Sydney, Australia—July 2025—With in-vivo CAR-T therapies gaining global momentum, a new whitepaper from Novotech a leading global full-service clinical Contract Research Organization (CRO) and scientific advisory company offers insight into this next frontier of immunotherapy. In-Vivo CAR Therapies – Global Research and Development Landscape (2025) report explores the accelerating innovation in in-vivo CAR-T (Chimeric Antigen Receptor) technologies and their potential to reshape treatment across oncology, autoimmune diseases, and other complex indications.
Traditional ex-vivo CAR-T therapies require extracting a patient’s T cells, engineering them in specialized labs, and reinfusing them, a process that is time-intensive, expensive, and logistically complex. These barriers have significantly restricted patient access.
In contrast, in-vivo CAR-T therapies aim to overcome these challenges by engineering T cells directly within the patient’s body using delivery technologies such as viral vectors, lipid nanoparticles (LNPs), and advanced mRNA platforms. The result: faster, more scalable, and potentially off-the-shelf treatments that can expand access, reduce costs, and streamline the patient experience.
In-vivo CAR-T platforms are now being explored not only for hematologic malignancies, but also for solid tumors and autoimmune diseases—areas where traditional CAR-T approaches have faced limitations. Emerging delivery innovations and new combination strategies are driving this expansion.
As a result, in-vivo CAR-T therapies are positioned to reshape clinical practice, expanding their applicability across oncology, autoimmune diseases, and beyond
The report provides key insights for sponsors, investors, and researchers into one of the most transformative areas of next-generation cell therapy. It includes:
- The technological evolution of CAR platforms and delivery systems.
- The expanding global pipeline of in-vivo CAR assets and clinical programs.
- Innovations in lipid nanoparticle (LNP) and viral vector delivery strategies.
- Commercial and regulatory considerations shaping future adoption.
- Opportunities for in-vivo CAR approaches beyond oncology, including autoimmune diseases and fibrosis.
Novotech has an established track record of supporting in-vivo CAR-T programs globally, including conducting the world’s first in-vivo CAR clinical trial, highlighting its leadership and deep expertise in advanced therapeutics, including gene and cell therapies. The company has also conducted more than 100 ATMP studies, spanning gene therapies, gene-modified cell therapies, and mRNA products. Novotech is also actively partnering with biotech sponsors advancing in-vivo CAR pipelines.
Download the full whitepaper to explore the key trends and opportunities driving the future of in-vivo CAR-T therapy.
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Toyna Chin
关于诺为泰Novotech-CRO.com
Novotech(诺为泰)作为一家可提供全方位服务的国际性临床研究组织 (CRO) 和科学咨询公司,深受生物科技公司以及中小型制药公司的信赖,并指导其在各个阶段的药物开发。
公司在全球范围内拥有30多个办公地点,主要分布在亚太地区、北美和欧洲,并与5000多个试验机构建立了紧密的合作关系,为客户提供丰富的临床试验资源网络,帮助客户充分利用关键试验区域,广泛接触不同的受试者群体,推动变革性疗法更快惠及患者。
通过以客户为中心的服务模式,诺为泰无缝整合人才、流程和技术,提供定制化解决方案,加速变革疗法快速上市。通过构建紧密的合作伙伴关系,诺为泰坚定不移地支持客户实现研究目标,赋能创新,推动全球医疗健康发展。凭借在临床试验执行和创新方面的卓越表现,诺为泰已荣获多项殊荣,包括连续19年蝉联弗若斯特沙利文CRO年度公司奖 (Frost & Sullivan CRO Company of the Year)。依托深厚的临床领域与监管专业知识,结合对当地市场的深刻洞察,公司致力于简化临床试验流程,优化数据分析,并加快受试者招募策略的实施。
我们与客户携手并进,加速科研成果的落地转化,改善全球患者结局,践行我们推动创新、实现卓越成果的使命。
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