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市場調查報告書
商品編碼
1750227
癌症的γδT細胞療法的全球市場:市場趨勢,技術平台,臨床試驗預測(2031年)Global Gamma Delta T Cell Cancer Therapy Market Trends, Technology Platforms & Clinical Trials Outlook 2031 |
全球癌症的γδT細胞療市場趨勢,技術平台,臨床試驗預測(2031年)報告的結論
適應性γδT細胞 (Yδ)免疫療法是一種新型免疫療法,利用獨特的T細胞亞群來辨識並摧毀癌細胞。典型的αβ(aB)T細胞辨識由主要組織相容性複合體(MHC)分子呈現的抗原,而YδT細胞則以MHC非依賴的方式被壓力誘導的配體和磷酸化抗原活化。這使得它們能夠檢測並針對多種腫瘤,包括那些傳統免疫警戒機制未針對的腫瘤。 YδT細胞兼具先天免疫和適應性免疫的特性,並具有即時應答和免疫記憶的能力,使其成為現成的過繼細胞療法的理想候選者。
在癌症治療中,YδT細胞因其無需技術難度高且成本高昂的腫瘤特異性抗原或基因改造即可摧毀惡性細胞的潛力而備受關注。其固有的細胞毒性,加上可以使用同種異體細胞(來自健康捐贈者)的可能性,為大規模生產和廉價治療提供了途徑。迄今為止,大多數臨床研發都集中在血液系統惡性腫瘤領域,該領域前景廣闊。 Yδ T 細胞可以侵入骨髓和其他淋巴器官,並透過釋放細胞激素、直接細胞毒性和改變腫瘤微環境來影響腫瘤。
迫切需要新的癌症療法,尤其是像急性骨髓性白血病 (AML) 這樣的血液系統癌症,這類癌症容易復發或對常規療法產生抗藥性。對於緩解後復發或有殘留疾病 (MRD) 的患者,治療選擇有限,預後通常較差。 Yδ T 細胞療法具有獨特的優勢,可以填補這一空白,它提供了一種可能有效、安全且易於獲取的現成產品,並且不存在自體 T 細胞療法的後勤問題,例如生產暫停和患者個體差異。
TC Biopharm 在該領域的臨床開發中處於領先地位。該公司最先進的候選產品 OmnImmune(原名 TCB-002)目前正在進行針對急性髓性白血病 (AML) 的關鍵性 II/III 期臨床試驗。 OmnImmune 是一種同種異體 Yδ T 細胞療法,旨在快速靶向並摧毀癌細胞,同時避免對正常組織的損害。該臨床計畫是全球 Yδ T 細胞產品線中最先進的計畫之一,彰顯了 TC Biopharm 在該領域新興的領導地位。除了 OmnImmune,該公司還有多個 Yδ T 細胞候選藥物正在開發中,用於治療各種癌症。
TC Biopharm 近期最重要的進展之一是其 TCB008 候選藥物的開發,該藥物目前正在進行 II 期 ACHIEVE 試驗。 2025 年 6 月,該公司報告稱,B 組首例患者(先前復發且可檢測到微小殘留疾病 (MRD))在接受兩次給藥後實現了完全分子緩解 (CRT)。治療後檢測不到NPM1轉錄本顯示療效顯著且持久,展現了TCB008作為血液系統癌症緩解後治療的潛力。這項結果凸顯了YδT細胞強大的標靶免疫功能,並證明了其作為一種新型治療策略的作用。
在全球範圍內,大多數對YδT細胞的研究仍停留在血液系統惡性腫瘤領域,針對實體腫瘤的項目較少。部分原因是實體瘤利用更複雜的微環境和免疫逃脫機制。然而,人們正在嘗試將YδT細胞療法應用於這些更具課題性的治療環境。從地區來看,美國公司在YδT細胞療法市場佔據主導地位,其次是越來越多的中國公司。這些地區在細胞療法設施和技術方面投入了大量資金,促進了該療法從實驗室到臨床的快速轉變。
展望未來,YδT細胞療法前景光明,但其在實體腫瘤中的臨床驗證仍需持續。生產和生物標記驅動策略的進步有望將YδT細胞的應用擴展到更多癌症類型。在TC Biopharm等領導企業的引領下,該領域可望為腫瘤學領域尚未滿足的重大需求提供改變生命的治療方案。
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.