Teplizumab

占击左上方 可关注我们 项目优势 一种人源化抗CD3抗体，与T细胞表面的CD3抗原结合，通过部分激动或阻断T细胞信号传导，诱导自身反应性T细胞失活或凋亡，减少对胰岛β细胞的免疫攻击，从而保护β细胞功能，并且可增加外周血中Treg细胞的比例，Treg细胞能抑制过度的免疫反应，维持免疫耐受，进一步减轻对胰岛β细胞的损伤。从而有助于延缓β细胞功能衰退，使患者在较长时间内维持一定的胰岛素分泌能力，减少对胰岛素注射的依赖。 【获批情况】2025年9月3日，在中国获批上市，适用于成人和8岁及以上儿童1型糖尿病2期患者，以延缓3期1型糖尿病发病。 项目介绍   招募人群：近期确诊的3期1型糖尿病患者 用药情况：teplizumab，一种CD3靶向的单克隆抗体， 项目周期：访视次数33次，筛选期1次，2个干预期每个疗程12次（每天1次），第1个疗程后的随访期3次（W4、W12、W23），第2个疗程后的随访期5次（W30、W39、W52、W65、W78），一定的交通补助，具体以医院知情为准 研究分组：按2:1随机分至teplizumab组或安慰剂组 入选标准   1、年龄1-25岁 2、诊断为3期1型糖尿病（T1D) 3、诊断时间为4周内，如需接种活疫苗，可延长4周 4、筛选时随机C肽水平≥0.2 nmol/L（3岁以下儿童只要能检测出C肽即可） 5、至少有一种1型糖尿病（T1D)自身抗体阳性： 谷氨酸脱羧酶（GAD-65） 胰岛素瘤抗原-2（IA-2） 锌转运蛋白8（ZnT8） 胰岛素（外源性胰岛素治疗开始后14天内检测） 胰岛细胞胞浆自身抗体（ICA） 重要排除情况： 1、合并其他自身免疫性疾病 2、既往接受过全身性免疫抑制药物或免疫调节生物疗法治疗 参加城市   北京、上海、广州、深圳、天津、沈阳、长春、哈尔滨、南京、杭州、济南、武汉、长沙、萍乡、成都 提交资料   1、3期T1D的诊断病历（关注诊断时间）； 2、自身抗体阳性报告； 3、既往随机C肽水平的报告； 4、近1个月内降糖治疗记录； 5、近一个月内接受的药物治疗； 📢 重要须知 Important Notices 1、项目性质 🔎所有临床试验均在全国三甲医院开展，具体启动时间、补助政策等以医院知情为准。 ⏩本研究严格遵守国家法律法规和伦理规范，您的所有个人信息将被严格保密。最终能否入组需经医院专业评估，请知悉。 2、费用说明 💰项目期间所有相关检查费用由申办方全额承担，参与者无需支付任何费用。 3、咨询与报名 ➡️若您或亲友符合招募条件，可扫描下方二维码，获取一对一专业咨询。 ♾️更多临床招募信息，请关注公众号 「医缘招募」 实时更新。 📌 特别提示：扫码即享专属顾问服务，全程协助匹配优质临床项目！ ☎️咨询电话：15530108929 📲或扫下方二维码添加微信，了解更多♾️ 咨询报名 请扫码添加微信 了解更多临床项目

This article presents the longest published follow-up of patients with type 1 diabetes treated with TREGs. Long-term effectiveness and safety have been confirmed by data published in the prestigious journal Diabetes, Obesity and Metabolism. The therapy delays the onset of type 1 diabetes symptoms and works for up to 12 years after its completion without causing serious side effects. The study results show a significant advantage of PolTREG therapy compared to currently used therapies in the treatment of diabetes. The prestigious journal “Diabetes, Obesity and Metabolism”, which sets trends in diabetes treatment, has published an article summarizing the analysis of clinical data confirming the long-term safety and effectiveness of autologous TREGs developed by PolTREG used in the treatment of type 1 diabetes. The study clearly demonstrated that the therapy delays the onset of type 1 diabetes symptoms and is effective for up to 12 years after treatment ends. This is the longest published follow-up report of patients with type 1 diabetes treated with TREGs and an important step in this field. It demonstrates that a well-formulated TREG product can provide lasting immune balance and help preserve beta-cell function long after treatment ends. “The power of TREG cells in treating autoimmune diseases has been confirmed by the results of our research. Their discovery was also recognized and recognized with a Nobel Prize this year. The results of the analysis of our study on the treatment of type 1 diabetes with TREG cells are spectacular; these are the best results that could have been expected. The publication of this article culminates the research process and opens up completely new possibilities for us. This is data we have been collecting for years, but only this year did we have statistics that opened further doors for us and attracted the attention of world-renowned scientists who became involved in PolTREG and began ongoing collaboration with us. I would like to thank the parents and our patients who participated in the study when they were young children. For the entire research team, there is no greater reward than confirmation that in the research group—those young adults who were given the therapy developed by PolTREG years ago—we have halted the progression of the disease. The process of the abnormal immune response attacking their own organs has been halted, and their pancreases continue to secrete insulin,” says Prof. Piotr Trzonkowski, President of the Management Board of PolTREG SA. In the study, conducted by the Medical University of Gdańsk and PolTREG, patients were monitored for 7.5 to 12 years after receiving autologous TREG lymphocytes in childhood. The full open-access article in the journal Diabetes, Obesity and Metabolism is available here:https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.70330The analysis described in this article included 51 participants who participated in the PolTREG clinical trial as children. These are now adults, with 7.5 to 12 years having passed since receiving TREG cells or standard therapy. Analysis of over 700 indicators demonstrated the safety of this therapy: no serious adverse events, no tumors, and no safety issues. At the same time, long-term clinical benefits were clearly demonstrated: higher C-peptide levels, longer remission, and insulin independence compared to standard therapy. The best results were achieved with the Treg lymphocyte + anti-CD20 antibody treatment regimen. “This prestigious journal, with its wide reach and authority, ensures that the results published there will reach a large audience in the world of medicine and business and strengthen our position in both environments. Doctors and patients have been waiting for this very therapy, which inhibits the autoimmune process of destruction of insulin-producing cells, for over a hundred years. The drug Tzield has brought about a huge change in thinking about early detection and treatment of diabetes, but our therapy looks even more promising. Evidence of the safety and effectiveness of our therapy in a group of patients with symptoms of type 1 diabetes allowed us to obtain approval from the EMA and initially from the FDA to conduct a clinical trial in the first stage of this disease, when the disease process is still latent and many years will pass before symptoms appear. If the published results are so positive in patients who have retained the function of only 10-20% of insulin-producing cells, we can expect them to be spectacular when these cells still have 80-90%. Furthermore, in these children, often as young as 3 years old and generally considered healthy, natural cells in an autologous model are therapy of choice. It is difficult to expect the EMA or FDA to approve genetically modified cell therapy before it has proven its effectiveness, and above all, its safety, in adult or symptomatic patients. This gives us a huge advantage over potential competitors, who will not have such results for a long time. That is why we are seeing such strong interest in the US, where the best scientific and clinical centers are located and where our competitors operate. As a result, PolTREG is ready to enter the US. We established a local subsidiary, Immuthera, in the US and began intensive collaboration with the most important global opinion leaders in the field of diabetes. They considered our results groundbreaking and supported us in preparing the meeting with the FDA, which so positively impacted the prospects of registering our therapy in the US. Already at the pre-IND stage, we received a suggestion that the study conducted in the US would be the registration study, and the results from the study currently conducted in Poland would be included in the statistics considered by the FDA. This entire sequence of events puts us in a completely new place in terms of the company’s business strategy and means that New opportunities are opening up for us. Considering that the pharmaceutical company paid almost USD 3 billion for the rights to Teplizumab, we are counting on interest in our therapy from businesses,” emphasizes Mariusz Jabłoński, member of the management board of PolTREG SA. Diabetes is a currently incurable and devastating disease – it is the leading cause of blindness, kidney failure, heart attacks, strokes, and lower limb amputations. It ranks seventh among the leading causes of death worldwide. Only in 2022, the drug Tzield (Teplizumab) was approved, for now exclusively in the US. It was the first treatment for type 1 diabetes, delaying the progression of the disease by 2-3 years. At the same time, the treatment process involves a difficult hospitalization, lasting several or even several dozen days, and additionally, it exposes patients to toxicity and severe side effects. Despite certain shortcomings, Teplizumab was acquired by an international pharmaceutical company for nearly $3 billion. *** PolTREG SAPolTREG is a biotechnology company focused on developing innovative therapies using T-regulatory T-cells (TREGS), as well as developing combination therapies combining TREGs with antibodies. The company is a global leader in cell therapies based on polyclonal TREG cells. The company’s scientists and co-founders conducted the world’s first human administration of a TREG preparation. Therapeutic areas in which PolTREG therapies are being developed include various autoimmune diseases such as type 1 diabetes, multiple sclerosis, and amyotrophic lateral sclerosis. More information on the website: https://poltreg.com/pl/ Immutheris a pioneer in the field of innovative cell therapies being clinically developed in the United States and Canada. The company will conduct clinical trials of projects originally developed by PolTREG under FDA regulations in the US, as well as projects licensed from US institutions. Immuthera will have full access to PolTREG’s research and development facilities and its portfolio of projects. The company is currently seeking investors to begin manufacturing and clinical development of these therapies in the US. More information at: https://immuthera.bio/