤治疗中取得多项突破性进展： 1、在血液系统肿瘤中收效显著，与PD-1/PD-L1抗体等免疫检查点抑制剂联合使用时，对耐药性肿瘤疗效突出。 2、针对胃癌、结直肠癌、胰腺癌等实体瘤的临床试验显示，部分患者实现肿瘤抑制或缩小。其中，FDA批准的体外CB-NK细胞联合西妥昔单抗治疗结直肠癌微小残留病的IB期临床试验，初步验证了其安全性与有效性。 3、通过脑室注射NK细胞辅助放疗，治疗儿童脑室膜瘤、复发性成神经管瘤的疗效已获证实。 4、NK细胞治疗晚期肝癌的疾病控制率可达80%。 5、针对鼻咽癌、非小细胞肺癌、乳腺癌等易转移实体瘤，近年已从单纯回输转向与其他药物联合的辅助治疗。 6、NK细胞治疗晚期肾细胞癌、黑色素瘤中，未观察到严重不良事件。 ▼NK细胞在治疗恶性肿瘤临床研究中的应用进展 ▲数据源自“临床输血与检验”，全球肿瘤医生网医学部整理汇总 301综述聚焦NK 细胞新进展：横扫肝癌、肺癌、乳腺癌、鼻咽癌、儿童脑肿瘤等，抗癌版图持续扩张！（一）NK细胞联合肝动脉灌注化疗显神威！局部晚期肝癌疾病控制率直冲81.8% 近年研究发现，NK细胞作为肝脏先天免疫系统的核心组成部分，占肝内淋巴细胞的30%~50%。《癌症免疫与免疫治疗》杂志报道的I期临床研究（KCT0003973），针对11例标准治疗无效的局部晚期肝细胞癌（HCC）患者，采用局部区域高剂量自体NK细胞（VAX-NK/HCC）联合肝动脉灌注化疗方案治疗，取得了惊艳疗效。结果显示：全部入组患者的客观缓解率（ORR）达63.6% ，其中完全缓解（CR）率达36.4%、部分缓解（PR）率达27.3% ，疾病控制率（DCR）更是高达81.8% ，这也意味着超八成患者在接受NK细胞+HAIC治疗后，病情得到明显控制。此外，7例达到完全或部分缓解的患者，中位缓解持续时间（DOR）为8.6个月（范围：4.3–27.5个月）（详见下图）。 ▲图源“Front Immunol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除在生存数据方面，中位无进展生存期（PFS）为10.3个月（95%CI：6.8–13.7）， 12个月和24个月PFS率分别为36.4% vs 9.1% （详见下图A）。中位总生存期（OS）长达41.6个月（95%CI：16.0–67.2）， 12个月和36个月OS率分别达72.7% vs 54.5% （详见下图B）。 ▲图源“Front Immunol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除综上，对于标准治疗无效的局部晚期HCC患者，肝动脉灌注化疗联合局部区域高剂量NK细胞疗法安全且疗效显著。（二）从耐药到持续缓解！NK细胞联合曲妥珠单抗，让晚期HER2阳性乳腺癌病情稳定超半年，肿瘤标志物显著下降《临床癌症研究》曾报道一项Ⅰ期临床研究，探索自体NK细胞联合曲妥珠单抗治疗HER2阳性乳腺癌的疗效。该研究纳入19例18~75岁、对标准治疗耐药的HER2阳性晚期乳腺癌患者，均接受NK细胞治疗。结果显示：6例患者达到病情稳定（SD），且持续时间≥6个月（范围6~12个月）。尤为值得关注的是，一位55岁的转移性激素受体阳性/HER2阳性转移性乳腺癌患者，在既往接受过抗HER2治疗、激素疗法及多种化疗后，经连续2个周期NK细胞输注达到部分缓解（PR），并在第8周期治疗后仍维持这一疗效（详见下图）。同时，其肿瘤标志物CA-153水平从治疗前的146.8降至第5周期的75.4 ，治疗结束时稳定在76.6。 ▲图源“AACR”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（三）一线铂类失败别放弃！SNK01NK细胞+帕博利珠单抗强强联合，让晚期肺癌2年生存率暴涨41.6% 近期，一款自体体外扩增NK细胞（SNK01）引发广泛关注。《Thorac Cancer》杂志同步发表的研究显示，SNK01与帕博利珠单抗联合治疗，为一线铂类药物治疗失败的非小细胞肺癌（NSCLC）患者带来新希望。该研究（KCT0003463）纳入20例PD-L1肿瘤比例评分≥1%的晚期非小细胞肺癌（NSCLC）患者（均为一线铂类治疗失败人群），分别接受帕博利珠单抗联合低剂量SNK01（2×10⁹个细胞/剂）、高剂量SNK01（4×10⁹个细胞/剂）治疗，或帕博利珠单抗单药治疗。结果显示：与单药组相比， SNK01联合治疗使患者2年总生存率（OS）显著提升41.6% —— 单药组2年OS率仅为16.7%，而联合治疗组则高达58.3% 。与既往研究结果一致，联合治疗组的中位无进展生存期（PFS）长于单药组，预计2年无进展生存率分别为33.3%（联合组） vs 16.7%（单药组）。 ▲图源“WILEY Online Library”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（四）首次人体研究传捷报！NK细胞脑室内输注安全可行，儿童脑肿瘤病灶缩小近30% 复发性儿童髓母细胞瘤和室管膜瘤预后较差。《神经肿瘤学》报道的一项首次人体I期研究纳入9例中位年龄为11岁7个月（范围8-18岁）的患者，包括5例髓母细胞瘤、4例室管膜瘤，入组后均接受NK细胞输注治疗。其中1例患者（患者8）的疗效尤为值得关注：经5次NK细胞输注后，脑室内肿瘤出现短暂放射学反应， MRI显示病灶缩小近30%，评估为病情稳定（SD）。患者接受2天短期类固醇治疗后暂停一剂NK细胞，10天后复诊时头痛症状出现，局部MRI检查显示病灶进一步缩小（图2A-C）。 ▲图源“Neuro Oncol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除该研究证实了脑室内输注自体NK细胞的可行性与安全性，为儿童脑恶性肿瘤局部区域NK细胞输注治疗的深入研究提供了重要支持。（五）告别严重毒性困境！NK细胞+西妥昔单抗让鼻咽癌患者病情稳定超1年半，症状显著改善鼻咽癌（NPC）患者经放疗、化疗等多学科治疗后，仍有约20%会出现局部区域或远处复发，而重复放化疗毒性显著，美国国家癌症研究所统计发现，约30%接受再次放疗的局部复发患者会出现4~5级严重毒性。因此，急需更有效且低毒的治疗方案，近年研发的NK细胞等免疫疗法为这类患者带来了新选择。《癌症免疫疗法》报道了一项“应用NK细胞+西妥昔单抗联合治疗鼻咽癌I期临床研究（NCT02507154）”的振奋数据。该研究共纳入7例≥21岁的复发性鼻咽未分化癌患者，入组接受扩增NK细胞+西妥昔单抗联合治疗。结果显示： 4例达到病情稳定（SD），其中 3例在末次随访（22~32个月后）仍存活。尤为值得关注的是，1例IVA期患者因肿瘤侵犯左眼眶尖和海绵窦导致动眼神经麻痹，经NK细胞回输后，眼睑下垂等麻痹症状明显改善（详见下图c）。完成6个周期治疗后病情持续稳定（详见下图b），且在无需进一步治疗的情况下，稳定期维持长达19个月。 ▲图源“Cancer Immunol Immunother”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语 NK细胞可在第一时间发现并启动人体的免疫防御机制，及时发现并将癌细胞扼杀在“摇篮”里，是公认的抗癌第一道防线。多项临床研究也表明，NK 细胞疗法具有很高的安全性和有效性，可以实现强效、通用和现成的免疫细胞疗法的前景，克服 CAR-T 疗法的部分缺点，是抗癌疗法中冉冉升起的新星！全球肿瘤医生网小编也希望通过这篇文章能让更多病友，了解到NK细胞疗法的前沿进展及其在实体瘤和血液肿瘤中的应用，为广大癌友带来新的希望与选择！参考资料 [1]Tengyu C A O,et al.Current Trends in NK Cell Immunotherapy for Malignant Tumors[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2024, 26(2): 267. http://www.lcsxyjy.com/CN/10.3969/j.issn.1671-2587.2024.02.017 [2]Bae WK,et al.A Phase I Study of Locoregional High-Dose Autologous Natural Killer Cell Therapy With Hepatic Arterial Infusion Chemotherapy in Patients With Locally Advanced Hepatocellular Carcinoma. Front Immunol. 2022 Jun 2;13:879452. https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.879452/full [3]Park HJ,et al.Two-year efficacy of SNK01 plus pembrolizumab for non-small cell lung cancer: Expanded observations from a phase I/IIa randomized controlled trial. Thorac Cancer. 2022 Jul;13(14):2050-2056. https://onlinelibrary.wiley.com/doi/10.1111/1759-7714.14523 [4]Khatua S,et al.Phase I study of intraventricular infusions of autologous ex vivo expanded NK cells in children with recurrent medulloblastoma and ependymoma. Neuro Oncol. 2020 Aug 17;22(8):1214-1225. https://pmc.ncbi.nlm.nih.gov/articles/PMC7594549/ [5]Lim CM,et al.Phase I study of expanded natural killer cells in combination with cetuximab for recurrent/metastatic nasopharyngeal carcinoma. Cancer Immunol Immunother. 2022 Sep;71(9):2277-2286. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10992008/ 本文为全球肿瘤医生网原创，未经授权严禁转载

细胞疗法免疫疗法临床研究

2025-07-11

·细胞基因治疗前沿

NKGen Biotech：为一名AD患者完成首剂NK细胞疗法注射

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。7月10日，NKGen Biotech宣布根据美国FDA批准的同情用药授权，向一名轻度阿尔茨海默病（AD）患者注射了首剂自体NK细胞产品troculeucel，该患者尽管正在接受Biogen/Eisai Leqembi（lecanemab/仑卡奈单抗）治疗，但认知能力仍持续下降。Troculeucel（研发代码：SNK01）是基于其超NK（SNK）平台开发的新型基于细胞的、患者特异性的体外扩增自体NK细胞免疫治疗药物。SNK将自身激活的NK细胞（自体SNK01）或供体NK细胞（SNK02）注入体内以改善免疫系统功能，消除患病或异常细胞并防止复发。使用从患者或捐献者血液中收获的高纯度NK细胞，活化并注入患者体内。同样因其来自患者血液，而不是转基因，并且与其他疗法（如CAR-T）相比，不良反应可能性更小。SNK在癌症、自身免疫和神经退行性疾病领域具有广泛的治疗潜力。NKGen 正在进行的双盲随机 2a 期临床试验 (NCT06189963) 专注于中期阿尔茨海默病，而此次单一IND标志着该公司首次拓展至轻度阿尔茨海默病的治疗领域，尤其针对对现有一线疗法无效的患者。2月份，NKGen Biotech公布TroculeucelAD 1期临床研究结果：90%患者获得稳定/改善结果，无药物相关不良事件。NKGen董事长兼首席执行官Paul Y. Song医学博士表示：“目前，FDA批准的两种针对淀粉样蛋白的疗法可用于治疗轻度认知障碍的阿尔茨海默病患者。虽然这两种疗法都被证明可以减缓认知衰退的速度，但它们并不能阻止病情进展或改善认知功能。根据我们迄今为止的临床经验，troculeucel耐受性良好，能够穿过血脑屏障，提高脑脊液（CSF）中淀粉样蛋白、α-突触核蛋白和tau蛋白的水平，同时还能减少神经炎症，其证据是胶质纤维酸性蛋白（GFAP）水平的降低。如果我们能够证明在接受标准淀粉样蛋白靶向疗法后病情持续进展的阿尔茨海默病患者中，其临床症状有所改善，这将为理解潜在的疾病机制提供重要见解，并可能为联合治疗策略的理论基础提供支持。”参考资料：公司公告

临床申请细胞疗法临床2期临床1期免疫疗法

100 项与 Troculeucel 相关的药物交易

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研发状态

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
阿尔茨海默症	临床2期	美国	NKGen Biotech, Inc.	2023-11-21
阿尔茨海默症	临床2期	加拿大	NKGen Biotech, Inc.	2023-11-21
转移性结直肠癌	临床2期	美国	NKGen Biotech, Inc.	2021-11-03
非小细胞肺癌	临床2期	美国	NKGen Biotech, Inc.	2021-11-03
局部晚期非小细胞肺癌	临床2期	美国	NKMAX Co., Ltd.	2021-07-08
转移性非小细胞肺癌	临床2期	美国	NKMAX Co., Ltd.	2021-07-08
晚期恶性实体瘤	临床2期	-	NKGen Biotech, Inc.	2021-03-01
膀胱癌	临床2期	-	NKGen Biotech, Inc.	2021-03-01
结直肠癌	临床2期	-	NKGen Biotech, Inc.	2021-03-01
EGFR阳性非小细胞肺癌	临床2期	-	NKGen Biotech, Inc.	2021-03-01

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临床结果

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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 (PipelineReview) 人工标引	临床1/2期	阿尔茨海默症	3	troculeucel	齋餘鹹製製齋積齋膚築(糧襯窪築艱遞築選簾艱) = None 衊夢網觸鹹築憲積膚齋 (窪觸蓋築壓積範憲網簾 ) 更多	积极	2025-04-07
NCT04678453 (GlobeNewswire) 人工标引	临床1期	阿尔茨海默症	11	Troculeucel	憲積繭鹹襯網夢觸蓋鏇(艱製憲夢鏇鬱築淵鹹積) = 90% of all evaluable subjects had either stable or improved (±0.1). 淵築膚淵餘廠憲網簾構 (艱製餘糧廠製憲餘襯繭 ) 更多	积极	2024-10-29
NCT06189963 (GlobeNewswire) 人工标引	临床1/2期	阿尔茨海默症	3	SNK01	鏇構鬱願繭艱艱遞糧願(積顧鑰膚憲遞憲齋選夢) = 鹽襯鏇鏇鹹顧網繭糧鬱範簾範遞蓋顧遞衊衊淵 (蓋醖鬱鏇鏇憲構遞淵膚 ) 更多	积极	2024-10-29
NCT04872634 (Pubmed \| J Immunother Cancer) 人工标引	临床1/2期	EGFR突变的非小细胞肺癌 EGFR Mutation	12	SNK01 + cytotoxic chemotherapycetuximab	醖鏇憲壓繭積構餘蓋獵(憲選簾窪獵鹽淵獵膚鬱) = 鹽觸艱齋壓廠鹽繭鑰膚網構醖艱構齋淵襯憲餘 (構餘願繭鹹築壓鏇鏇鬱 ) 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	網餘憲積選齋蓋糧製夢(糧構觸願鹽鏇壓醖鹹醖) = 淵憲鹹鬱繭醖構糧艱膚願繭窪鹹壓窪糧膚醖鑰 (鏇製製鏇淵膚鬱築構醖 ) 更多	积极	2024-03-25
NCT04678453 (Corporate Publications) 人工标引	临床1期	阿尔茨海默症	10	SNK01	鏇壓蓋築鬱積獵繭積構(獵遞鑰廠獵構艱襯齋鑰) = 膚襯齋糧糧構顧衊鹹顧築顧艱網鏇顧簾鏇鹹願 (壓夢觸餘選積鹽襯艱醖 ) 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	顧構網淵衊廠獵鹹簾觸(淵繭遞獵蓋選簾獵醖窪) = 齋願遞願鬱鑰鹹齋襯築築餘淵鏇夢壓築簾範築 (醖選遞淵淵廠鬱簾鹽觸 )	积极	2023-08-03
ESMO2022	N/A	肉瘤	8	SNK01 + Pembrolizumab	衊艱築膚艱衊遞鹽壓壓(憲艱壓憲齋壓繭繭鬱衊) = 艱鹹構餘範鏇淵繭憲製繭鏇製醖鑰觸網願壓願 (衊簾願襯簾鏇壓範膚構 )	-	2022-09-10
WCLC2022	临床1/2期	非小细胞肺癌	20	Pembrolizumab + SNK01 (2 x 10^9 cells/dose)	築築範製觸廠鏇網觸繭(衊觸鑰鏇襯獵鹹積淵淵): 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	蓋憲構積選簾淵製願顧(觸鑰憲構築網窪網齋鹽) = 範積鏇觸廠糧鹽鏇壓簾壓壓廠鏇繭鑰衊齋範鹹 (獵糧艱憲夢襯鏇淵網淵 ) 更多	积极	2022-06-02