A Double-blind, Placebo-controlled Phase Ib Study Evaluating the Safety and Toxicity of Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)

CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown.
This is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.

开始日期2026-08-31

申办/合作机构

Washington University School of Medicine

[+2]

NCT05600920

/ Recruiting临床1/2期IIT

An Open-Label, Single-Arm, Phase 1/2 Dose-Escalation Trial of Long-Acting Recombinant Human IL-7 (NT-I7, Efineptakin-Alpha) for Idiopathic CD4 Lymphopenia

Background:
Idiopathic CD4 lymphopenia (ICL) is a syndrome characterized by low levels of certain immune cells called CD4 T cells. The low CD4 T cells renders people with ICL prone to many types of severe infections, autoimmune diseases, and cancers. Although these infections and diseases can be treated whenever occur, there is currently no treatment that targeting the underlying deficiency of CD4 T cells can provide a definitive treatment for people with ICL.
Objective:
To test a new drug (NT-17) in people with ICL which can increase the number of CD4 T cells
Eligibility:
People aged 18 to 75 years with ICL who are also enrolled in NIH protocol 09-I-0102.
Design:
Participants will be screened. They will have a physical exam and blood tests. Some participants with high suspicion of central nervous system infection or history of such infections may also undergo a lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.
Participants will receive 3 doses of NT-17, each about 12 weeks apart. NT-17 is injected into the muscle of the upper arm, thigh, or buttock. They will visit the clinic 5 days before each dose and again 2 and 4 weeks after each dose. Blood will be drawn at all visits.
Participants will undergo leukapheresis 3 times. Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm.
Some visits will include a rectal swab.
Some participants may have additional tests, including a skin exam, skin biopsies, and medical imaging.
Participants will have 3 follow-up visits every 3 months after they finish treatment.

开始日期2024-11-06

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT05465954

/ Recruiting临床2期IIT

Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma

This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.

开始日期2023-01-24

申办/合作机构

Mayo Clinic

[+3]

100 项与依非白介素α 相关的临床结果

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项与依非白介素α 相关的文献（医药）

2026-07-01·CLINICAL CANCER RESEARCH

NT-I7, a Long-Acting Interleukin 7, Increases Lymphocyte Counts and Induces CD8+ T-cell Clonotype Expansion in Patients with Newly Diagnosed High-Grade Gliomas

Article

作者: Rettig, Michael P. ; Chheda, Milan G. ; Campian, Jian L. ; Tao, Yu ; Christ, Stephanie ; Huang, Jiayi ; Luo, Jingqin ; Griffith, Obi L. ; Fehniger, Todd A. ; Zhou, Alice Y. ; Ansstas, George ; Foltz, Jennifer A. ; DiPersio, John F. ; Lee, Byung Ha ; Zhang, Chaocai ; Griffith, Malachi ; Ferrando-Martinez, Sara ; Johanns, Tanner M. ; Singhal, Kartik ; Butt, Omar H. ; Tang, Justin

Abstract:

Purpose::

Standard care for high-grade gliomas (HGG) involves maximal surgical resection followed by radiation and temozolomide. Postoperative adjuvant therapy frequently causes lymphopenia, which is associated with poor prognosis. Interleukin 7 (IL7) is essential for lymphocyte development, homeostasis, and survival. NT-I7 (efineptakin alfa), a long-acting recombinant IL7, reverses lymphopenia and improves survival in murine glioma models. However, the safety, maximum tolerated dose (MTD), and impact of NT-I7 on immune cells in patients with HGG remain unknown.

Patients and Methods::

We conducted a phase I trial (NCT03687957) examining the MTD and effect of NT-I7 on lymphocytes in patients with newly diagnosed HGG. The primary endpoint was dose-limiting toxicity; secondary endpoints included absolute lymphocyte count (ALC) changes over time, overall response, progression-free survival, and overall survival. Exploratory endpoints included immune profiling at different time points using single-cell RNA sequencing (scRNA-seq) in a subset of patients.

Results::

NT-I7 was well tolerated with a MTD of 720 µg/kg. Moreover, NT-I7 significantly increased ALCs for more than 12 weeks in duration. Early elevations in CD4+, CD8+ T cells and NK cells further coincided with increased TNF and CXCL9 cytokine levels. Comprehensive immune profiling of peripheral blood T cells revealed selective clonotype expansion within CD8+, but not CD4+, T cells following NT-I7 administration. Finally, a subset of our patients with MGMT promoter–unmethylated glioblastoma, which are typically associated with a poorer prognosis, demonstrated promising clinical responses.

Conclusions::

NT-I7 has the potential to maintain and increase lymphocyte counts in patients with HGG and warrants further investigation, particularly in combination with immune-based therapies.

2026-06-08·JCI Insight

Long-acting IL-7 induces distinct transcriptomic features in peripheral T cells of patients with solid tumors

Article

作者: Kim, Sojeong ; Kim, Heewon ; Kim, Jeong Yeon ; Shin, Eui-Cheol ; Sohn, Joo Hyuk ; Chang, Jong Hee ; Jang, Hocheol ; Lee, Myung Ah ; Park, Su-Hyung ; Byun, Mi Sun ; Nam, Do-Hyun ; Jeun, Sin-Soo ; Kim, Tae Won

BACKGROUND:

IL-7 is a critical cytokine in T cell development, survival, and homeostasis. Previous preclinical and clinical studies reported that IL-7 treatment increased T cell counts, but its effect on peripheral blood T cells in cancer patients and molecular mechanisms have not been explored.

METHODS:

We investigated effects of long-acting recombinant human IL-7 conjugated to a hybrid IgD/IgG4 Fc domain (rhIL-7-hyFc) on peripheral T cells in patients with advanced solid tumors. Peripheral blood samples were collected before and after treatment, followed by analysis through single-cell transcriptomics and flow cytometry.

RESULTS:

We found that rhIL-7-hyFc induced marked expansion of proliferating T cells, and promoted transcriptional changes associated with immune activation, cell cycle progression, and antiapoptosis. Trajectory analysis revealed that posttreatment T cells had distinct transcriptional states enriched for cytokine- and TCR-mediated signaling pathways. Notably, a second dose administered after 3 weeks yielded diminished proliferation and minimal transcriptional changes, which were independent of antidrug antibody or CD127 downmodulation. Examination of elements of the IL-7 signaling pathway revealed intact proximal signaling (e.g., STAT5 phosphorylation) but downregulation of distal elements, including PIM-1 kinase and c-Myc.

CONCLUSIONS:

Our results demonstrate that rhIL-7-hyFc induces robust peripheral T cell expansion and activation in patients with solid tumors, supporting its potential use for lymphopenic patients treated with cancer immunotherapy.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT03478995 and NCT03619239.

FUNDING:

National Research Foundation of Korea (NRF-2022R1A2C3007292 and RS-2024-00439160), Ministry of Food and Drug Safety (RS-2025-02213409), and the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (RS-2025-25460003).

2026-06-01·RESPIRATORY MEDICINE

Recombinant human interleukin-7 for patients with infection-associated lymphopenia: a systematic review and meta-analysis

Review

作者: Shi, Yuejuan ; Lu, Xin ; Jiang, Xin ; Tu, Ye ; Wang, Zhibin ; Chen, Linlin

PURPOSE:

This study aims to evaluate the efficacy of recombinant human interleukin-7 (rhIL-7) in treating lymphopenia and related clinical outcomes in patients with infection-associated lymphopenia through a meta-analysis.

METHODS:

A Literature retrieval was conducted across databases, including the Cochrane Library, Web of Science, PubMed, Embase, SinoMed, CNKI, Wanfang, and VIP from the inception until October 2025. Randomized controlled trials of rhIL-7 for the treatment of lymphopenia were screened and identified for eligibility. Primary outcomes included absolute lymphocyte counts (ALC), mortality, intensive care unit (ICU) length of stay, and incidence of secondary infections.

RESULTS:

Four studies were included, covering sepsis and COVID-19. In septic patients, rhIL-7 significantly increased ALC (MD = 1.33 at 3 weeks; 95% CI [0.29, 2.38]; MD = 1.14 at 4 weeks; 95% CI [0.02, 2.25]), CD4⁺ T-cell counts (MD = 0.56 at 3 weeks; 95% CI [0.08, 1.05]) and CD8⁺ T-cell counts (MD = 0.40 at 2 weeks; 95% CI [0.05, 0.76]). However, rhIL-7 failed to reduce mortality (RR = 1.01; 95% CI [0.36, 2.81]) or the incidence of secondary infections (RR = 1.05; 95% CI [0.48, 2.30]) in patients with sepsis. In patients with COVID-19, rhIL-7 did not significantly increase ALC at 30 days (MD = 0.46; 95% CI [-0.15, 1.08]) or reduce mortality (RR = 0.85; 95% CI [0.55, 1.33]), but it did significantly reduce the incidence of secondary infections (RR = 0.58; 95% CI [0.46, 0.74]; p < 0.0001). A combined analysis revealed that rhIL-7 significantly increased ALC (MD = 1.15 at 3 weeks; 95% CI [0.47, 1.84]; MD = 0.80 at 4 weeks; 95% CI [0.24, 1.36]) and reduced the risk of secondary infections (RR = 0.64; 95% CI [0.50, 0.81]), but had no effect on mortality or ICU length of stay.

CONCLUSION:

RhIL-7 effectively ameliorates sepsis-associated lymphopenia but does not improve prognosis. Although rhIL-7 reduces the incidence of secondary infections in COVID-19 patients, confounding factors related to the pandemic context must be taken into account.

项与依非白介素α 相关的新闻（医药）

2026-03-03

·百度百家

医教研防深度融合，双院携手打通溶瘤病毒到临床最后一公里

当国家肿瘤区域医疗中心的建设按下快进键，中国医学科学院肿瘤医院与中国医科大学附属第一医院（中国医学科学院肿瘤医院辽宁医院）把“医教研防”四维一体写进了合作基因。2023年初，两院共同在《Small》（中科院一区，IF 15）发表综述，系统梳理溶瘤病毒从实验室到患者的全链条瓶颈，为后续安全、高效的疗法铺平理论道路。这篇论文只是序章——一年来，他们在国家级创新平台、科研课题、临床试炼、患者招募等环节全面提速，交出了一份可复制的“辽宁方案”。 2.1 ◉ 医师联手，顶级期刊连发依托国家区域医疗中心临床研究平台，医生—护士—机构三方同步发力，实现“科研—临床”两位一体。医师团队立足临床试验，在“Small”、“Nano Today”、“Cancer Letters”等顶刊连续发表多篇溶瘤病毒主题高水平论文；系统总结近期单药及联合治疗的疗效与安全性，为溶瘤病毒疗法临床转化按下加速键。成果论文“Oncolytic virus-driven bio-therapies from bench to bedside”成功登陆《Small》，为后续研发提供坚实的理论基础。 2.2 ◉ 护理赋能，患者招募更“轻” 主管护师密切交流，在《中国新药杂志》合作发表论文“肿瘤患者参与药物临床试验现状及影响因素研究”。调研显示，八成以上患者希望在知情同意环节获得更直观的预后信息，这一发现直接指导后续临床试验的患者教育路径设计，让“招得到”更“留得住”。 2.3 ◉ 机构护航，规范“看得见” 中关村玖泰药物临床试验技术创新联盟与平台共建“临床试验用药品中心化管理评估规范”，首次把“流程—评估—结果”三环节量化成可复制的标准文档，为机构内部质控与外部审评提供统一尺子。 I期临床试验中心与GCP中心共享平台，整合院企、院校、院所资源，2022年累计获批国家级课题经费480万元。亮点速览：科技部重点研发计划——“诊疗装备与生物医用材料”专项（批号：2022YFC2403401）落地，罕见肿瘤可再生原代细胞生物银行上线； “干细胞研究与器官修复”专项（批号：2022YFA1105301）同步参与；国家生物药技术创新中心核酸药物“揭榜挂帅”项目花落溶瘤病毒产业化； 3项溶瘤病毒产品临床试验同步推进，从实验室到患者体内只用了不到18个月。两院共建“临床试验绿色便捷通道”，2022年覆盖胃癌、直肠癌、乳腺癌、肺癌、肾癌等实体瘤，包含术后辅助、多线姑息等治疗阶段，纳入靶向、免疫、溶瘤病毒、ADC等多种创新药物。通过国家肿瘤区域医疗中心平台，引入最前沿、最热门、最优质的临床试验资源，实现“同质化服务”——患者在家门口就能接受与国际接轨的治疗方案。共建受试者招募网络，电视、微信公众号、自媒体多点触达，把国家癌症中心的优势“点对点”送到患者面前，“点对面”辐射辽宁全省。 4.1 ◉ 2022年部分在研项目速览 Capivasertib+紫杉醇三阴性乳腺癌一线治疗Ⅲ期研究抗Globo-H疫苗OBI-822/OBI-821 三阴性乳腺癌 Ⅲ期研究吡罗西尼片联合氟维司群 HR阳性、HER2阴性晚期乳腺癌 III期研究抗EGFR/c-Met双特异性抗体MCLA-129 晚期实体瘤患者Ⅰ/Ⅱ期研究 FCN-437c联合来曲唑或阿那曲唑±戈舍瑞林 HR阳性、HER2阴性乳腺癌 III期研究 ZN-A-1041肠溶胶囊 HER2阳性实体瘤患者 I期研究注射用BGC0228 晚期实体肿瘤 I期临床研究 TQB2450注射液晚期非鳞非小细胞肺癌 Ⅲ期临床试验注射用SKB264 三阴性乳腺癌 III期临床试验 JAB-21822联合JAB-3312用于KRAS p.G12C突变晚期实体瘤 I/IIa期研究丁苯酞软胶囊预防性治疗紫杉类所致周围神经病变II期临床试验 D-0502与氟维司群乳腺癌患者 Ⅲ期临床研究注射用维迪西妥单抗联合特瑞普利单抗尿路上皮癌 III期临床研究重组人源化抗BTLA单克隆抗体晚期实体瘤 I期临床研究 TJ107与帕博利珠单抗注射液联合治疗实体瘤患者 Ⅱ期临床研究 LVGN7409单药治疗恶性肿瘤 I期试验 JAB-21822用于KRAS p.G12C与STK11共突变且KEAP1野生型非小细胞肺癌Ib/II 期研究 4.2 ◉ 审查提速：5天立项、2个月启动跨区域协作模式把伦理审查、合同签署、项目启动拆成“三步走”：立项5个工作日、伦理7个工作日、合同7个工作日，整体耗时压缩到2个月以内。申办方点赞的“IN10018联合PLD卵巢癌项目”从立项到启动会仅用5天，刷新了当时国内多中心最快纪录。目前累计互认伦理项目新立14项、在研27项，真正让数据多跑路、患者少跑腿。

2025-12-31

·Pharmaceutical Technology

Emmaus, NIT sign Endari distribution agreement

Endari is indicated to reduce acute complications of sickle cell disease in adults and children aged five years and older. Credit: Babul Hosen/Shutterstock.com. Emmaus Life Sciences has entered into a licensing and exclusive distribution agreement with NeoImmuneTech (NIT) for Endari, a prescription-grade L-glutamine oral powder. The agreement grants NIT exclusive rights to distribute, market, and sell Endari and its generic equivalents for sickle cell disease in Canada, and the US, its territories. Under the terms of the agreement, Emmaus will receive an upfront payment and a royalty on NIT’s product sales. The effective date of the agreement is subject to NIT securing the required regulatory licences and approvals for the sale and distribution of Endari in the agreed regions. Endari is indicated to reduce acute complications of sickle cell disease in adults and children aged five years and above. It is currently approved for marketing in the US, Kuwait, Bahrain, Israel, Qatar, Oman, and United Arab Emirates. The product is also available on a named patient or early access basis in the Netherlands, France, and the Kingdom of Saudi Arabia, with an application for marketing authorisation anticipating final action by the Saudi Food & Drug Authority. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Emmaus chairman and CEO Willis Lee said: “Emmaus has continuously reassessed its commercialisation strategy to maximise global value of Endari. While the US market represents a mature and stable revenue base, we believe other regions such as the Middle East, Brazil, and Europe offer greater growth potential.” NIT acting CEO Tae Woo Kim said: “The completion of this definitive agreement is highly meaningful, as it establishes a foundation for direct commercialisation of an FDA-approved therapy. “The US distribution, reimbursement, and marketing infrastructure built through Endari will also create significant synergies for the future commercialisation of our proprietary pipeline, including NT-I7.” In July 2023, Emmaus received marketing authorisation from the Oman Ministry of Health for Endari (L-glutamine oral powder) for the treatment of sickle cell disease in patients aged five years and above. Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact

上市批准引进/卖出

2024-11-28

·PRNewswire

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法引进/卖出临床3期疫苗细胞疗法

100 项与依非白介素α 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11957	-	-	DB16395

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
特发性CD4阳性T淋巴细胞减少症	临床2期	美国	NeoImmuneTech, Inc.	2024-11-06
胶质母细胞瘤，IDH野生型	临床2期	美国	NeoImmuneTech, Inc.	2023-01-24
胶质母细胞瘤，IDH野生型	临床2期	美国	Merck Sharp & Dohme LLC	2023-01-24
神经胶质肉瘤	临床2期	美国	NeoImmuneTech, Inc.	2023-01-24
神经胶质肉瘤	临床2期	美国	Merck Sharp & Dohme LLC	2023-01-24
高级别星形细胞瘤	临床2期	美国	NeoImmuneTech, Inc.	2023-01-24
高级别星形细胞瘤	临床2期	美国	Merck Sharp & Dohme LLC	2023-01-24
皮肤肿瘤	临床2期	-	NeoImmuneTech, Inc.	2022-04-27
局部晚期头颈部鳞状细胞癌	临床2期	韩国	NeoImmuneTech, Inc.	2022-03-01
局部晚期头颈部鳞状细胞癌	临床2期	韩国	Genexine, Inc.	2022-03-01

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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


NCT04984811 (CTgov)	临床2期	非小细胞肺癌 \| 非小细胞肺癌 III期 \| 转移性非小细胞肺癌	33	Atezoliaumab+NT-I7	鬱遞艱膚蓋糧艱醖衊糧 = 範壓遞選鏇淵憲選襯觸鹹醖網製鏇廠襯淵鑰願 (顧顧膚選鬱廠鹹製壓夢, 鏇願簾膚鹽鏇憲鏇餘壓 ~ 觸壓齋鏇壓遞簾膚願鑰) 更多	-	2026-06-11
NCT03901573 (CTgov)	临床1/2期	梅克尔细胞癌 \| 黑色素瘤 \| 转移性黑色素瘤 ... 更多	31	NT-I7+atezolizumab (Phase 1b-Dose Level 1)	餘齋餘窪鏇遞鑰積構獵 = 壓齋鑰鏇憲選製窪壓構獵糧顧鬱淵獵獵餘夢鏇 (餘齋簾淵壓艱構糧願蓋, 選膚範廠網壓遞顧憲蓋 ~ 範衊遞繭衊餘廠醖艱獵) 更多	-	2025-10-22
				NT-I7+atezolizumab (Phase 1b-Dose Level 2)	餘齋餘窪鏇遞鑰積構獵 = 艱艱鬱築糧顧築構膚艱獵糧顧鬱淵獵獵餘夢鏇 (餘齋簾淵壓艱構糧願蓋, 選窪蓋襯夢夢觸選觸鹽 ~ 遞製繭夢壓範窪鬱淵糧) 更多
NCT04893018 (Phase I study of efineptakin alfa (NT-I7), Pubmed \| J Immunother Cancer)	临床1期	卡波西肉瘤 immune dysfunction	8	NT-I7 480 µg/kg	繭蓋範淵壓憲網鹽醖製(繭廠餘鹽鹹鹽艱醖艱積) = Injection site reaction was a dose-limiting toxicity in one participant at DL1 夢壓觸憲壓襯衊餘膚蓋 (簾蓋壓鏇願遞鹽夢膚簾 ) 更多	积极	2025-02-01
CTIM-24 (SNO2024)	临床2期	高级别胶质瘤 IDH-wildtype glioblastoma \| MGMT methylation status	22	rhIL-7-hyFc (720mcg/kg)	鬱膚鏇憲築選鹹鑰襯遞(獵鬱糧窪簾構憲遞鹹廠) = 襯鏇蓋選選鏇窪膚範築願糧艱齋廠艱餘遞網築 (顧範餘製觸簾觸廠蓋憲 ) 更多	积极	2024-11-11
				Placebo	鬱膚鏇憲築選鹹鑰襯遞(獵鬱糧窪簾構憲遞鹹廠) = 鑰網衊選醖廠範顧鬱醖願糧艱齋廠艱餘遞網築 (顧範餘製觸簾觸廠蓋憲 ) 更多
NCT05075603 (ESMO2024) 人工标引	临床1期	弥漫性大B细胞淋巴瘤	11	NT-I7 (efineptakin alfa)	選範範獵餘艱築構製艱(簾衊鏇憲壓壓鬱鬱繭顧) = most commonly injection site erythema and injection site swelling (2 subjects each, 18.2%) 鑰壓顧獵憲鑰壓鹽選窪 (餘鹽齋艱廠夢願糧積夢 )	积极	2024-09-13
NCT04893018 (Phase I study of efineptakin alfa (NT-I7), CTgov)	临床1期	艾滋病相关性卡波西肉瘤	8	NT-I7 (Efineptakin Alfa) (NT-I7 (Efineptakin Alfa) Dose Level 1)	簾襯蓋遞糧餘製鏇鏇範 = 齋鬱顧網積醖醖蓋窪淵憲簾遞餘窪餘顧壓艱構 (積艱顧膚獵壓淵構淵憲, 鹹築壓網鹽積蓋鬱膚醖 ~ 鑰鏇積積窪觸築憲餘鹹) 更多	-	2024-06-27
				NT-I7 (Efineptakin Alfa) (NT-I7 (Efineptakin Alfa) Dose Level 2)	簾襯蓋遞糧餘製鏇鏇範 = 觸選範構窪簾鹽遞蓋淵憲簾遞餘窪餘顧壓艱構 (積艱顧膚獵壓淵構淵憲, 鏇願糧衊艱鑰網糧齋構 ~ 鏇淵糧餘顧構壓築積齋) 更多
NCT04332653 (ASCO2024) 人工标引	临床2期	微卫星稳定型结直肠癌 \| 胰腺癌一线 Microsatellite Stable (MSS)	53	NT-I7 1200 µg/kgPembrolizumab	鏇廠獵鏇構積築網獵艱(鏇繭鑰築糧網網鏇積鹹) = 鬱築繭鹹鏇顧鏇膚蓋夢鑰憲壓艱窪顧壓艱網製 (鏇窪築壓鬱憲構製襯積 )	积极	2024-05-24
				NT-I7olizumab 200 mgPembrolizumab	-
NCT04332653 (ASCO2024) 人工标引	临床2期	微卫星稳定型结直肠癌 \| 胰腺癌	98	NT-I7opembrolizumabg	鑰壓衊網憲憲餘鹽壓衊(夢選窪鹹淵鏇齋壓糧製) = 廠觸觸築鹹網艱壓壓餘獵壓鑰夢觸憲遞獵簾觸 (壓願壓鏇遞鏇網衊獵夢 ) 更多	积极	2024-05-24
				NT-I7 pembrolizumab	鑰壓衊網憲憲餘鹽壓衊(夢選窪鹹淵鏇齋壓糧製) = 蓋糧選鹹觸鏇積壓築網獵壓鑰夢觸憲遞獵簾觸 (壓願壓鏇遞鏇網衊獵夢 ) 更多
NCT05286060 (GENUINE, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	人乳头瘤病毒相关的头颈部鳞状细胞癌新辅助 HPV-16 Positive \| HPV-18 Positive	11	GX-I7+GX-188E+pembrolizumab	衊憲餘遞餘壓顧淵壓憲(餘範夢範簾淵鹹網鹹齋) = 顧蓋襯築鑰鬱醖築範衊繭餘憲鑰窪製艱範糧襯 (鏇構鬱構艱糧膚壓願積 ) 更多	积极	2023-05-26
ASH 12022 \| ASH 22022 人工标引	临床1期	复发性弥漫性大B细胞淋巴瘤	7	Tisagenlecleucel+Efineptakin Alfa	糧窪艱夢鹹鹽製廠觸鹽(糧遞淵簾簾窪廠鏇積憲) = 遞鹹鏇製範築觸鹹鏇鑰簾窪鏇齋範網淵廠製糧 (夢簾鬱壓製鏇網鹽醖鑰 ) 更多	积极	2022-11-15