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市场调查报告书
商品编码
1750227
癌症的γδT细胞疗法的全球市场:市场趋势,技术平台,临床试验预测(2031年)Global Gamma Delta T Cell Cancer Therapy Market Trends, Technology Platforms & Clinical Trials Outlook 2031 |
全球癌症的γδT细胞疗市场趋势,技术平台,临床试验预测(2031年)报告的结论
适应性γδT细胞 (Yδ)免疫疗法是一种新型免疫疗法,利用独特的T细胞亚群来辨识并摧毁癌细胞。典型的αβ(aB)T细胞辨识由主要组织相容性复合体(MHC)分子呈现的抗原,而YδT细胞则以MHC非依赖的方式被压力诱导的配体和磷酸化抗原活化。这使得它们能够检测并针对多种肿瘤,包括那些传统免疫警戒机制未针对的肿瘤。 YδT细胞兼具先天免疫和适应性免疫的特性,并具有即时应答和免疫记忆的能力,使其成为现成的过继细胞疗法的理想候选者。
在癌症治疗中,YδT细胞因其无需技术难度高且成本高昂的肿瘤特异性抗原或基因改造即可摧毁恶性细胞的潜力而备受关注。其固有的细胞毒性,加上可以使用同种异体细胞(来自健康捐赠者)的可能性,为大规模生产和廉价治疗提供了途径。迄今为止,大多数临床研发都集中在血液系统恶性肿瘤领域,该领域前景广阔。 Yδ T 细胞可以侵入骨髓和其他淋巴器官,并透过释放细胞激素、直接细胞毒性和改变肿瘤微环境来影响肿瘤。
迫切需要新的癌症疗法,尤其是像急性骨髓性白血病 (AML) 这样的血液系统癌症,这类癌症容易復发或对常规疗法产生抗药性。对于缓解后復发或有残留疾病 (MRD) 的患者,治疗选择有限,预后通常较差。 Yδ T 细胞疗法具有独特的优势,可以填补这一空白,它提供了一种可能有效、安全且易于获取的现成产品,并且不存在自体 T 细胞疗法的后勤问题,例如生产暂停和患者个体差异。
TC Biopharm 在该领域的临床开发中处于领先地位。该公司最先进的候选产品 OmnImmune(原名 TCB-002)目前正在进行针对急性髓性白血病 (AML) 的关键性 II/III 期临床试验。 OmnImmune 是一种同种异体 Yδ T 细胞疗法,旨在快速靶向并摧毁癌细胞,同时避免对正常组织的损害。该临床计画是全球 Yδ T 细胞产品线中最先进的计画之一,彰显了 TC Biopharm 在该领域新兴的领导地位。除了 OmnImmune,该公司还有多个 Yδ T 细胞候选药物正在开发中,用于治疗各种癌症。
TC Biopharm 近期最重要的进展之一是其 TCB008 候选药物的开发,该药物目前正在进行 II 期 ACHIEVE 试验。 2025 年 6 月,该公司报告称,B 组首例患者(先前復发且可检测到微小残留疾病 (MRD))在接受两次给药后实现了完全分子缓解 (CRT)。治疗后检测不到NPM1转录本显示疗效显着且持久,展现了TCB008作为血液系统癌症缓解后治疗的潜力。这项结果凸显了YδT细胞强大的标靶免疫功能,并证明了其作为一种新型治疗策略的作用。
在全球范围内,大多数对YδT细胞的研究仍停留在血液系统恶性肿瘤领域,针对实体肿瘤的项目较少。部分原因是实体瘤利用更复杂的微环境和免疫逃脱机制。然而,人们正在尝试将YδT细胞疗法应用于这些更具课题性的治疗环境。从地区来看,美国公司在YδT细胞疗法市场占据主导地位,其次是越来越多的中国公司。这些地区在细胞疗法设施和技术方面投入了大量资金,促进了该疗法从实验室到临床的快速转变。
展望未来,YδT细胞疗法前景光明,但其在实体肿瘤中的临床验证仍需持续。生产和生物标记驱动策略的进步有望将YδT细胞的应用扩展到更多癌症类型。在TC Biopharm等领导企业的引领下,该领域可望为肿瘤学领域尚未满足的重大需求提供改变生命的治疗方案。
Global Gamma Delta T Cell Cancer Therapy Market Trends, Technology Platforms & Clinical Trials Outlook 2031 Report Conclusions:
Adoptive gamma delta (Yδ) T cell therapy is a novel type of immunotherapy that utilizes a unique subset of T cells to recognize and destroy cancer cells. While typical alpha-beta (aB) T cells identify antigens presented by major histocompatibility complex (MHC) molecules, Yδ T cells are activated by stress induced ligands and phosphoantigens in an MHC independent fashion. This enables them to detect and target a wide variety of tumor types, including those that are not targeted by conventional immune vigilance. Yδ T cells possess characteristics of both innate and adaptive immunity, allowing them to have the ability for immediate response and immune memory, which make them particularly good candidates for off-the-shelf adoptive cell therapies.
In cancer, Yδ T cells are under investigation for their potential to destroy malignant cells without the requirement of tumor-specific antigens or genetic modifications, which are technically demanding and expensive. Their intrinsic cytotoxicity, along with the possibility of allogeneic utilization (from healthy donors), provides access to the availability of mass producible, inexpensive therapies. The majority of clinical research and development to date has been in hematological malignancies, where they have been especially promising. Yδ T cells are able to penetrate the bone marrow and other lymphoid organs and exert tumor effects there through cytokine release, direct cytotoxicity, and changing the microenvironment of the tumor.
The demand for novel cancer therapies is pressing, especially in blood cancers like acute myeloid leukemia (AML), which tend to relapse or are resistant to conventional therapies. Options for patients who relapse following remission or who have residual disease (MRD) are limited, and prognosis is usually poor. Yδ T cell therapies are in a unique position to bridge this gap, providing a potentially effective, safe, and off-the-shelf product that can be delivered without the logistical issues of autologous T cell therapies, including manufacturing hold-ups or patient variability.
TC Biopharm is leading the way in clinical development in this area. The company's most advanced product candidate, OmnImmune (formerly TCB-002), is in a pivotal Phase 2/3 trial for AML. OmnImmune is an allogeneic Yδ T cell therapy engineered to quickly target and destroy cancer cells while avoiding damage to normal tissue. This clinical program is one of the most advanced in the global Yδ T cell pipeline, highlighting TC Biopharm's growing leadership within the domain. Besides OmnImmune, the company has a number of other Yδ T cell candidates in development for various cancer indications.
One of the most significant recent advances from TC Biopharm is the development of its candidate TCB008, which is under investigation in the Phase 2 ACHIEVE trial. The firm reported in June 2025 that the first patient in Cohort B, who had relapsed previously with detectable MRD, reached complete molecular remission following two doses. A lack of detectable NPM1 transcripts after treatment signifies a profound and lasting response, which identifies TCB008 as a promising post-remission therapy for blood cancers. This achievement demarcates the potent, targeted immune function of Yδ T cells and substantiates their role as a new therapeutic strategy.
Globally, most of the research studies on Yδ T cells remains on hematologic malignancies, and there are fewer programs directed at solid tumors. This is partly a result of the more sophisticated microenvironments and the immune evasion mechanisms utilized by solid cancers. However, attempts are being made to apply Yδ T cell treatments to these more difficult contexts. Geographically, US-based players dominate the Yδ T cell therapy market, followed by increasing numbers of Chinese firms. These regions have made heavy investment in cell therapy facilities and technology, facilitating quicker translation from bench to bedside.
Moving forward, the prospects for Yδ T cell therapy are bright but will necessitate continued clinical validation, most importantly in solid tumors. With advances in manufacturing technologies and biomarker-driven strategies, the use of Yδ T cells may extend to more types of cancers. With leaders such as TC Biopharm at the forefront, the field is on track to provide life changing treatments for critical unmet needs in cancer domain.