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更新于：2025-10-11

Aldesleukin

阿地白介素

更新于：2025-10-11

概要

基本信息

药物类型

白细胞介素

别名

125-L-Serine-2-133-interleukin 2、IL-2 (Chiron)、Interleukin-2 (Chiron)

+ [12]

靶点

IL-2R

作用方式

激动剂、刺激剂

作用机制

IL-2R激动剂(白细胞介素-2受体复合体激动剂)、免疫刺激剂

治疗领域

肿瘤泌尿生殖系统疾病皮肤和肌肉骨骼疾病+ [8]

在研适应症

肾细胞癌复发性神经母细胞瘤HPV阳性的口咽鳞状细胞癌+ [33]

非在研适应症

获得性免疫缺陷综合征急性嗜碱性粒细胞白血病急性嗜酸细胞白血病+ [112]

原研机构

Chiron Corp.

在研机构

National Cancer Institute

Prometheus Biosciences, Inc.

Iovance Biotherapeutics, Inc.

+ [8]

非在研机构

Roger Williams Realty Corp.

City of Hope National Medical CenterJonsson Comprehensive Cancer Center

+ [17]

权益机构

Clinigen Ltd.

Novartis AG

Prometheus Biosciences, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1992-05-05),

肾细胞癌

最高研发阶段(中国)临床1期

特殊审评孤儿药 (美国)、孤儿药 (韩国)

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结构/序列

Sequence Code 720

来源: *****

关联

425

项与阿地白介素相关的临床试验

NCT05821686

/ Not yet recruiting临床1/2期IIT

Efficacy of Intralesional IL-2 for Resectable Triple Negative Breast Cancer

This study is a single arm, phase II pilot design. The study will evaluate the safety and efficacy of intralesional immunotherapy (e.g. IL-2) in early stage TNBC. The overall objective of the research study is to advance our knowledge of novel immunotherapies and routes of administration for the treatment of TNBC
HYPOTHESES: Neoadjuvant treatment of TNBC with intralesional IL-2 is safe and well tolerated and can produce a pathological response.
Aim 1: Examine the safety and possible efficacy of a novel neoadjuvant intralesional intervention (IL-2) for patients with early-stage TNBC.

开始日期2026-01-02

申办/合作机构

Nova Scotia Health Authority

NCT06904066

/ Recruiting临床1期IIT

A Phase I Study of Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Other Hematologic Malignancies

Background:
Blood cancers (such as leukemias) can be hard to treat, especially if they have mutations in the TP53 or RAS genes. These mutations can cause the cancer cells to create substances called neoepitopes. Researchers want to test a method of treating blood cancers by altering a person s T cells (a type of immune cell) to target neoepitopes.
Objective:
To test the use of neoepitope-specific T cells in people with blood cancers
Eligibility:
People aged 18 to 75 years with any of 9 blood cancers.
Design:
Participants will have a bone marrow biopsy: A sample of soft tissue will be removed from inside a pelvic bone. This is needed to confirm their diagnosis and the TP53 and RAS mutations in their cancer cells. They will also have a skin biopsy to look for these mutations in other tissue.
Participants will undergo apheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.
The T cells will be grown to become neoepitope-specific T cells.
Participants receive drugs for 3 days to prepare their body for the treatment. The modified T cells will be given through a tube inserted into a vein. Participants will need to remain in the clinic at least 7 days after treatment.
Participants will have 8 follow-up visits in the first year after treatment. They will have 6 more visits over the next 4 years. Long-term follow-up will go on for 10 more years.

开始日期2025-10-15

申办/合作机构

National Cancer Institute

NCT06626256

/ Not yet recruiting临床1期IIT

A Phase 1 Safety and Efficacy Study of STIL101 for Injection in Locally Advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Renal Cell Carcinoma, Cervical Cancer, and Melanoma

This phase I trial tests the safety and side effects of STIL101 for injection and how well it works in treating patients with pancreatic cancer, colorectal cancer (CRC), renal cell cancer (RCC), cervical cancer (CC) and melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). STIL101 for injection, an autologous (made from the patients own cells) cellular therapy, is made up of specialized white blood cells called lymphocytes or "T cells" collected from a piece of the patients tumor tissue. The T cells collected from the tumor are then grown in a laboratory to create STIL101 for injection. STIL101 for injection is then given to the patient where it may attack the tumor. Giving chemotherapy, such as cyclophosphamide and fludarabine, helps prepare the body to receive STIL101 for injection in a way that allows the T cells the best opportunity to attack the tumor. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes. Aldesleukin increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Giving STIL101 for injection may be safe, tolerable and/or effective in treating patients with locally advanced, metastatic or unresectable pancreatic cancer, CRC, RCC, CC and melanoma.

开始日期2025-10-05

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与阿地白介素相关的临床结果

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100 项与阿地白介素相关的转化医学

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100 项与阿地白介素相关的专利（医药）

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2,962

项与阿地白介素相关的文献（医药）

2025-12-01·PROTEIN EXPRESSION AND PURIFICATION

High-efficient refolding and purification of recombinant human interleukin-2 from inclusion bodies

Article

作者: Wang, Shanshan ; Zhang, Sheng ; Wang, Jiayu ; Fang, Yuming ; Zhao, Xinyi ; Wang, Fei ; Yu, Jiawei ; Wang, Shuo ; Jing, Xiaoran ; Jiang, Junjun ; Liu, Yuxiao

Human interleukin-2 (hIL-2) serves as a crucial cytokine in the treatment of cancer and autoimmune disorders. Nevertheless, the advancement of research and clinical applications involving this cytokine has been hindered by the constraints associated with the production of recombinant human interleukin-2 (rhIL-2). This study presents a scalable and robust purification protocol for rhIL-2 derived from inclusion bodies (IBs) in Escherichia coli. Our results indicate that microfiltration-based method could improve the purity of the denatured IBs effectively, and various refolding conditions were assessed to improve the recovery of refolded rhIL-2, resulting in an increase in the refolding yield from 15 % to 45 %. Subsequently, purification through three-column chromatography could refine the refolded rhIL-2 efficiently. Ultimately, the robustness of the purification process is substantiated by three consecutive scale-up experiments, achieving a productivity of 4 mg rhIL-2/g cell pellets, alongside high product purity and significant product activity.

2025-09-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Receptor-based bioassay for functional IL-2 quantification

Article

作者: Wang, Shanshan ; Shan, Xuelian ; Wang, Jiayu ; Gong, Grace ; Hu, Xinyue ; Xu, Shuangshuang ; Lu, Chuanwei ; Fang, Yuming

IL-2 is a potent cytokine that promotes multiple immune cells proliferation and activation. Accordingly, IL-2 based immunotherapies are emerging to treat cancers or AIDS by enhancing T cell growth and function. Besides, IL-2 is indispensable in in vitro cultivation of immune cells which is a critical step of CAR-T or CAR-NK immunotherapies. In bulk manufacturing of recombinant IL-2, E. coli expression system has several advantages such as low cost and rapid growth. However, high level protein expression in prokaryotic organisms often results in inactive insoluble aggregates, also known as inclusion bodies. It is crucial and most challenging work to solubilize and refold the protein of interest from inclusion bodies to generate its bioactive form. While multiple spectrum method had been applied to monitor the refolding process, the question of how to measure the refolding efficiency from the perspective of its biological function remained unaddressed. Here we present a receptor-based sandwich ELISA method to evaluate the bioactive product in samples and provide a guidance for manufacturing bioactive rhIL-2 (recombinant human IL-2) with prokaryotic expression system. Compared to traditional antibody-based ELISA method, this novel approach truly measures the presence of functional rhIL-2 and also potentially allows the detection of rhIL-2 variants with modifications like PEGylation as it doesn't rely on the exact amino acid sequence.

2025-07-01·CYTOKINE

The role of interleukin (IL)-2 cytokine family in Parkinson's disease

Review

作者: Tabari, Mohammad Amin Khazeei ; Daglia, Maria ; Amini, Alireza ; Larsen, Danaé S ; Sanaye, Pantea Majma ; Khan, Haroon ; Alsharif, Khalaf F ; Hadipour, Mahboube ; Goleij, Pouya

Parkinson's disease (PD) is a neurodegenerative disorder, which primarily impacts the nervous system, marked by its immune and inflammatory characteristics. The interleukin-2 (IL-2) cytokine family has a crucial role in regulating both neuroinflammation and immune activity, positioning it as one of the critical immune pathways in PD. Balancing pro-inflammatory and anti-inflammatory signals in PD heavily depends on the IL-2 cytokine family, that includes IL-2, IL-4, IL-7, IL-9, IL-15 and IL-21. This balance is vital for neuron survival and resistance to degeneration. Disruptions in IL-2 signaling can upset the equilibrium among regulatory T cells (Tregs) and pro-inflammatory T cells, such as Th1 and Th17, further aggravating the chronic neuroinflammation typical of PD. In PD, a decline in IL-2 or receptor dysfunction can hinder Treg activity, leading to increased inflammation and neurodegeneration. Similarly, IL-15 and IL-21 supports cytotoxic immune cell function, including natural killer (NK) cells and CD8+ T cells, which may exacerbate neuronal damage by sustaining pro-inflammatory processes. Moreover, IL-4 and IL-7 have anti-inflammatory roles in maintaining T cell homeostasis, and their dysregulation can contribute to interruption of the blood-brain barrier and increased infiltration of immune cells into the central nervous system. Targeting the IL-2 cytokine family in Parkinson's disease has shown therapeutic potential by expanding Tregs, which reduce neuroinflammation and promote dopaminergic neuron survival. Recombinant IL-2 and IL-2/anti-IL-2 complexes have demonstrated efficacy in animal models, enhancing Treg function and leading to improved neuroprotection. Additionally, IL-4-based therapies have been explored for their ability to shift microglia toward a neuroprotective phenotype, further enhancing neuronal survival by modulating inflammatory responses and cellular metabolism. Current research is exploring how to optimize cytokine delivery while minimizing immune side effects, with the goal of developing more targeted therapies for PD.

175

项与阿地白介素相关的新闻（医药）

2025-09-29

·今日头条

7年总生存率55.1%！四大免疫疗法，亮剑肺癌、肝癌、乳腺癌等

全球每年约1800万人确诊癌症。尽管筛查提升了符合条件人群的早期发现率，但仅25%–30%患者就诊时处于疾病局部阶段，可手术切除治愈。即便手术成功，复发常见，癌症转移更是患者死亡主因——世卫组织数据显示，超90%癌症相关死亡源于转移，这在一线治疗失败后尤为突出。过去十年，细胞免疫疗法已成为非小细胞肺癌（NSCLC）的变革性治疗策略。其通过体外修饰或扩增肿瘤浸润淋巴细胞（TIL）、嵌合抗原受体（CAR）T细胞、自然杀伤（NK）细胞等免疫效应细胞，产生高特异性、持久性抗肿瘤反应。其中：DC疫苗可增强免疫功能、安全性好，联合其他疗法效果更优；mRNA疫苗（尤其特定新抗原技术型）可引发强大抗肿瘤免疫反应；NK细胞疗法从简单输注发展为定制化形式，疗效与持久性显著提升。全球肿瘤医生网小编也希望下文的科普，让病友们多了解这些“救命的”前沿抗癌疗法，抗癌路上少走弯路，重燃生活希望！抗癌“新武器”已就位！细胞免疫疗法四大王牌，激活自身免疫力，让“精准抗癌”照进现实过去十年，细胞免疫疗法已成为癌症的变革性治疗策略，树突状细胞（DC）疫苗、mRNA疫苗、T细胞疗法、自然杀伤（NK）细胞疗法均具独特机制与临床潜力。 1、树突状细胞（DC）疫苗：利用DC强大的抗原呈递能力激发肿瘤特异性T细胞应答——作为专业抗原呈递细胞，DC能启动幼稚T细胞，引发针对癌症相关抗原的强适应性免疫应答。体外构建非小细胞肺癌（NSCLC）DC疫苗的常用方法为：分离患者自体单核细胞并转化为DC，加载黏蛋白1（MUC1）、维尔姆斯肿瘤1（WT1）或定制新抗原等肿瘤相关抗原（TAA）；加载抗原的DC成熟后回输患者，以触发靶向癌细胞的细胞毒性T淋巴细胞（CTL）应答（详见下图）。 ▼树突状细胞疫苗生产和作用机制图：从患者血液采集到肿瘤特异性 T 细胞活化 ▲图源“cells”，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 2、 mRNA癌症疫苗：已在多项早期试验中用于评估晚期非小细胞肺癌等癌种。多数患者可检测到新抗原特异性T细胞应答，生产可行性亦获验证；与免疫检查点抑制剂（ICI）联用可增强免疫原性与临床活性，且安全性良好。 3、自然杀伤（NK）细胞疗法：NK细胞（天然淋巴细胞）可通过死亡受体信号传导、穿孔素/颗粒酶释放及抗体依赖性细胞毒作用（ADCC），无需预先致敏肿瘤细胞即可将其清除。在NSCLC中，抑制性检查点上调、激活性配体下调，故需通过治疗增强NK活性。 4、肿瘤过继性T细胞疗法（ACT）：取患者自身或供者T淋巴细胞，经体外感应筛选或基因修饰获得肿瘤杀伤活性、扩增后回输患者，以发挥杀伤作用。目前其主要包括 CAR-T、TCR-T、TIL（肿瘤浸润淋巴细胞）疗法三类。 DC细胞疫苗联合T细胞疗法，改写肺癌预后不良困局，7年总生存率达55.1% 一项肺癌辅助化学免疫治疗III期随机对照试验的最终结果及免疫学分析证实：接受免疫治疗的患者具有显著优势。该研究纳入103例术后预后不良的晚期肺癌患者，将其随机分为两组：A组（化学免疫治疗组）接受自体活化杀伤性T细胞和树突状细胞（AKT-DC）过继移植联合治疗，B组（对照组）仅接受化疗，中位随访时间为59.6个月。结果显示：两组总生存率（OS）与无复发生存率（RFS）差异显著。 1、总生存率（OS）： A组（DC疫苗联合T细胞治疗组，AKT-DC）2年、5年、7年OS率分别为96.0% （95%CI：84.9–99.0）、 69.4% （范围：54.4–80.3）、 55.1% （范围：34.3–71.7）； B组分别为64.7% （范围：50.0–76.1）、 45.1% （范围：31.2–58.0）、 38.1% （范围：24.6–51.4）（详见下图）。 ▲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 2、无复发生存率（RFS）： A组2年、5年、7年RFS率分别为70.0% （95%CI：55.3–80.7）、 57.9% （范围：43.1–70.2）、 47.5% （范围：29.2–63.8）； B组分别为43.1% （范围：29.4–56.1）、 31.4% （范围：19.3–44.2）、 28.5% （范围：16.7–41.5）（详见下图）。 ▲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 ASCO重磅数据：零死亡+低复发！LK101疫苗力挫肝癌，1年复发率仅18.2% 2023年3月，我国自主研发的个性化肿瘤新抗原疫苗“LK101注射液”获国家药监局药品审评中心临床试验默示许可，用于晚期实体瘤治疗。作为我国mRNA肿瘤疫苗领域的里程碑产品，LK101是结合树突状细胞（DC）与mRNA双重优势的个性化新抗原靶向疫苗——依据患者数十种肿瘤突变信息，将编码个性化肿瘤抗原靶点的mRNA转导至DC细胞中，激活针对癌细胞的特异性免疫反应以实现攻击与清除，可作用于多款晚期实体瘤。 2024年美国临床肿瘤学会（ASCO）大会上，其治疗肝细胞癌（HCC）的首次人体临床研究（NCT03674073）公布亮眼数据，进一步佐证疗效。该研究纳入24例IIa期HCC患者，按1∶1随机分组：疫苗接种组接受LK101联合消融治疗，对照组仅接受消融治疗。结果显示：LK101联合消融疗法安全性可控，且存在免疫激活证据，更展现出显著的降复发与延生存潜力： 1年复发率分别为18.2%（疫苗接种组） vs 33.3%（对照组）；2年复发率分别为36.4%（疫苗接种组） vs 51.4%（对照组）。两组中位随访时间分别为48.4个月、38.8个月，对照组有3例患者死亡，而疫苗接种组12例患者均存活。这意味着，12名接受疫苗的患者生存期长达4年以上！ ▲截图源自“NMPA官网” HPV-TIL疗法让化疗难治性宫颈癌患者长期无癌，完全缓解≥15个月，最长无癌生存22个月转移性宫颈癌是化疗难治性上皮性恶性肿瘤，亟需新的治疗手段，而过继性T细胞疗法（ACT）正展现出广阔前景。《临床肿瘤学杂志》报道的一项研究显示：转移性宫颈癌患者接受针对HPV E6/E7反应性筛选的肿瘤浸润性T细胞（HPV-TIL）治疗后，实现了肿瘤客观消退，其中两例患者达成长期完全缓解。该研究共纳入9例转移性宫颈癌患者，中位年龄37岁（30-59岁），肿瘤类型涵盖鳞状细胞癌（4例）、腺癌（3例）、腺鳞癌（2例）；HPV血清型以HPV-18为主（7例），HPV-16占2例。所有患者均存在多处远处转移，且既往均接受过铂类化疗（部分联合放化疗）。入组后，患者先接受淋巴细胞耗竭化疗联合阿地白介素治疗，随后单次输注HPV-TIL。结果显示，9例患者中 3例实现客观缓解（ORR 33.3%）：2例达完全缓解（CR），缓解持续时间分别为22个月和15个月；1例达部分缓解（PR），缓解持续3个月。其中两例完全缓解患者的情况尤为值得关注：患者3（转移性鳞状细胞癌）：经顺铂+长春新碱+博来霉素诱导治疗、吉西他滨+顺铂放化疗、拓扑替康+紫杉醇等多线治疗后，HPV-TIL治疗前肿瘤已进展至主动脉旁、双侧肺门、隆突下及髂骨等部位（详见下图C）。治疗后所有病灶完全消退，22个月时仍无疾病迹象。 ▲图源“ASCO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除患者6（转移性腺癌）：原发肿瘤对放化疗无应答，经挽救性手术后病情仍持续进展，累及腹膜后淋巴结、肝脏表面等部位，伴右侧输尿管肾积水、双侧肺栓塞，需依赖输尿管支架及抗凝治疗。HPV-TIL治疗前，腹膜后、腹壁、结肠旁等多处肿瘤仍在进展。治疗后达成完全临床缓解，15个月时无疾病迹象，右侧输尿管支架已移除（详见下图D）。 ▲图源“ASCO”，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 NK细胞联手曲妥珠单抗，暴击耐药HER2阳性乳腺癌，从“无药可用”到“病情稳控” 《临床癌症研究》曾报道一项Ⅰ期临床研究，评估自体NK细胞联合曲妥珠单抗治疗HER2阳性乳腺癌的效果。该研究共纳入19例18~75岁、对标准治疗耐药的HER2阳性晚期乳腺癌患者，均接受上述联合治疗。结果显示： 6例患者达到病情稳定（SD），且缓解持续时间≥6个月（范围6~12个月）。值得一提的是，其中1例55岁的转移性激素受体阳性、HER2阳性乳腺癌患者实现了部分缓解（PR）：该患者既往已接受过抗HER2治疗、激素疗法及多种化疗，经连续2个周期联合治疗后达PR，并在第8周期治疗后仍维持这一状态（详见下图）。此外，其肿瘤标志物CA-153水平从治疗前的146.8，下降至治疗第5周期的75.4，治疗结束时仍稳定在76.6 。 ▲图源“AACR”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语癌症转移与复发虽均威胁生命，但转移因癌细胞恶性程度更高、治疗难度更大、对生存率影响更致命，总体预后比复发更差。不过，随着靶向治疗、免疫治疗、精准放疗等技术发展，部分转移患者也能实现长期生存。但全球肿瘤医生网小编也需提醒广大癌友，癌症作为一种极其狡猾并高度突变的疾病，其预防和治疗不是一蹴而就的。早发现、规范治疗和定期监测是核心；同时手术、放化疗在癌症治疗领域的地位不可撼动；在此基础上，患者可结合自身情况辅助癌症疫苗（如DC疫苗、mRNA癌症疫苗）、过继性T细胞疗法（CAR-T、TCR-T、TIL细胞疗法）等手段，降低癌症复发/转移风险、提高生活质量、尽可能延长生存期。参考资料 [1]Masroor Ali Beg M,et al.Advances in Non-Small Cell Lung Cancer Cellular Immunotherapy: A Progress in Dendritic Cell, T-Cell, and NK Cell Vaccines[J]. Cells, 2025, 14(18): 1453. https://www.mdpi.com/2073-4409/14/18/1453 [2]Kimura H,et al.Randomized controlled phase III trial of adjuvant chemoimmunotherapy with activated cytotoxic T cells and dendritic cells from regional lymph nodes of patients with lung cancer[J]. Cancer Immunology, Immunotherapy, 2018, 67(8): 1231-1238. https://link.springer.com/article/10.1007/s00262-018-2180-6 [3]Stevanović S,et al.Complete regression of metastatic cervical cancer after treatment with human papillomavirus–targeted tumor-infiltrating T cells[J]. Journal of Clinical Oncology, 2015, 33(14): 1543-1550. https://ascopubs.org/doi/10.1200/JCO.2014.58.9093 [4]Lee S C,et al.Phase I trial of expanded, activated autologous NK-cell infusions with trastuzumab in patients with HER2-positive cancers[J]. Clinical Cancer Research, 2020, 26(17): 4494-4502. https://aacrjournals.org/clincancerres/article/26/17/4494/82678/Phase-I-Trial-of-Expanded-Activated-Autologous-NK 本文为全球肿瘤医生网原创，未经授权严禁转载

免疫疗法疫苗细胞疗法信使RNA临床研究

2025-09-03

·今日头条

45%缓解率碾压全球竞品！六款国研TIL荣登2025国际峰会！

2025年第七届TIL峰会（7th Annual TIL Therapies Summit）将于11月11日-13日在美国波士顿西港海畔威斯汀酒店举行。作为聚焦肿瘤浸润淋巴细胞（TIL）疗法的国际顶级学术与产业盛会，它既是制药企业、学术专家等多方的专业交流平台，旨在推动实体瘤免疫治疗的技术突破与临床转化。自2024年2月16日，首款TIL细胞治疗药物获美国FDA批准上市以来，已确立恶性肿瘤临床治疗“变革者”地位，但在生产、规模化应用、风险控制及非黑色素瘤适应症拓展等方面仍存挑战。本届峰会将汇聚顶尖专家，分享临床前沿、开展解决方案导向研讨，重点攻坚三大方向：缩短周转时间、降低扩增对IL-2的依赖、扩大生产规模以惠及更多患者。值得关注的是，中国三家TIL领域代表性企业受邀参会，将汇报六款针对肝癌、肺癌、黑色素瘤、宫颈癌、卵巢癌、肠癌等等实体瘤的国产TIL疗法进展。以下，全球肿瘤医生网医学部将梳理会上重点国产产品信息，为癌友提供参考、增强信心。我们坚信，每一项突破都在拉近“癌症可治”的梦想，每一份坚持都将助力铸就生命奇迹！ 2025 TIL峰会前瞻：六款国研TIL秀黑科技，从“CRISPR编辑”到“无需清淋”，惠及肝癌、肺癌、黑色素瘤、宫颈癌、卵巢癌、肠癌等（一）BST02：百吉生物 BST02注射液是百吉生物（Biosyngen）基于MSE-TIL平台研发的过继性免疫细胞治疗产品，其有效成分为患者自身肿瘤浸润淋巴细胞，经体外富集、扩增后形成具有抗肿瘤活性的T细胞，拟用于肝细胞癌、胆管癌等所有类型肝癌的治疗。该疗法的作用原理为：从患者肿瘤组织中采集并富集肿瘤抗原特异性淋巴细胞，通过细胞因子诱导实现体外快速增殖并维持干性，最大限度扩增功能型抗肿瘤T细胞，再回输患者体内以杀伤肿瘤。与传统TIL药物相比，BST02突破了多项应用限制——通过低温保存解决了生产需靠近临床中心的距离难题，且无需使用高浓度白细胞介素-2（IL-2），降低了安全风险。 2023年10月，BST02获美国FDA批准进入I/II期临床试验；2024年1月，其又获中国国家药监局药品审评中心（CDE）批准，成为全球首个进入临床阶段的肝癌TIL疗法，也是目前唯一覆盖所有肝癌类型的TIL产品。探索性临床试验初步数据显示，低剂量组已完成入组与输注， 48天内部分缓解（PR）率达60% ，安全性与有效性均获验证。在“Biosyngen官微”公布的BST02的I期注册临床试验中，更是取得重大突破：一位晚期肝癌患者经“介入+靶向+免疫”一线治疗及二线治疗失败后，接受低剂量BST02回输。治疗6周后病灶缩小57.1%，18周时靶病灶完全消除（CR），癌栓显著缩小，目前无疾病进展生存时间（PFS）已达162天（约24周）；治疗期间未出现2级及以上细胞因子释放综合征（CRS）、免疫效应细胞相关神经毒性（ICANS）及其他严重不良反应。这也是全球TIL领域首次在肝癌治疗中实现临床完全缓解。在第七届TIL峰会上，百吉生物将分享TIL疗法的监管框架、数据可转换性完善路径，以及BST02肝癌项目的最新临床进展与中美两国申报监管经验。（二）GT101：沙砾生物 GT101是沙砾生物（Grit）研发的TIL产品，依托自体TIL过继细胞疗法技术，拟用于治疗转移性或复发性实体瘤。2022年4月22日，该产品注射液（受理号：CXSL2200061）获国家药监局药品审评中心（CDE）临床试验默示许可，成为国内首个获批临床的TIL药物，具有里程碑意义。 2025年ASCO大会上，沙砾生物公布了GT101针对11例复发性或转移性宫颈癌患者的I期临床试验（NCT05430373）数据。该11例患者中位年龄48岁，既往中位接受过2线治疗，均经标准FC方案淋巴细胞清除后接受GT101输注，随后给予高剂量IL-2治疗。结果显示：客观缓解率（ORR）达45.5% （5/11），疾病控制率高达90.9% （10/11）；其中 4例（36.4%）确认为部分缓解（PR）， 1例（9.1%）达完全缓解（CR），5例（45.5%）达病情稳定（SD）。中位无进展生存期（PFS）为4.83个月，中位总生存期（OS）尚未达到。值得关注的是，1例IIIC2期宫颈鳞状细胞癌患者在接受治疗后，基线71.57mm的病灶于28天后缩小至29.12mm，第12周影像学评估达CR，且缓解已维持14.5个月。综上，GT101在复发性和转移性宫颈癌患者中展现出临床意义明确的疗效与持久缓解效果，且无相关长期安全性问题。其45.5%的ORR显著优于全球同适应症已知竞品，显示出良好的长期生存潜力。（三）GT201：沙砾生物 GT201是沙砾生物研发的另一款TIL产品，其核心特征是在肿瘤浸润淋巴细胞（TIL）表面稳定表达膜结合IL-15，旨在增强TIL的持久性与功能、改善肿瘤微环境的免疫抑制状态，有望为晚期实体瘤患者带来持久疗效。 2024年ASCO大会上，沙砾生物公布了GT201临床研究（NCT05729399）的7例患者数据：该研究共入组7例患者，均为可评估疗效对象，涵盖非小细胞肺癌（NSCLC）、恶性黑色素瘤、宫颈癌、卵巢癌等适应症；患者中位年龄48岁，既往中位接受过3线治疗，其中1例有骨转移、2例有肝转移、1例有脑转移病史。治疗方案为：患者经标准FC方案淋巴细胞清除后，接受≥5×10⁹总活细胞剂量的GT201输注，其中5例后续加用IL-2。结果显示： 3例（42.9%）达到确认的部分缓解（PR），2例（28.6%）最佳疗效为病情稳定（SD）；尤其在NSCLC亚组中， 3例患者（100%）均实现疾病控制（定义为SD≥24周或任何PR），且所有患者体内均能检测到GT201细胞。综上，对于既往多线治疗失败的晚期/转移性实体瘤患者，FC清除后输注GT201联合后续高剂量IL-2的方案安全性可控；GT201在NSCLC中显示出良好疗效，客观缓解率与疗效持久性令人鼓舞，且未发生与GT201相关的≥3级不良反应。在2025年第七届TIL峰会上，沙砾生物将介绍GT201的产品设计思路，以及临床试验前10例实体瘤患者的最新数据——初步疗效已涵盖1例完全缓解（CR）、多例部分缓解（PR）病例。 TIL疗法临床案例分享 TIL疗法在肺癌治疗中的有效性此前已得到证实。作为全球首款获批上市的TIL疗法，Lifileucel（Amtagvi®）除已获批用于黑色素瘤治疗外，在肺癌治疗中亦展现出令人瞩目的效果。《癌症探索》杂志曾报道一则经典案例：一名41岁IV期粘液性肺腺癌男性患者，携带KRASG12D突变，肿瘤突变负荷（TMB）为3.3mut/Mb，PD-L1表达为0%。其接受TIL治疗前，CT显示治疗反应持续时间仅1.1+个月；而接受Lifileucel治疗6周后，治疗反应持续时间延长至26.2+个月，且疗效随时间推移逐渐加深，至输注12周时，部分缓解（PR）率高达81%（详见下图）。 ▲图源“Cancer Discov”，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）GT300：沙砾生物 GT300是沙砾生物依托天泽云泰AaCas12b Max技术平台开发的下一代基因编辑型TIL产品。该产品采用CRISPR/AaCas12b Max技术，敲除经全基因组CRISPR筛选确定的两个关键免疫调节靶点，旨在逆转TIL细胞耗竭、增强其功能，并克服抑制性肿瘤微环境（TME）。GT300具备编辑效率高、脱靶事件少的特点，拟用于卵巢癌、结直肠癌等冷肿瘤治疗。相较于传统SpCas9编辑的TIL产品，AaCas12b Max技术为GT300带来显著性能优势：大规模生产中，细胞扩增速率提升3-5倍，活力显著增强，且干细胞特性更优，能有效抑制耗竭与凋亡；体内实验显示，输注后的GT300仍保持优异扩增能力，印证该技术大幅降低了细胞遗传压力。这些特性使GT300兼具高效基因编辑能力、高安全性及出色的细胞存续与适应性能。目前，GT300的首次人体临床试验正在中国开展，旨在评估其在晚期实体瘤（主要为III期或IV期不可切除/转移性实体瘤）中的初步安全性与有效性。在第七届TIL峰会上，沙砾生物将汇报这款基于CRISPR/AaCas12b Max技术的GT300产品相关进展，让我们拭目以待！ TIL疗法临床案例分享 2024年美国临床肿瘤学会（ASCO）年会上，公布了我国首款无需清淋、也无需联合IL-2的TIL产品GC203，用于治疗复发性卵巢癌的Ⅰ期临床试验（NCT05468307）的振奋结果。其中1例卵巢子宫内膜样癌患者，经包括PARP抑制剂、化疗在内的五线治疗后病情仍持续进展，接受GC203输注后达到部分缓解（PR），阳性率66%，目标病灶缩小（详见下图）。 ▲图源“JUN CELL官网”，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（五）HS-IT101：华赛伯曼肿瘤浸润淋巴细胞过继细胞疗法（TIL-ACT）在多种实体瘤中展现出巨大治疗潜力，且已成为黑色素瘤的有效治疗手段，但治疗中高剂量淋巴细胞清除化疗与IL-2输注可能带来严重安全风险，甚至危及患者生命。为此，华赛伯曼研发了仅需低剂量淋巴细胞清除和IL-2输注的TIL细胞治疗产品HS-IT101，以降低风险、提高临床可及性。 HS-IT101是华赛伯曼开发的自体天然加强型TIL产品，其新药IND申请于2023年11月29日获国家药品监督管理局（NMPA）批准（受理号：CXSL2300599），用于治疗黑色素瘤、非小细胞肺癌等晚期实体瘤。目前该产品正在进行的I期临床试验中，客观缓解率（ORR）达66.7%，其中2例受试者实现完全缓解（CR），疗效为全球已公开TIL注册临床试验中的最优水平。在第七届TIL峰会上，华赛伯曼将展示其FAST-TIL生产平台的工艺与质量参数，包括13-19天快速生产、稳定质量控制及最新I期临床数据。此前公开信息显示，FAST-TIL采用全封闭自动化生产系统，全流程仅需14天，且肿瘤组织起始量仅需0.05g，大幅提升了TIL治疗的临床可及性。（六）HS-IT201：华赛伯曼华赛伯曼是国内较早开展TIL细胞药物开发的企业之一，目前已拥有FAST-TIL（HS-IT101）、NICE-TIL（HS-IT201）两代进入临床试验阶段的产品，并依托PowerTexp®与TMExpT®两大核心技术平台。其中，HS-IT201是在HS-IT101基础上，基于TMExpT®肿瘤微环境调控表达平台开发的产品。它通过基因改造提升TIL细胞的杀伤能力与体内存续能力，其创新设计可实现功能分子在肿瘤内的精准表达，在保障疗效的同时提升全身给药的安全性。前期体外实验证实， HS-IT201的细胞活力与杀伤效率显著优于传统TIL，拟用于非小细胞肺癌、消化道肿瘤、泌尿系统肿瘤、头颈部肿瘤等治疗。目前，HS-IT201已处于研究者发起的临床试验（IIT）阶段，计划于2025年正式进入注册I期临床试验。 TIL疗法临床案例分享 2025年美国癌症研究协会（AACR）年会上，一款创新CRISPR-TIL疗法的首次人体I期临床试验（NCT04426669）公布了震撼数据：一名对传统免疫疗法难治的年轻微卫星不稳定性高（MSI-H）转移性结直肠癌（mCRC）患者，接受治疗后实现临床完全缓解——影像学检查已无法检测到肿瘤病灶，且缓解持续时间超过24个月。该患者此前对化疗及抗PD-1/CTLA-4联合治疗均耐药，此次疗效不仅为晚期结直肠癌患者点燃了“肿瘤清零”的希望，更标志着TIL细胞疗法在结直肠癌治疗领域迈出了里程碑式的关键一步，为晚期癌症治疗提供了极具价值的临床参考。 ▲图源“AACR”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语 TIL疗法自1988年初次临床尝试以来，已历经三十余年发展。相较于其他T细胞疗法，它因能将患者自身肿瘤组织“变废为宝”，在实体瘤治疗中独具优势，甚至可帮助部分患者实现长期带瘤生存。我国TIL疗法在美式TIL疗法基础上进行特殊改良，旨在增强TIL细胞的自我扩增能力、克服肿瘤微环境抑制。近年来，我国多款新型TIL疗法陆续涌现，本次随着五款中国自研的TIL疗法成功闯入全球TIL峰会，进一步巩固了我国在全球TIL疗法研发领域的领先地位。其推出的“中国方案”正重塑全球TIL治疗发展格局，为攻克实体瘤这一医学难题提供全新思路。参考资料 [1]Qin H,et al.GT101 autologous TIL therapy in patients with recurrent and metastatic cervical cancer: A phase 1 study[J]. 2025. https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5533 [2]Han Z,et al.Exploring the safety and efficacy of GT201 as a first-in-class autologous tumor-infiltrating lymphocyte monotherapy in advanced solid tumors[J]. 2024. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2547 [3]Li N,et al.Autologous tumor-infiltrating lymphocytes (HS-IT101) with low-dose lymphodepletion and IL-2 infusion for the treatment of advanced solid tumors: A phase I clinical trial[J]. 2025. https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS2674 本文为全球肿瘤医生网原创，未经授权严禁转载

免疫疗法细胞疗法上市批准临床1期临床申请

2025-08-14

·PRNewswire

Cancer Treatment Stocks Surge as $866B Market Attracts Private Investment

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 14, 2025 /PRNewswire/ -- USA News Group News Commentary – Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Fate Therapeutics, Inc. (NASDAQ: FATE), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), and Nektar Therapeutics (NASDAQ: NKTR). Global Market Insights estimates the global oncology market at US$345.1 billion in 2025 and forecasts it will climb to US$866.1 billion by 2034, growing at a robust 10.8% CAGR. The U.S. alone is expected to contribute $377.1 billion to that total. Vision Research Reports projects an even larger figure for the global cancer drug sector, predicting it will surpass US$900 billion in sales by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its development journey—pursuing a potential registration-enabling trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) for its flagship asset, pelareorep. In its latest Q2 2025 report, the company confirmed it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin as early as Q4 2025. For investors and potential partners, this represents a clear transition from promising clinical data to potential regulatory approval in one of medicine's most challenging cancer types. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." The strategic focus on mPDAC reflects both compelling clinical results and a significant market opportunity. Pelareorep is a systemically delivered oncolytic virus designed to convert immunologically "cold" tumors—those typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. In first-line pancreatic cancer studies, pelareorep-based regimens have demonstrated a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark for standard chemotherapy alone. Even more compelling, when pelareorep was combined with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—particularly significant given that checkpoint inhibitors are not currently approved for use in this indication. These results stem from pelareorep's dual mechanism: it both replicates within cancer cells and activates the body's immune response against tumors. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME—all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Translational data from the GOBLET and AWARE-1 studies demonstrate how pelareorep transforms the tumor microenvironment, increasing PD-L1 expression, heightening interferon signaling, and mobilizing tumor-infiltrating lymphocytes in the blood—changes that correlate with tumor size reduction. This mechanistic validation, combined with survival data from over 1,100 patients across multiple studies, has solidified the company's decision to prioritize this indication. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. In line with their focus on capital efficiency, the company has terminated its At-the-Market and Equity Line of Credit facilities, citing sufficient resources to advance key milestones without near-term shareholder dilution. Regulatory advantages are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses streamline review processes and enhance the program's attractiveness to potential pharmaceutical partners. The context underscores the opportunity: pancreatic cancer remains one of the deadliest common cancers, with a five-year survival rate of less than 14%. Unlike other cancers where immunotherapies have transformed treatment, mPDAC has largely resisted immunotherapeutic approaches—making pelareorep's immune-activating mechanism particularly promising for this underserved patient population. Back in July, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes for patients and biomarker validation. The expert panel reinforced the view that pelareorep's mechanism of activating innate and adaptive immune responses is both biologically sound and commercially relevant for first-line mPDAC treatment. With this latest milestone, Oncolytics is entering a phase where FDA feedback will shape both clinical plans and potential commercial partnerships. If the agency accepts the company's proposed trial framework centered on an overall survival endpoint, the resulting study could provide definitive proof of pelareorep's market potential in mPDAC. The company expects to provide an updated clinical timeline in Q3 2025, with trial start-up activities potentially beginning as early as Q4 2025. With compelling survival data, regulatory designations in place, and an experienced leadership team driving execution, Oncolytics is positioning pelareorep for a pivotal test in one of oncology's most challenging and underserved markets. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reported strong Q2 2025 results with $60 million in total product revenue, driven primarily by its breakthrough melanoma therapy Amtagvi, which treated over 100 patients in the second quarter. "Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients," said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. "We expect our first ex-U.S. regulatory approval imminently and remain on track to provide updates on our clinical programs." The company's tumor-infiltrating lymphocyte (TIL) therapy—which uses a patient's own immune cells to fight cancer—generated $54.1 million in revenue and represents the first FDA-approved T-cell therapy for solid tumors, offering new hope for advanced melanoma patients who have tried other treatments without success. With expanded clinical trials planned for lung cancer and endometrial cancer, plus international approvals expected in Canada and other markets, Iovance is positioned to bring its innovative cancer treatment to patients worldwide. Fate Therapeutics, Inc. (NASDAQ: FATE) recently announced promising clinical progress for its off-the-shelf CAR T-cell therapy FT819, which showed lasting responses in lupus patients and received FDA clearance to begin trials for a solid tumor program targeting MICA/B proteins. While primarily focused on autoimmune diseases, the company's next-generation FT836 CAR T-cell therapy represents a significant advancement in cancer treatment as it's designed to target solid tumors without requiring harsh conditioning chemotherapy, potentially making the treatment safer and more accessible. "Building on this momentum, we are also working closely with the FDA under our RMAT designation with the goal of commencing our registrational study for FT819 in SLE and LN in 2026," said Bob Valamehr, Ph.D., MBA, President and CEO of Fate Therapeutics. "Additionally, we continue to strengthen our broader pipeline programs with an extended partnership with Ono Pharmaceuticals, and advancements in bringing our next-generation, off-the-shelf CAR T cells with Sword and Shield™ technology toward the clinic." The company's stem cell-based platform continues to advance multiple programs, including partnerships for HER2-positive solid tumors, positioning Fate as a leader in developing ready-made cancer cell therapies. Inovio Pharmaceuticals, Inc. (NASDAQ: INO) remains on track to submit its application for INO-3107 in the second half of 2025, targeting Recurrent Respiratory Papillomatosis (RRP), a rare cancer-related condition caused by HPV that affects the airways. The company's DNA medicine platform represents a novel approach to treating HPV-related diseases and cancers, with INO-3107 showing significant clinical benefit by reducing the need for repeated surgeries in RRP patients from an average of 4.1 procedures annually to just 0.9 procedures. "We believe that INO-3107 could become the preferred treatment option for Recurrent Respiratory Papillomatosis (RRP) patients and their physicians—a treatment option with the potential to change the trajectory of this disease," said Dr. Jacqueline Shea, President and CEO of INOVIO. "I look forward to building on the significant progress of this past quarter and providing updates as we work toward a potential approval date in mid-2026." Beyond RRP, Inovio's technology platform is designed to treat various HPV-related cancers and other tumors by teaching the body's immune system to recognize and fight cancer cells. With breakthrough therapy designation from the FDA and plans for a trial involving 100 patients, INO-3107 could become the first DNA-based therapy approved for treating this serious cancer-related condition. Nektar Therapeutics (NASDAQ: NKTR) reported impressive Phase 2b data for rezpegaldesleukin in treating moderate to severe atopic dermatitis, with the company positioning this immune system regulator as a first-in-class treatment for autoimmune diseases. While primarily focused on autoimmune conditions, Nektar's pipeline includes NKTR-255, a treatment designed to boost the immune system's ability to fight cancer, which is being tested in multiple ongoing clinical trials with various partners. "As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders," said Howard W. Robin, President and CEO of Nektar. "Finally, we are making significant progress on advancing preclinical studies with a new bispecific antibody, NKTR-0166, which combines the TNFR2 epitope with a validated antibody target." The company's technology platform creates novel treatments that could potentially address both autoimmune diseases and cancer by enhancing the immune system's cancer-fighting abilities. With additional data expected from hair loss trials in December 2025 and continued development of next-generation programs, Nektar is advancing a unique approach to immune system therapy that could benefit millions of patients with serious diseases. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床2期孤儿药临床结果

100 项与阿地白介素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00748	-	L03AC01	DB00041

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
肾细胞癌	美国	Chiron Corp.	1992-05-05

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
高风险神经母细胞瘤	临床3期	美国	National Cancer Institute	2009-12-21
急性髓性白血病	临床3期	法国	Chiron Corp.	2005-03-01
复发性神经母细胞瘤	临床3期	美国	National Cancer Institute	2001-10-18
复发性神经母细胞瘤	临床3期	澳大利亚	National Cancer Institute	2001-10-18
复发性神经母细胞瘤	临床3期	加拿大	National Cancer Institute	2001-10-18
复发性神经母细胞瘤	临床3期	新西兰	National Cancer Institute	2001-10-18
急性嗜碱性粒细胞白血病	临床3期	美国	National Cancer Institute	2000-11-01
急性嗜酸细胞白血病	临床3期	美国	National Cancer Institute	2000-11-01
成人急性单核细胞白血病	临床3期	美国	National Cancer Institute	2000-11-01
伴del(5q)成人急性髓系白血病	临床3期	美国	National Cancer Institute	2000-11-01

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临床结果

适应症

分期

评价

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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


AU-007 (AACR2025)	临床2期	晚期恶性实体瘤	86	AU-007	遞廠憲鏇簾選壓願艱選(糧簾襯鏇壓憲襯顧遞膚) = no Grade 5 TRAE occurred 膚夢齋網製網鏇窪鑰夢 (鹽範淵鏇夢觸膚餘鬱窪 )	积极	2025-04-29
NCT02500576 (CTgov)	临床2期	皮肤黑色素瘤 \| 转移性黑色素瘤	18	I2+fludarabine+cyclophosphamide+MK-3475 (Arm 1)	憲壓窪鹹製餘艱蓋夢醖 = 鹹餘衊簾積壓壓蓋繭淵餘夢鏇餘艱鏇鏇鬱網壓 (糧蓋蓋範鏇糧餘簾觸願, 觸餘觸醖積選築糧觸蓋 ~ 淵鹽夢餘範選膚遞鹹廠) 更多	-	2025-01-15
				TIL+fludarabine+cyclophosphamide+MK-3475+IL-2 (Arm 2)	憲壓窪鹹製餘艱蓋夢醖 = 顧繭積獵觸齋醖鏇鏇遞餘夢鏇餘艱鏇鏇鬱網壓 (糧蓋蓋範鏇糧餘簾觸願, 構積範醖窪範齋獵衊憲 ~ 廠鑰範繭蓋製艱鑰繭範) 更多
NCT03318900 (CTgov)	临床1/2期	复发性卵巢癌 \| 铂耐药性卵巢癌	5	Cyclophosphamide+IL-2 (Dose Level 1)	醖艱遞獵壓膚繭衊鹽遞(醖選繭簾繭獵淵膚襯繭) = 鹽廠醖窪壓簾構壓壓鹹鑰壓獵觸鹹衊獵夢遞願 (蓋築壓夢艱蓋築範觸範, 廠蓋繭鹹顧衊窪製範艱 ~ 網構獵夢窪範夢獵糧夢) 更多	-	2024-11-07
				Cyclophosphamide+IL-2 (Dose Level 2)	醖艱遞獵壓膚繭衊鹽遞(醖選繭簾繭獵淵膚襯繭) = 願廠襯鑰獵觸衊顧淵淵鑰壓獵觸鹹衊獵夢遞願 (蓋築壓夢艱蓋築範觸範, 壓淵夢鑰衊糧築醖鏇願 ~ 遞範鹹鹽簾願構積襯憲) 更多
NCT05267626 (SITC2024) 人工标引	临床1/2期	晚期恶性实体瘤	-	AU-007	淵艱艱積積範廠鏇膚築(鏇壓繭膚餘衊膚齋鹽夢) = None 鏇憲衊窪遞製餘繭願艱 (繭簾繭鏇築鏇獵蓋範積 ) 更多	积极	2024-11-05
				AU-007 + aldesleukin
NCT03296137 (2017-002323-25 \| ###DELETE, CTgov)	临床1/2期	转移性肿瘤 \| 肿瘤	25	infiltrating lymphocytes+ipilimumab+Fludara+Cyclophosphamide+Nivolumab+proleukin (All Participants)	鹹蓋餘衊蓋夢鑰鬱壓窪 = 積獵糧構膚餘醖鬱獵獵夢製積衊餘憲願鹹糧鹹 (獵艱選願遞艱艱積艱艱, 鑰願淵蓋築積願遞衊蓋 ~ 夢鏇膚襯膚製膚鹹齋廠) 更多	-	2024-10-26
				infiltrating lymphocytes+ipilimumab+Fludara+Cyclophosphamide+Nivolumab+proleukin (Treated Participants)	醖夢壓夢淵觸願糧廠鬱(顧範窪築夢餘鑰襯鑰構) = 範遞襯艱構鹹衊蓋築蓋繭鏇餘構繭壓鏇網齋壓 (壓憲醖製獵製餘築餘壓, 繭襯餘壓鑰築齋艱醖鑰 ~ 觸糧簾艱選觸壓膚艱遞) 更多
NCT02027935 (CTgov)	临床2期	转移性黑色素瘤	16	Autologous CD8+ Melanoma Specific T Cells+Ipilimumab+Cyclophosphamide+Aldesleukin	觸網壓選製遞壓簾壓醖(衊糧糧鹽觸衊廠構鬱餘) = 網積範鏇齋餘積積願廠衊製醖衊獵膚築壓顧廠 (衊衊選獵鹹遞齋糧襯鬱, 觸餘餘構鹽鹽壓窪築願 ~ 鬱衊構壓鬱鬱構簾襯鹽) 更多	-	2024-10-08
NCT03233828 (IL-2, CTgov)	临床3期	皮肤黑色素瘤 \| 可见病灶	1	Aldesleukin (Intralesional IL-2 Injection)	鑰簾廠鬱願選網醖選鏇(衊鹹蓋艱繭願鏇鬱選蓋) = 遞淵網夢顧鏇遞廠壓壓網遞餘膚廠餘餘鏇獵夢 (顧醖淵積窪廠簾鹹觸顧, 製鬱壓衊艱選蓋遞構製 ~ 窪觸艱築遞選製鑰製憲) 更多	-	2024-07-24
				Saline (Saline Injection)	鑰簾廠鬱願選網醖選鏇(衊鹹蓋艱繭願鏇鬱選蓋) = 觸窪範選餘願糧鏇艱衊網遞餘膚廠餘餘鏇獵夢 (顧醖淵積窪廠簾鹹觸顧, 製鹽顧餘築膚鹽壓襯艱 ~ 簾衊鹹簾艱鬱鹽膚築遞) 更多
NCT03007238 (CTgov)	临床2期	类固醇难治性移植物抗宿主病 \| 慢性移植物抗宿主病	10	ECP (Treatment (ECP+IL-2))	襯鹹範夢壓選選廠遞廠 = 製鑰築蓋網糧鏇願窪廠憲廠選觸顧選鑰艱糧願 (糧艱願顧鬱獵築壓餘鏇, 網膚網遞膚觸醖遞襯餘 ~ 鏇夢糧鑰憲鹽鹹襯鹹蓋) 更多	-	2024-04-08
				ECP (Overall Study)	鬱窪夢膚鹽鏇窪憲繭構 = 鹽構醖遞淵鹽觸憲構鑰簾憲窪齋衊衊選觸蓋壓 (醖夢壓選遞廠壓淵壓淵, 範選製獵廠願遞顧願願 ~ 鹹簾鏇窪獵鑰製醖範鏇) 更多
NCT01856023 (PROCLIVITY02, CTgov)	临床4期	转移性黑色素瘤	29	Ipilimumab+High Dose Interleukin-2 (Treatment Arm 1)	壓齋夢餘鬱餘淵遞網衊 = 範齋積願鑰廠襯蓋獵鬱糧鏇選襯蓋鑰網窪獵夢 (齋鹹醖襯夢獵衊壓襯遞, 膚艱餘鏇蓋艱餘製壓積 ~ 糧顧鏇窪襯製衊餘淵壓)	-	2023-12-05
				Ipilimumab+High Dose Interleukin-2 (Treatment Arm 2)	壓齋夢餘鬱餘淵遞網衊 = 顧蓋襯網觸廠艱繭選廠糧鏇選襯蓋鑰網窪獵夢 (齋鹹醖襯夢獵衊壓襯遞, 憲齋醖鬱構鑰襯鹽壓獵 ~ 鏇繭廠糧艱餘憲願構糧)
NCT02620865 (CTgov)	临床1/2期	转移性胰腺腺癌	2	Laboratory Biomarker Analysis+Paclitaxel Albumin-Stabilized Nanoparticle Formulation+Leucovorin Calcium+Gemcitabine Hydrochloride+Sargramostim+Aldesleukin+oxaliplatin+Irinotecan Hydrochloride+Fluorouracil	鏇鹽鏇鬱壓鹹餘襯願糧(鏇醖窪鏇衊壓膚積窪齋) = 製糧淵醖窪糧齋膚築廠衊積鬱憲壓遞憲膚築繭 (鹽夢鹽廠窪衊艱鏇鑰繭, 築餘蓋醖觸艱餘艱廠憲 ~ 鏇繭淵觸齋艱顧顧壓構) 更多	-	2023-05-15