CD5标靶治疗药的全球市场:市场趋势，临床试验，技术平台，未来预测(2025年)

全球 CD5 标靶治疗市场：市场趋势、临床试验、技术平台、未来展望 (2025) 报告重点与发现

• 目前，CD5 标靶治疗尚无商业化核准。
• CD5 标靶治疗的最高开发阶段：II 期。
• 临床试验中的 CD5 标靶治疗数量：少于 10 个。
• 按公司、国家、适应症和阶段划分的 CD5 标靶治疗临床试验。
• 趋势：全球 CD5 标靶治疗市场发展趋势。
• CD5
• 靶向。
• 治疗药物开发技术与平台洞察。
• 报告内容：
• CD5 标靶治疗的模式与作用机转。
• 机制研究。方法论

CD5标靶疗法市场正在迅速发展，尤其是在针对血液系统恶性肿瘤的免疫肿瘤学领域。虽然PD-1和CTLA-4等经典免疫检查点靶点在实体瘤领域已得到充分认可，但CD5并非传统的免疫检查点靶点，它存在于T细胞上，由于其独特的潜在生物学特性而更具吸引力。 CD5在某些T细胞淋巴瘤和白血病中高表达，为现有治疗途径有限的癌症提供了一种颇具吸引力的治疗途径。 T细胞免疫生物学专业知识的不断增长，加上復发或难治性血液系统恶性肿瘤治疗手段的匮乏，使CD5成为众人瞩目的焦点。

CD5疗法领域最令人振奋的最新进展是细胞疗法，尤其是CAR-T和CAR-NK疗法。其中，开发进展最快的是March Biosciences公司的自体CD5标靶CAR-T细胞疗法MB-105。 MB-105 由贝勒医学院研发，已取得初步成功，部分病患在 I 期临床试验中病情缓解长达 5 年。该疗法利用 CD5 的快速降解动力学，保留了 T 细胞功能，并巧妙地避免了自相残杀的问题。这项创新使 MB-105 获得了 FDA 颁发的治疗 CD5 阳性 T 细胞淋巴瘤的孤儿药资格认定，并于 2025 年初进入 II 期临床试验。

March Biosciences 获得了投资者和机构投资者的大力支持，这表明他们对 MB-105 的治疗价值充满信心。该公司在 2024 年底的 A 轮融资中筹集了 2,840 万美元，并获得了多项非稀释性拨款，包括来自德州癌症预防与研究中心和 Investigation Ready 的拨款。如此雄厚的资金支持确保了 March Biosciences 能够进行大规模生产并有效推进临床开发。

其他标靶CD5的疗法也在新计画中取得进展。 Vittoria Biotherapeutics公司正在其平台上开发VIPER-101（Senza5 CART5），目前正在进行T细胞淋巴瘤的I期临床试验。同时，GC Cell公司已启动其CAR-NK疗法GCC2005的临床试验，该疗法加入白细胞介素-15以增强NK细胞的持久性，而这正是NK细胞疗法的典型缺点。这反映了CD5标靶策略从传统T细胞标靶向NK细胞甚至YδT细胞的多元化发展，例如Curocell在AACR2025大会上展示的同种异体CD5 YδCAR-T候选药物。

即使取得了这些进展，CD5标靶疗法仍面临重大课题。实体肿瘤仍然是极具课题性的疾病，抗药性、脱靶毒性以及肿瘤微环境中的运输限制等转化障碍限制了CD5疗法在血液疾病之外的推广。此外，製造的复杂性、自体细胞疗法的成本以及所需的专业设施构成了物流和财务障碍。由于安全问题、违规风险以及缺乏长期疗效数据，早期临床研发管线容易萎缩。

此外，CD5标靶疗法的早期开发已探索了单株抗体和抗体-药物偶联物，但这些药物尚未提供足够的临床价值以进入后期临床试验。双特异性抗体也已投入使用，但由于细胞疗法在治疗侵袭性难治性T细胞白血病的多功能性和优越性，其在研发管线中更为普遍。

展望未来，CD5领域不仅在肿瘤学领域令人振奋，在自体免疫疾病和移植排斥反应领域也同样令人振奋。 CD5 的免疫调节作用表明，结合或阻断该受体的标靶疗法可以控制免疫反应，而这些免疫反应不仅限于杀死癌细胞。此类应用仍处于临床前或早期研究阶段。

整体而言，CD5 标靶疗法市场发展势头强劲，尤其关注 T 细胞恶性肿瘤。临床表现、投资流和日益增长的科学认知正在为进一步发展铺平道路。然而，在这些疗法成为主流之前，必须克服科学、物流和监管方面的障碍。如果克服这些课题，CD5 疗法有望开启精准免疫疗法的新时代。

目录

第1章 CD5标靶治疗的出现

• 概要
• 历史与开发

第2章 治疗标的的CD5

• 表达与免疫功能
• 以 CD5 为标靶进行治疗的理论基础
• 预后生物标记的CD5

第3章 CD5相关的治疗适应

• 癌症
• 自体免疫疾病和发炎性疾病
• 移植和移植片排斥反应

第4章 CD5标靶药物的模式和作用机制

• 细胞疗法
• 单株抗体
• 双特异性抗体
• 药物复合体

第5章 CD5标靶治疗药开发平台技术(各适应症·各企业)

第6章 世界CD5标靶治疗的临床试验概要

• 各企业
• 各国
• 各适应症
• 患者各市场区隔
• 各相
• 按罕见疾病用医药品指定

第7章 CD5标靶治疗的临床试验相关世界的洞察(企业，国家，适应症，各相)

• 前临床
• 第0相
• 第一阶段
• 第二阶段

第8章 全球CD5标靶治疗市场展望

• 目前市场趋势
• 未来的商业化的机会

第9章 全球CD5标靶治疗市场动态

• 有利的开发参数
• 开发规定的解除

第10章 竞争情形

• Artiva Biotherapeutics
• Curocell
• Essen Biotech
• GC Cell
• iCell Gene Therapeutics
• March Biosciences
• Precision Biotech
• Vittoria Biotherapeutics

Global CD5 Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025 Report Highlights & Finding:

• 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.

Table of Contents

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

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

List of Tables

• Table 2-1: CD5 In Immune Regulation
• Table 3-1: CD5 Expression Pattern By Cancer