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]

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: 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 ; Kim, Eo Jin ; Jung, Jae Seob ; 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.

107

项与 Troculeucel 相关的新闻（医药）

2025-02-22

·PipelineReview

NKGen Biotech Announces Administration of First Dose of Troculeucel to Frontotemporal Dementia Patient Under FDA-Cleared Compassionate Use Program

NKGen takes a meaningful step towards potential treatment for frontotemporal dementia (“FTD”) patients with limited treatment options. SANTA ANA, CA, USA I February 21, 2025 I NKGen Biotech, Inc. (Nasdaq: 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, today announced the administration of troculeucel, an expanded autologous NK cell therapy, in an FTD patient under a single compassionate use, Investigational New Drug (“IND”) cleared by the U.S. Food and Drug Administration (“FDA”). It is estimated that about 60,000 people in the U.S. are currently living with FTD. Up to 40% of FTD cases have a genetic component and the patient receiving troculeucel is known to carry the C9orf72 gene mutation. Currently, there is no cure for FTD and, unfortunately, no current treatments are available that slow or stop disease progression. NKGen has begun to explore the potential therapeutic role of troculeucel for the treatment of FTD in collaboration with Mario Mendez, M.D., Ph.D., Director of the Behavioral Neurology Program at the David Geffen School of Medicine at UCLA and Jessica Rexach, M.D., Ph.D., Director of the Rexach Lab at UCLA Department of Neurology. This single, FDA-cleared, IND compassionate use will be the initial step towards a future full IND application as the dosing of the first FTD patient is part of NKGen’s ongoing effort to explore the potential of its NK cell therapy for those suffering from neurodegenerative diseases, especially when existing therapies have not been effective. “While most of our experience has been in treating patients with Alzheimer’s and Parkinson’s, we know that there is a common theme of neuroinflammation and damage in numerous neurodegenerative diseases,” said Paul Y. Song, M.D., Executive Chairman and Chief Executive Officer of NKGen. “We have previously shown that troculeucel can cross the blood brain barrier to improve levels of amyloid, α-synuclein, and tau proteins in CSF in our treated Alzheimer’s patients as well as reduce neuroinflammation as shown by a reduction in glial fibrillary acidic protein (“GFAP”). Of note is that GFAP and tau are both consistently elevated in patients with FTD and we believe this supports the rationale of trying troculeucel in such patients. We are excited with the potential outcomes using our NK cell therapy in a difficult-to-treat patient population.” “The potential to influence brain disease by modulating peripheral immune components represents a truly pivotal frontier in our field,” said Dr. Rexach, M.D., Ph.D., Director of the Rexach Lab at UCLA Department of Neurology. “It’s imperative that we bring these opportunities forward to address additional devastating, currently incurable neurodegenerative disorders, like frontotemporal dementia, in addition to Alzheimer’s disease. By incorporating key biomarkers of both neuroinflammation and neurodegeneration, this work is designed to yield impact and achieve critical progress. This effort will ultimately inform effective strategies for immune cell modulation in FTD, paving the way for clinically effective strategies. This work is not only incredibly important, but also exceptionally timely.” “FTD and its related disorders are devastating for patients and families. As a clinician caring for them, it is difficult to tell them that there are no disease-modifying treatments,” said Dr. Mendez, M.D., Ph.D., Director of the Behavioral Neurology Program at the David Geffen School of Medicine at UCLA. “I’m impressed with the preliminary troculeucel clinical and biomarker data in Alzheimer’s patients and believe its ability to reduce both tau proteins and neuroinflammation in the cerebral spinal fluid (“CSF”) might be beneficial in FTD and related disorders. I look forward to exploring this further in hopes of making a real difference in these disorders.” The patient will be routinely assessed independently by Dr. Mendez at UCLA while receiving troculeucel infusions at the Sarcoma Oncology Center under the guidance of Dr. Sant Chawla and Dr. Erlinda Gordon. 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 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 . SOURCE: NKGen Biotech

细胞疗法免疫疗法临床研究临床申请

2025-02-18

·今日头条

当我问deepseek：肺癌患者手术后如何预防复发？这个回答太惊艳了

"手术很成功，但我的身体里还埋着定时炸弹。"即便是早期肿瘤，最好的外科专家做了根治切除，也有可能复发。这是全球4700万肺癌幸存者的致命问题。当我们把这一棘手问题抛给目前爆火的deepseek时，他给出了让人惊艳的建议，值得病友们收藏！据统计，手术切除后， 30%-75%的肺癌患者会发生复发，其中包括大约15%的I期肺癌患者。多数复发性肿瘤发生在远处病灶，且超过 80%的复发性肺癌发生在切除后的前两年内【1】。那么肺癌病友们应该注意哪些复发的早期症状，又应该在治疗后做哪些事情预防癌症卷土重来呢？癌细胞“复活”之谜：干细胞休眠+免疫瘫痪目前手术、放化疗均无法完全清除体内的癌细胞，此外还有研究证实癌干细胞似乎能够“隐藏”很长时间的能力，为癌症复发埋下“种子”。 ▶两大致命机制 1.癌症干细胞休眠：0.01%的癌细胞可潜伏10年以上，免疫系统无法识别； 2.免疫微环境抑制：术后残留癌细胞释放PD-L1蛋白，使T细胞"瘫痪"。 ▶ 三重高危因素 1.持续吸烟：复发风险激增7倍； 2.治疗残留：切缘阳性患者复发率高达90%； 3.基因突变：EGFR/ALK阴性患者更易转移。复发是很多肺癌患者抗癌失败的重要原因，因此不管是早期还是晚期肿瘤患者，手术及化疗后千万不可掉以轻心。当出现以下症状时，请一定要警惕：肺癌复发的6个征兆原有的症状与体征又出现（比如，肿瘤原来的部位出现新的肿瘤）; 体重明显下降; 极度疲劳；原有的异常标经治疗已恢复正常后又重新异常，如：肿瘤标志物正常后又升高; 淋巴结肿大或任何部位新发现占位性病变; 不同部位复发转移出现相应部位的症状与体征： 2025年四大预防复发利器开启“超长待机” 近年来，癌症疫苗，细胞免疫等新型免疫疗法在肺癌领域取得了重大突破，也为肺癌患者开启了全新的长生存希望！ 01 NK细胞免疫细胞中重要成员之一—NK细胞。医学上，NK细胞在对抗癌症的第一道防线中扮演关键角色。NK细胞有两方面抗癌作用，一是上述的对肿瘤细胞的直接杀伤，通过释放后穿孔素和颗粒酶或通过死亡受体杀死肿瘤细胞；二是它通过分泌细胞因子和趋化因子扮演免疫系统的调节细胞角色，激活T细胞等的杀伤作用。这些特点使NK细胞能在肿瘤免疫治疗中大有可为，国内和国际上都正在进行大量临床研究。 1、客观缓解率翻倍！NK联合PD-1成为阻击非小细胞肺癌的王炸组合国内一项发表在国际顶级期刊《The Journal of Clinical Investigation》上的NK细胞联合PD-1研究结果表明，NK细胞联合PD-1的客观缓解率（ORR）为36.5%，明显优于PD-1单药治疗的18.5%。这表明，派姆单抗联合NK细胞疗法的治疗效果是单纯采用派姆单抗治疗近1倍，并且联合治疗组的总生存期和无进展生存期显著延长。原文链接：免疫王炸组合！国内首个NK细胞联合PD-1治疗非小细胞肺癌数据出炉！ 2、58.3%肺癌患者生存期超2年，NK细胞向肺癌宣战！ SNK01是一种新型的自体NK细胞疗法，具有更强的抗癌效果，已发现对几类肺癌细胞系具有杀伤作用。 2022年世界肺癌大会公布的结果显示：SNK01联合PD-1治疗组患者的中位无进展生存期（PFS）为 6.2 个月，而PD-1单药治疗仅为 1.7 个月。证明组合疗法显著增强了免疫治疗的抗肿瘤活性。此外，2年的长期随访结果显示，联合治疗组生存率为 58.3% ，PD-1单药组为16.7%，显著增加了患者的长生存几率。原文链接：人体内的广谱抗癌“杀手”--NK细胞向肺癌宣战！联合PD-1效果倍增！ 3、NK细胞联合贝伐单抗成功缩小肿瘤晚期肺癌患者接受6个疗程的自体NK细胞群输注，每3周一次，其间接受吉西他滨加阿瓦斯汀联合治疗。结果显示：干咳、胸痛症状消失，饮食好转，生活质量明显改善，原发肿瘤较联合治疗前明显减小近一半。此外，本片未见纵隔淋巴结及两侧锁骨上淋巴结，这意味着转移灶已全部消失！回输6次肿瘤显著缩小！NK细胞联合贝伐单抗治疗成功晚期非小细胞肺癌 02 树突细胞（DC）树突细胞是目前所知的机体内功能最强的抗原提呈细胞，最大的特点是能够刺激初始T细胞进行增殖。因此，DC是机体免疫应答的始动者，在免疫应答的诱导中具有独特的地位。树突细胞在体内充分激活T细胞，促进T细胞对肿瘤的清除，树突细胞还能促进T细胞富集，增强对T细胞激活。目前，树突细胞疫苗在肺癌中取得了卓越的临床数据： 1.肺癌树突疫苗DCVAC/LuCa DCVAC/LuCa是由美国一家叫做SOTIO的生物公司研发的针对非小细胞肺癌患者的树突状细胞疫苗。通过将树突状细胞与裂解死亡后的患者自体肺癌细胞所释放的抗原物质融合，使树突状细胞获得识别肺癌细胞的能力，并经过体外扩增后回输入患者体内进行治疗。这款美国的前瞻疗法目前已经在国内知名的癌症中心-上海市胸科医院进行了 II 期临床研究，近期刚刚公布的数据证实，这种疗法已经在提高患者生存率方面显示出协同作用和显着潜力。总缓解率大幅提升！树突细胞疫苗联合化疗一线治疗晚期非小细胞肺癌初现曙光 2. 树突状细胞疫苗联合靶向治疗打开长生存大门 63 岁的M女士确诊为肺腺癌（IIIb 期：T2aN3M0），接受厄洛替尼联合树突细胞治疗，经过 321 天的联合治疗后，影像检查竟然已经看不到肿瘤了。而且，在治疗开始后至少 587 天内，肿瘤消失的状态持续存在，没有任何复发或转移的迹象，治疗时间超过了 699 天。 03 癌症疫苗 1.AI定制疫苗：48小时生产个体化抗癌导弹近期，甲骨文联合OpenAI启动"星际之门"计划，甲骨文（ORCL）董事长拉里・埃里森（LarryEllison）称：“人工智能有望通过早期癌症检测以及定制mRNA疫苗，彻底变革医疗保健领域”。埃里森表示，借助人工智能，仅需48小时就能生产出基于信使核糖核酸（mRNA）的疫苗。目前，莫德纳（Moderna）正运用其mRNA技术，与默克公司（MRK）合作开发癌症疫苗 2.cimavax疫苗让更多肺癌患者迈进“临床治愈”大门！5年生存率23%vs0%！和靶向药物不同，肺癌疫苗CIMAvax-EGF是一种基于生物技术的疫苗，它治疗晚期肺癌是生物免疫治疗的方式：它有助于身体产生自己的免疫系统，从而遏制癌症并阻止其增长，因此，基因检测没有突变的患者也能获益！ 5年生存率：EGF浓度高的患者接种疫苗后，生存获益更大。根据最新公布的数据，肺鳞癌患者五年生存率分别为23% VS 0%，肺腺癌为为18.2%VS0%！对照组没有患者活过5年。让晚期肺癌患者生存期超5年，这4款癌症疫苗成功“续命”！ 04 γδ-T细胞 γδ-T细胞在感染免疫、肿瘤免疫、AID等领域中所起的作用越来越受到广泛关注。国内外学者就其作用特点与机制做了大量研究，发现γδT细胞能执行复杂的功能，如免疫监视、免疫调节和发挥免疫效应等作用。特别是γδ-T 细胞可用于异体治疗的特质及其在实体瘤治疗中展现出卓越的潜力！中国暨南大学生物医学转化研究院研究团队对8例晚期肝癌和10例晚期肺癌患者(接受细胞治疗次数均在5次或以上)进行了随访，从他们第一次输注异体γδ-T 细胞开始，目前这些患者的生存时间中位数为42.4个月(范围为30-50个月)！四位一体防复发体系--这样做90%患者超5年无癌要知道，残存的几个癌细胞也有可能再次无限增殖，最终出现数百万个癌细胞共同形成一个肿瘤，这些病灶在初期极难被目前的检测手段发现。一旦出现复发转移，将岌岌可危。deepseek给出了四位一体的防复发体系： 01 查--液态活检时代开启一般来讲，术后第一年，每三个月复查一次；第二年，每半年复查一次，循环复查持续。需要注意的是，当肿瘤小于0.5cm时，传统的CT检查很难观察到，因此，一旦发现确切的病灶，往往为时已晚，肿瘤已经完全苏醒复发，甚至播散至全身！血液检查的发展（如ctDNA、cfDNA），使得我们能够提前对复发的风险进行预测。 ctDNA监测：可提前6-12个月预警复发 MRD检测：术后阳性患者接受强化治疗，复发风险降低72% 通过对循环血里面肿瘤细胞、肿瘤碎片（甚至是DNA水平的肿瘤碎片）的检测，获取肿瘤复发的信号。这对于早、中期肺癌术后复发风险的预测，具有非常大的帮助。（手术后的患者如果想密切监测血液中的循环肿瘤细胞水平，可以提交病历至全球肿瘤医生网医学部） 02 治--精准辅助治疗矩阵术前进行新辅助治疗，术后进行规范的辅助治疗（化疗、放疗、内分泌治疗及靶向治疗等），除此之外还有一些新获批和在研的辅助治疗技术能够帮助预防复发，如电场疗法、癌症疫苗等。再加上免疫，饮食，运动调节均能最大限度降低癌症复发转移风险。如： 2021年10月16日，FDA批准了阿替利珠单抗(Atezolizumab，Tecentriq)用于辅助治疗切除术及铂类辅助化疗后的Ⅱ至ⅢA期非小细胞肺癌患者（PD-L1≥1%）。将患者疾病复发或死亡的风险降低34% 。 03 调--免疫重建三重奏肺癌患者的免疫功能本身处于失常状态，而手术，放疗，化疗会对人体的免疫功能造成一定损伤，在临床治疗后，尽快调整免疫功能是预防复发转移的重中之重。对于免疫功能低下或异常的患者，临床医生会建议注射胸腺肽类的药物、干扰素，恢复免疫试别功能和恢复免疫杀伤功能的细胞免疫回输等等。免疫调节剂免疫调节剂属于非特异性免疫疗法，有助于免疫系统对抗细菌，病毒及癌细胞，包括胸腺肽，干扰素及白细胞介素等。需要提升免疫的人群会注射免疫调节剂，比如在赴前线抗击疫情的医护人员都注射了胸腺肽来提升免疫力；临床医生会放化疗之后同时给予胸腺肽或干扰素，白细胞介素等免疫调节剂来增强癌症患者的免疫力。胸腺肽是临床最常用的提升免疫的调节剂之一。过继性细胞调节过继性免疫细胞治疗技术是通过采集人体自身免疫细胞，经过体外培养，使其数量扩增成千倍增多，靶向性杀伤功能增强，然后再回输到患者体内，从而来杀灭血液及组织中的病原体、癌细胞、突变的细胞。如免疫细胞NK，DC,T细胞的临床辅助治疗已经过了大量的临床研究。肠道菌群调节越来越多的证据表明，癌症疗法会干扰机体的免疫反应，并导致免疫系统功能异常，进而影响化疗，放疗，靶向治疗，免疫疗法的效率。近年的重磅研究表明，肠道微生物可通过调节药物疗效，消除抗癌作用并介导毒性作用在癌症治疗中发挥重要作用。原文链接：显著提升PD-1、CAR-T治疗效果，肠道菌群有望成为癌症治疗的全能“黑马”！ 04 养--抗癌饮食密码此外，大家也最想知道吃什么能提高免疫，是不是多吃人参，虫草，海参就能提高免疫？这个问题其实没有答案，医生要么无法回答，要么每次都告诉你，要平衡膳食，营养均衡。事实上也确实如此，饮食均衡才是保证身体各项机能正常，特别是维持免疫力的基础。总体的原则是：各种蔬菜——深绿色、红色和橙色蔬菜、富含纤维的豆类（豆类和豌豆）等；水果，尤其是各种颜色的完整水果；全谷物类。限制以下食物红肉和加工肉类；含糖饮料；高度加工食品和精制谷物产品。综合治疗，开启无癌生存大门正如一位癌症病友就自己的亲身感受所说：“在癌症面前，谁能树起必胜的信念，遵循科学的防治原则，与经治医生密切配合，努力适应新环境，对周围事物培养兴趣和爱好，坚韧不拔地与病魔抗争，谁就能获得生存与康复的希望”。此外需要提醒大家的是，现在医学界更提倡通过多种治疗手段进行综合治疗，包括局部放化疗、靶向和免疫等，需要针对患者的具体情况综合考虑，量身定制。希望大家都能找到适合自己的抗癌方式，早日康复！参考文献：【1】https://www.verywellhealth.com/lung-cancer-recurrence-treatment-and-prognosis-2249264 【2】https://link-springer-com.libproxy1.nus.edu.sg/article/10.1007/s12026-017-8927-x 本文为全球肿瘤医生网原创，未经授权严禁转载

免疫疗法临床研究细胞疗法疫苗

2025-02-16

·药明康德

使100%患者保持完全缓解的T细胞疗法；使90%阿尔茨海默病患者认知功能稳定或改善的NK细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. γδ T细胞疗法INB-100用于造血干细胞移植后的白血病患者的1期临床试验数据亮眼，中位随访时间为20.1个月时，100%的急性髓系白血病（AML）患者仍保持完全缓解（CR）状态，其中有几名患者的缓解时间已超过3年。 2. 同种异体CAR-T疗法cemacabtagene ansegedleucel在一项针对复发/难治性大B细胞淋巴瘤（R/R LBCL）的1期临床试验中，在低疾病负荷患者中的CR率达100%。 3. 自然杀伤（NK）细胞疗法troculeucel用于治疗阿尔茨海默病，在一项1期临床试验中使90%患者的认知功能稳定或有所改善。药明康德内容团队整理 INB-100：公布1期临床试验的新数据 IN8bio公司公布了其在研现货型γδ T细胞疗法INB-100用于造血干细胞移植后的白血病患者的1期临床试验数据。INB-100是一款来自健康供体的同种异体γδ T细胞，在体外经过扩增和激活后，被输注到白血病患者体内。截至2025年1月17日的数据，中位随访时间为20.1个月，接受INB-100治疗的原始队列和扩展队列中，所有（100%）AML患者仍保持CR状态，其中有几名患者的缓解时间已超过3年。此外，与真实世界的历史数据相比，接受INB-100治疗的患者相比于接受标准治疗的患者展现出显著更高的一年无进展生存率和总生存率。即使是接受低强度预处理（RIC）的老年高危患者，INB-100也显示出显著的疗效。安全性方面，未报告细胞因子释放综合征（CRS）或神经毒性，移植物抗宿主病（GvHD）可控，感染轻微，对患者的生活质量无明显影响。 Cemacabtagene ansegedleucel（ALLO-501/A）：公布1期临床试验的新数据 Allogene Therapeutics公司宣布，其在研同种异体CAR-T疗法cemacabtagene ansegedleucel（cema-cel，以前称为ALLO-501/A）用于治疗R/R LBCL的1期临床试验数据已发表在Journal of Clinical Oncology期刊上。Cema-cel是一种经基因工程改造、靶向CD19的AlloCAR-T产品。Cema-cel通过TALEN基因编辑技术破坏TRAC与CD52基因，以减少产生GvHD的风险。此前，美国FDA授予cema-cel再生医学先进疗法（RMAT）认定，用于治疗R/R LBCL。数据显示，cema-cel的疗效与已批准的自体CD19靶向CAR-T细胞疗法相当：该研究中的总缓解率（ORR）和CR率分别为58%和42%，其中所选定用于关键2期试验的方案获得了最高的ORR和CR，分别为67%和58%。在达到CR的患者中，中位缓解持续时间（DOR）为23.1个月，中位总生存期（OS）尚未达到。此外，cema-cel的安全性可控，且与已批准的自体CD19靶向CAR-T细胞疗法一致。值得注意的是，cema-cel治疗在低疾病负荷患者中的CR率达100%。该结果为cema-cel作为LBCL患者的一线巩固治疗提供了支持，相关关键性2期试验ALPHA3已于2024年6月启动。 Troculeucel（SNK01）：公布1期临床试验数据 NKGen Biotech公司公布了其自体增强型自然杀伤（NK）细胞疗法troculeucel（SNK01）用于治疗阿尔茨海默病的1期临床试验数据。Troculeucel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患者脑脊液（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。此次公布的结果显示，10名可评估患者中，90%患者的认知功能稳定或有所改善。此外，troculeucel疗法耐受性良好，并对脑脊液中的蛋白质聚集体水平和神经炎症生物标志物产生了有益影响，其中pTau181和胶质纤维酸性蛋白（GFAP）的减少似乎与剂量相关。 INO-3107：公布1/2期临床试验数据 INOVIO公司宣布，其候选DNA疗法INO-3107的1/2期临床试验数据已发表于学术期刊Nature Communications。INO-3107正在被开发用于治疗成人HPV 6和HPV 11相关的复发性呼吸道乳头状瘤病（RRP），旨在引发针对HPV 6和HPV 11的靶向T细胞反应，以杀死受感染的细胞，使乳头状瘤消退。该疗法还可能清除或降低病毒水平，从而防止或减缓新乳头状瘤的生长。数据显示，与前一年相比，使用INO-3107治疗的32名受试者中，有26名（81.3%）手术干预次数降低，其中9名（28.1%）受试者在试验期间无需手术干预，ORR为72%。此外，INO-3107具有良好的耐受性和免疫原性，未报告＞2级的治疗相关不良事件。2020年，FDA授予INO-3107孤儿药资格，用于治疗RRP。该公司计划在2025年年中提交INO-3107的生物制品许可申请（BLA）。 Mevrometostat：公布1期联合治疗试验数据辉瑞（Pfizer）公布了其开发的EZH2抑制剂mevrometostat与雄激素受体抑制剂Xtandi（enzalutamide）联用，治疗转移性去势抵抗性前列腺癌（mCRPC）患者的1期临床试验的首个随机无进展生存期（PFS）结果。Mevrometostat是一款选择性、口服强效EZH2抑制剂。EZH2是基因转录的重要调控因子，在前列腺癌中与癌细胞增殖相关。在临床前模型中，mevrometostat与enzalutamide表现出协同作用，能够进一步抑制前列腺癌细胞系的增殖。截至2024年9月2日的数据，中位随访时间为9.6个月，mevrometostat加enzalutamide组患者的中位放射学PFS为14.3个月（7.5个月，不可评估），enzalutamide组患者在此数值上为6.2个月（4.1个月，13.9个月）。Mevrometostat/enzalutamide组合与enzalutamide相比，将疾病进展或死亡风险降低49%（HR=0.51，90% CI：0.28，0.95）。此外，在基线时携带可评估病灶的患者中，mevrometostat/enzalutamide组合组的总缓解率为26.7%，enzalutamide单药组这一数值为15.4%。 Tuspetinib：公布1/2期临床试验数据 Aptose Biosciences公司公布了1/2期TUSCANY试验的初步结果，该试验评估了FLT3抑制剂tuspentinib与venetoclax和azacitidine联用治疗新确诊的AML患者的效果。结果显示，3例FLT3野生型患者完成了第1个周期的治疗，无剂量限制性毒性（DLT）且无剂量调整。有两名患者在第1个治疗周期结束时达到CR加部分血液学恢复的完全缓解（CRh）。值得注意的是，其中有1例是具有双等位基因TP53突变和复杂核型的患者。第3名患者在第1个治疗周期内骨髓白血病细胞显著减少，并继续接受第2个周期的治疗。 IVW-1001：公布1/2期临床试验数据 IVIEW Therapeutics公司公布了其创新疗法IVW-1001用于治疗干眼症的1/2期临床试验数据。IVW-1001是一款含有TRPM8激动剂的眼部湿巾。此次公布的结果显示，IVW-1001在第4周时对干眼症患者的体征和症状产生了具有统计学和临床意义的改善，包括角膜荧光素染色的减少和眼干评分的显著降低。此外，泪液分泌量也有积极变化。研究还显示出剂量与效果间的关系，较高剂量（0.2%）在多个疗效终点上表现更优。安全性方面，IVW-1001在所有治疗组中均表现出良好的耐受性，大多数不良事件为轻度或中度。 THB335：公布1期临床试验数据 Third Harmonic Bio公司公布了其强效、选择性口服小分子KIT抑制剂THB335在健康受试者中的1期临床试验结果。结果显示，THB335具有约40小时的半衰期，支持每日一次给药，并在多个剂量水平下显示出剂量依赖性的药物暴露增加。这些数据支持THB335进入针对慢性自发性荨麻疹的2期临床试验。 ▲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] IN8bio Reports Updated Positive Results from Phase 1 Trial of INB-100 in Leukemia Patients. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/11/3024098/0/en/IN8bio-Reports-Updated-Positive-Results-from-Phase-1-Trial-of-INB-100-in-Leukemia-Patients.html [2] Bio-Path Holdings Provides Update from Phase 1/1b Clinical Trial of BP1002 for Treatment of Refractory/Relapsed Acute Myeloid Leukemia. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/12/3025403/0/en/Bio-Path-Holdings-Provides-Update-from-Phase-1-1b-Clinical-Trial-of-BP1002-for-Treatment-of-Refractory-Relapsed-Acute-Myeloid-Leukemia.html [3] Clinical and Immunological Results from Phase 1/2 Study of INO-3107 as a Treatment for Recurrent Respiratory Papillomatosis Published in Nature Communications. Retrieved February 14, 2025, from https://www.prnewswire.com/news-releases/clinical-and-immunological-results-from-phase-12-study-of-ino-3107-as-a-treatment-for-recurrent-respiratory-papillomatosis-published-in-nature-communications-302374685.html [4] Allogene Therapeutics Announces Publication of Durable Response Data from Phase 1 ALPHA/ALPHA2 Trials of the Allogeneic CAR T Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma in the Journal of Clinical Oncology. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/13/3026325/0/en/Allogene-Therapeutics-Announces-Publication-of-Durable-Response-Data-from-Phase-1-ALPHA-ALPHA2-Trials-of-the-Allogeneic-CAR-T-Cemacabtagene-Ansegedleucel-ALLO-501-in-Relapsed-Refra.html [5] NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer’s Disease. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/13/3025843/0/en/NKGen-Biotech-Announces-Publication-of-Phase-1-Troculeucel-Clinical-Trial-Results-for-the-Treatment-of-Alzheimer-s-Disease.html [6] IVIEW Therapeutics Announces Topline Results from Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe for Dry Eye Disease. Retrieved February 14, 2025, from https://www.prnewswire.com/news-releases/iview-therapeutics-announces-topline-results-from-phase-12-trial-of-ivw-1001-ophthalmic-eyelid-wipe-for-dry-eye-disease-302371387.html [7] Aptose’s Frontline Triple Drug Therapy with Tuspetinib Achieves Notable Responses in Newly Diagnosed AML Patients in the Phase 1/2 TUSCANY Trial. Retrieved February 14, 2025, from https://www.aptose.com/news-media/press-releases/detail/308/aptoses-frontline-triple-drug-therapy-with-tuspetinib [8] Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. Retrieved February 11, 2025, from https://meetings.asco.org/abstracts-presentations/243221 [9] Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium. Retrieved February 11, 2025, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-showcase-advancements-across-genitourinary-cancers [10] Oncology Innovation Day. Retrieved February 11, 2025, from https://s28.q4cdn.com/781576035/files/doc_downloads/2024/02/29/Pfizer-Oncology-Innovation-Day-Presentation_FINAL.pdf [11] Third Harmonic Bio Announces Phase 1 Clinical Results for THB335 and Provides Corporate Strategic Update. Retrieved February 14, 2025, from https://www.globenewswire.com/news-release/2025/02/11/3024041/0/en/Third-Harmonic-Bio-Announces-Phase-1-Clinical-Results-for-THB335-and-Provides-Corporate-Strategic-Update.html 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

细胞疗法临床1期临床2期免疫疗法临床结果

100 项与 Troculeucel 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
阿尔茨海默症	临床2期	美国	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	韩国	NKMAX Co., Ltd.	2021-07-08
晚期恶性实体瘤	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
膀胱癌	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
子宫内膜癌	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

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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


NCT06189963 (GlobeNewswire) 人工标引	临床1/2期	阿尔茨海默症	3	SNK01	蓋顧鬱選壓網膚鑰網觸(憲鏇壓膚積簾膚壓膚憲) = 網鹽襯鹽構淵齋範簾觸壓糧鏇繭襯築餘鏇積齋 (獵觸鬱築積糧艱鬱鬱壓 ) 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	糧鏇遞夢壓蓋簾齋簾網(淵壓鏇憲鑰築糧膚鑰築) = 90% of all evaluable subjects had either stable or improved (±0.1). 夢壓築願遞鹹醖衊網鏇 (顧積鬱衊構顧窪鹹餘製 ) 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	餘積積鑰蓋窪鏇築醖壓(鹹構夢願鹹築艱網鑰獵) = 繭夢膚簾壓艱積廠網襯蓋醖遞構廠鏇壓蓋製觸 (膚選構蓋淵觸鹹繭鏇鹹 ) 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	範壓鏇餘簾艱觸積艱顧(衊衊醖糧齋積餘壓壓衊) = 繭醖遞窪餘獵築獵鏇獵壓餘醖鑰醖願鹽簾鹽膚 (淵積鏇艱構繭鹽構鹹襯 ) 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	觸觸遞蓋構範遞選鑰觸(觸糧願積繭獵壓鹽範襯) = 蓋鏇壓艱壓艱觸觸鏇範鏇築範淵構築構簾積顧 (繭鬱積廠蓋鑰觸願鑰糧 ) 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	廠夢蓋窪構襯遞夢壓蓋(艱衊築願衊繭艱蓋鑰衊) = 觸製鹹餘製餘繭衊遞膚淵廠鑰鹽鹹積餘壓艱窪 (鹽襯願製顧壓顧夢壓觸 )	积极	2023-08-03
ESMO2022	N/A	肉瘤	8	SNK01 + Pembrolizumab	窪淵蓋艱醖範膚衊築醖(構觸糧網鏇繭淵製簾窪) = 鬱鑰願鏇襯壓選顧獵鑰鹽簾鹹鬱繭襯餘夢鏇選 (網餘願齋齋鏇壓鹹窪淵 )	-	2022-09-10
WCLC2022	临床1/2期	非小细胞肺癌	20	Pembrolizumab + SNK01 (2 x 10^9 cells/dose)	選壓鏇憲積構鹹鬱壓廠(鏇網範憲網鏇網夢鏇願): 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	鹹廠鬱積範夢積鑰鑰觸(願願遞廠淵顧襯襯鑰顧) = 顧鹽製淵糧艱繭簾願獵鏇獵遞糧壓襯範積積鬱 (襯醖鏇蓋網簾鹹糧鏇鬱 ) 更多	积极	2022-06-02
NCT03941262 (ASCO2022)	临床1期	难治性软组织肉瘤	15	SNK01 + Avelumab	窪壓衊遞構糧鏇顧製膚(鏇鹹觸製顧積廠蓋襯構) = 窪憲積襯醖艱壓醖鹽衊糧顧鹹廠鬱蓋壓憲窪齋 (膚範獵糧鑰齋網積鑰窪 ) 更多	-	2022-06-02