CD5標靶治療藥的全球市場:市場趨勢，臨床試驗，技術平台，未來預測(2025年)

Global CD5 Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025

出版日期: 2025年06月01日 | 出版商:

KuicK Research | 英文 72 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄圖表

全球 CD5 標靶治療市場：市場趨勢、臨床試驗、技術平台、未來展望 (2025) 報告重點與發現

目前，CD5 標靶治療尚無商業化核准。
CD5 標靶治療的最高開發階段：II 期。
臨床試驗中的 CD5 標靶治療數量：少於 10 個。
按公司、國家、適應症和階段劃分的 CD5 標靶治療臨床試驗。
趨勢：全球 CD5 標靶治療市場發展趨勢。
CD5
靶向。
治療藥物開發技術與平台洞察。
報告內容：
CD5 標靶治療的模式與作用機轉。
機制研究。方法論

CD5標靶療法市場正在迅速發展，尤其是在針對血液系統惡性腫瘤的免疫腫瘤學領域。雖然PD-1和CTLA-4等經典免疫檢查點靶點在實體瘤領域已得到充分認可，但CD5並非傳統的免疫檢查點靶點，它存在於T細胞上，由於其獨特的潛在生物學特性而更具吸引力。 CD5在某些T細胞淋巴瘤和白血病中高表達，為現有治療途徑有限的癌症提供了一種頗具吸引力的治療途徑。 T細胞免疫生物學專業知識的不斷增長，加上復發或難治性血液系統惡性腫瘤治療手段的匱乏，使CD5成為眾人矚目的焦點。

CD5療法領域最令人振奮的最新進展是細胞療法，尤其是CAR-T和CAR-NK療法。其中，開發進展最快的是March Biosciences公司的自體CD5標靶CAR-T細胞療法MB-105。 MB-105 由貝勒醫學院研發，已取得初步成功，部分病患在 I 期臨床試驗中病情緩解長達 5 年。該療法利用 CD5 的快速降解動力學，保留了 T 細胞功能，並巧妙地避免了自相殘殺的問題。這項創新使 MB-105 獲得了 FDA 頒發的治療 CD5 陽性 T 細胞淋巴瘤的孤兒藥資格認定，並於 2025 年初進入 II 期臨床試驗。

March Biosciences 獲得了投資者和機構投資者的大力支持，這表明他們對 MB-105 的治療價值充滿信心。該公司在 2024 年底的 A 輪融資中籌集了 2,840 萬美元，並獲得了多項非稀釋性撥款，包括來自德州癌症預防與研究中心和 Investigation Ready 的撥款。如此雄厚的資金支持確保了 March Biosciences 能夠進行大規模生產並有效推進臨床開發。

其他標靶CD5的療法也在新計畫中取得進展。 Vittoria Biotherapeutics公司正在其平台上開發VIPER-101（Senza5 CART5），目前正在進行T細胞淋巴瘤的I期臨床試驗。同時，GC Cell公司已啟動其CAR-NK療法GCC2005的臨床試驗，該療法加入白細胞介素-15以增強NK細胞的持久性，而這正是NK細胞療法的典型缺點。這反映了CD5標靶策略從傳統T細胞標靶向NK細胞甚至YδT細胞的多元化發展，例如Curocell在AACR2025大會上展示的同種異體CD5 YδCAR-T候選藥物。

即使取得了這些進展，CD5標靶療法仍面臨重大課題。實體腫瘤仍然是極具課題性的疾病，抗藥性、脫靶毒性以及腫瘤微環境中的運輸限制等轉化障礙限制了CD5療法在血液疾病之外的推廣。此外，製造的複雜性、自體細胞療法的成本以及所需的專業設施構成了物流和財務障礙。由於安全問題、違規風險以及缺乏長期療效數據，早期臨床研發管線容易萎縮。

此外，CD5標靶療法的早期開發已探索了單株抗體和抗體-藥物偶聯物，但這些藥物尚未提供足夠的臨床價值以進入後期臨床試驗。雙特異性抗體也已投入使用，但由於細胞療法在治療侵襲性難治性T細胞白血病的多功能性和優越性，其在研發管線中更為普遍。

展望未來，CD5領域不僅在腫瘤學領域令人振奮，在自體免疫疾病和移植排斥反應領域也同樣令人振奮。 CD5 的免疫調節作用表明，結合或阻斷該受體的標靶療法可以控制免疫反應，而這些免疫反應不僅限於殺死癌細胞。此類應用仍處於臨床前或早期研究階段。

整體而言，CD5 標靶療法市場發展勢頭強勁，尤其關注 T 細胞惡性腫瘤。臨床表現、投資流和日益增長的科學認知正在為進一步發展鋪平道路。然而，在這些療法成為主流之前，必須克服科學、物流和監管方面的障礙。如果克服這些課題，CD5 療法有望開啟精準免疫療法的新時代。

Currently No Commercial Approval For Any CD5 Targeting Therapy
Highest Phase Of Development For CD5 Targeting Therapies: Phase-II
Number OF CD5 Targeting Therapies In Clinical Trials: <10
CD5 Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase
Global CD5 Targeting Therapies Market Development Trends Insight
Insight On CD5 Therapies Development Technologies & Platforms
CD5 Targeting Drug Modalities & Mechanisms Of Action
Research Methodology Included In Report

The CD5 targeting therapy market is quickly gaining momentum, becoming a viable player within the immune oncology space, especially for hematologic malignancies. While classical immune checkpoint targets like PD-1 or CTLA-4 have been established well within the solid tumor space, CD5 represents a less conventional immune checkpoint target that has become more appealing with its presence on T cells and the distinctive biology behind it. CD5 is highly expressed in some T-cell lymphomas and leukemias, providing an attractive therapeutic route in cancers with limited useful treatment routes. The expanding expertise in T-cell immunobiology, coupled with the lack of available treatments for relapsed or refractory hematologic malignancies, is placing CD5 firmly in the limelight.

Perhaps the most exciting recent development in the CD5 treatment landscape is cell based therapy, especially CAR-T and CAR-NK therapies. One of the most developed is MB-105, an autologous CD5-targeted CAR-T cell therapy by March Biosciences. Having been originated at Baylor College of Medicine, MB-105 has had initial success; significantly, one patient in a Phase 1 study was in remission for five years. This treatment ingeniously gets around the problem of fratricide by harnessing the rapid degradation kinetics of CD5 to maintain engineered T-cell function. This innovation facilitated MB-105 to progress to Phase 2 trials in the early part of 2025, after it received FDA orphan drug designation for the treatment of CD5 positive T-cell lymphoma.

March Biosciences has attracted significant investor and institutional backing, testament to the faith in the therapeutic value of MB-105. The firm raised US$ 28.4 Million in a Series A round in late 2024 and has been awarded several non-dilutive grants, including grants from the Cancer Prevention and Research Institute of Texas and ScaleReady. Such strong funding guarantees that March can manufacture at scale and pursue clinical development effectively.

Other therapeutics targeting CD5 are also making progress with new programs. Vittoria Biotherapeutics is developing VIPER-101 (Senza5 CART5) with its in-house platform, which is in Phase 1 trials for T-cell lymphomas. GC Cell, on the other hand, has initiated a trial for its CAR-NK therapy GCC2005, which incorporates interleukin-15 to enhance NK cell persistence, which is a typical drawback of NK cell-based therapies. This is part of a wider diversification in CD5-targeting strategies away from conventional T-cell targeting to NK and even Yδ T cells, as exemplified by Curocell's allogeneic CD5 Yδ CAR-T candidate that was presented at AACR 2025.

Even with these developments, CD5 targeting therapies are fraught with major challenges. Solid tumors continue to be a challenging landscape; translational barriers such as resistance in the tumor microenvironment, off target toxicity, and trafficking limitations have limited the extension of CD5 therapies beyond blood diseases. Additional complexities of manufacturing, autologous cell therapy cost, and required specialized facilities create logistical and financial impediments. Early stage clinical pipelines are susceptible to attrition based on issues of safety, risks of fratricide, and lack of extensive long term efficacy data.

Moreover, during initial development of CD5-targeted approaches, monoclonal antibodies and antibody drug conjugates were explored but have not provided sufficient clinical value to enter late phase trials. There are efforts on bispecific antibodies, but cell therapies are prevalent in the pipeline because they are versatile and outperform in curing aggressive, refractory T-cell leukemia.

A glance to the future is exciting with the CD5 space in oncology but also autoimmune diseases and transplant rejection. The immunomodulatory character of CD5 indicates that therapies targeted to bind or block this receptor would control immune responses not just limited to the killing of cancer cells. These applications remain preclinical or in early stage explorations.

As a whole, the CD5 targeting therapy market is building momentum with a strong emphasis on T-cell malignancies. Clinical achievement, investment flow, and increasing scientific understanding are paving the way for further development. However, the discipline needs to overcome scientific, logistical, and regulatory obstacles before these treatments enter mainstream. If these challenges are overcome, CD5 therapies have the potential to be a new era in precision immunotherapy.

1. Emergence Of CD5 Targeting Therapies

1.1 Overview
1.2 History & Development

2. CD5 As Therapeutic Target

2.1 Expression & Immune Functions
2.2 Rationale For Targeting CD5 In Therapy
2.3 CD5 As Prognostic Biomarker

3. Therapeutic Indications Involving CD5

3.1 Cancer
3.2 Autoimmune & Inflammatory Diseases
3.3 Transplantation & Graft Rejection

4. CD5 Targeting Drug Modalities & Mechanisms Of Action

4.1 Cell Therapies
4.2 Monoclonal Antibodies
4.3 Bispecific Antibodies
4.4 Drug Conjugates

5. CD5 Targeting Therapies Development Platform Technologies By Indication & Company

6. Global CD5 Targeting Therapies Clinical Trials Overview

6.1 By Company
6.2 By Country
6.3 By Indication
6.4 By Patient Segment
6.5 By Phase
6.6 By Orphan Drug Designation

7. Global CD5 Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase

7.1 Preclinical
7.2 Phase - 0
7.3 Phase - I
7.4 Phase - II

8. Global CD5 Targeting Therapy Market Outlook

8.1 Current Market Developments Trends
8.2 Future Commercialization Opportunities

9. Global CD5 Targeting Therapies Market Dynamics

9.1 Favorable Development Parameters
9.2 Development Restraints To Be Resolved

10. Competitive Landscape

10.1 Artiva Biotherapeutics
10.2 Curocell
10.3 Essen Biotech
10.4 GC Cell
10.5 iCell Gene Therapeutics
10.6 March Biosciences
10.7 Precision Biotech
10.8 Vittoria Biotherapeutics

簡介目錄圖表

List of Figures

Figure 1-1: CD5 As Immune Modulator In Cancer & Autoimmunity
Figure 1-2: Key Milestones In CD5 Research
Figure 2-1: Suggested Ligands For CD5
Figure 2-2: CD5 - Rationale For Targeting
Figure 2-3: Prognostic Potential Of CD5
Figure 3-1: CD5 Function In Cancer
Figure 3-2: MB-105-201 Phase 2 (NCT06534060) Study - Initiation & Completion Year
Figure 3-3: MAGENTA Phase 1 (NCT03081910) Study - Initiation & Completion Year
Figure 3-4: GCC2005A-P101 Phase 1 (NCT06699771) Study - Initiation & Completion Year
Figure 3-5: VIPER 101 Phase 1 (NCT06420089) Study - Initiation & Completion Year
Figure 3-6: CD5 Function In Autoimmune & Inflammatory Diseases
Figure 3-7: CD5 - Role In Disease Pathogenesis
Figure 3-8: CD5 - Dual Role In Transplantation
Figure 3-9: CD5 In Immune Modulation Post Transplant
Figure 4-1: CD5 Targeting Drug Modalities
Figure 4-2: CD5 Targeting Cell Therapy Strategies
Figure 4-3: Xencor - CD5 x TGFBR2 Bispecific Antibody
Figure 4-4: Evolution Of Drug Conjugates Targeting CD5
Figure 5-1: SENZA5 Platform - Key Features
Figure 5-2: Vittoria Biotherapeutics - SENZA5 Platform
Figure 5-3: Vittoria Biotherapeutics - Proprietary Manufacturing Process
Figure 5-4: cCAR Technology - Advantages
Figure 5-5: ATAK(TM) Platform - Key Characteristics
Figure 5-6: XmAb Platform - Key Focus
Figure 6-1: CD5 Targeting Therapies In Clinical Trials By Company (Number Of Therapies), 2025
Figure 6-2: CD5 Targeting Therapies In Clinical Trials By Country Number Of Therapies), 2025
Figure 6-3: CD5 Targeting Therapies In Clinical Trials By Indication Number Of Therapies), 2025
Figure 6-4: CD5 Targeting Therapies In Clinical Trials By Patient Segment Number Of Therapies), 2025
Figure 6-5: CD5 Targeting Therapies In Clinical Trials By Phase Number Of Therapies), 2025
Figure 6 6: CD5 Targeting Therapies In Clinical Trials By Orphan Drug Designation Number Of Therapies), 2025
Figure 8-1: Global CD5 Targeting Therapy Market - Future Opportunities
Figure 9-1: Global CD5 Targeting Therapy Market Favorable Development Parameters
Figure 9-2: Global CD5 Targeting Therapy Market - Challenges & Restraints