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1858511

全球人類白血球抗原(HLA)標靶治療，臨床試驗，治療方法，市場機會的洞察(2026年)

Global Human Leukocyte Antigen (HLA) Targeted Therapy, Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2026

出版日期: 2025年11月01日 | 出版商:

KuicK Research | 英文 120 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

全球人類白血球抗原 (HLA) 標靶療法、臨床試驗、治療方案及市場機會洞察 (2026) 研究結果及亮點

首個人類白血球抗原 (HLA) 標靶療法預計將於 2030 年前獲批
按公司、適應症和階段劃分的人類白血球抗原 (HLA) 標靶療法臨床試驗的全面洞察
正在進行臨床試驗的 HLA 標靶療法：超過 10 種
人類白血球抗原 (HLA) 標靶療法的適應症
HLA 標靶療法治療方案的洞察
競爭格局概覽

HLA標靶療法的需求及本報告的意義

免疫療法的進展凸顯了人類白血球抗原 (HLA) 系統在免疫辨識中的作用，它不再只是背景因素，而一些HLA分子本身已成為直接的治療標靶。隨著研究的深入，人們越來越需要策略指導，以了解如何設計、測試HLA標靶策略並將其轉化為臨床應用。

本報告旨在滿足這一日益增長的需求，為包括生物技術公司、投資者、醫療保健規劃者和監管機構在內的利益相關者提供關於新興的HLA靶向療法領域的真實世界見解。隨著許多候選化合物進入臨床試驗並接近轉化里程碑，了解科學現狀和發展方向對於做出明智的決策至關重要。

本報告包含的臨床試驗及臨床試驗洞察

透過監測全球範圍內涉及HLA分子標靶療法的當前和近期臨床試驗，可以追蹤HLA標靶治療計畫的趨勢。本報告詳細分析了按臨床試驗階段、疾病類型、HLA分子標靶以及申辦方/合作方所在地區劃分的研發管線。例如，近期研究表明，非經典分子HLA-G正在一項針對實體瘤的首次人類體外泌體遞送試驗中進行研究。此外，大阪大學的研究小組闡述如何針對HLA-DRB1治療異體造血幹細胞移植後復發的急性骨髓性白血病。

透過匯總這些項目，本報告使用戶能夠評估哪些HLA分子正在獲得關注，哪些疾病適應症正在被重點關注，主要申辦方是誰，以及地域覆蓋範圍和試驗強度如何影響該領域。

從事人類白血球抗原 (HLA) 標靶療法研發的主要公司

多家公司正在開發針對 HLA 分子的新型標靶療法平台。例如，Quell Therapeutics 正在開發 QEL-001，這是一種首創的抗原特異性 CAR-Treg 細胞療法，針對 HLA-A2，用於治療接受肝臟移植的 HLA-A2 不匹配患者，並促進免疫耐受性。同樣，第一三共株式會社 (Daiichi Sankyo) 正在開發 DS-2243a，這是一種針對 HLA-A*02 複合物的雙特異性 T 細胞銜接器，旨在引導細胞毒性 T 淋巴細胞殺傷 NY-ESO-1 陽性腫瘤細胞。這些圖示顯示瞭如何利用 HLA 分子開發針對癌症和移植的新型免疫療法，突顯了 HLA 在新型生物學計畫中的核心地位。

報告展望人類白血球抗原 (HLA) 標靶治療領域未來發展方向

展望未來，HLA 標靶治療領域正朝著幾個重要的策略方向發展。其中之一是拓寬 HLA 分子的研究範圍，從經典的 I 類等位基因擴展到非經典 HLA 分子，例如 HLA-G 和 HLA-DRB1，這些分子可能在惡性腫瘤中選擇性上調。最近的一項綜述表明，HLA-G 作為一種免疫抑制檢查點分子，具有作為目標和生物標記的雙重價值。另一個未來發展方向是將診斷、病患分層和 HLA 表現譜分析整合到早期研發階段，以確保治療能精準地針對合適的病患群體。

整體而言，市場似乎正朝著模組化平台發展，這些平台可重複利用框架，針對多種適應症（包括細胞療法、雙特異性抗體和基於外泌體的遞送系統）靶向 HLA 分子。透過描繪這一發展軌跡，本報告旨在幫助讀者預測該領域的未來走向、投資和合作機會，以及 HLA 標靶治療市場未來的發展趨勢。

First Human Leukocyte Antigen (HLA) Targeted Therapy Approval Expected By 2030
Comprehensive Insight On Human Leukocyte Antigen (HLA) Targeted Therapies Clinical Trials By Company, Indication & Phase
Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials: > 10 Therapies
Therapeutic Indications For Human Leukocyte Antigen (HLA) Targeted Therapy
Insight On Human Leukocyte Antigen (HLA) Targeted Therapy Approaches
Competitive Landscape

Human Leukocyte Antigen (HLA) Targeted Therapy Need & Why This Report?

Advances in immunotherapy have highlighted the role of the human leukocyte antigen (HLA) system beyond that of a background component of immune recognition: some HLA molecules themselves are becoming direct therapeutic targets. As investigation moves forward, there is an increasing demand for strategic guidance on how HLA directed strategies can be formulated, tested and steered toward clinical application.

This report seeks to serve that growing demand by providing stakeholders, such as biotech companies, investors, healthcare planners and regulators, with real world insight into the emerging HLA targeted therapy space. With many candidates now reaching trials and approaching translational milestones, current understanding of where the science is and where the space is going is needed for informed decision making.

Clinical Studies & Trials Insight Included In Report

The development of HLA targeted therapy programs can be tracked by monitoring current and recent trials worldwide involving HLA molecule approaches. The report includes a detailed analysis of the development pipeline by trial stage, disease type, HLA molecule target and sponsor/collaborator geography. For instance, recent studies have indicated that the non-classical molecule HLA G is being investigated in a first in human exosome delivery study in solid tumors. In a further example, a research group at Osaka University explained how HLA DRB1 can be a target in relapsed acute myeloid leukaemia following allogeneic stem cell transplantation.

By aggregating such programmes, the report provides users with the capacity to measure which HLA molecules are gaining momentum, what disease indications are being focused on, who the lead sponsors are, and how geographic spread and trial intensity are influencing the field.

Leading Companies Engaged In R&D Of Human Leukocyte Antigen (HLA) Targeted Therapy

Multiple companies are working on platforms targeting HLA molecules in novel approaches. For example, Quell Therapeutics is progressing with QEL-001, a first-in-class antigen-specific CAR-Treg cell therapy targeting HLA-A2 to treat HLA-A2 mismatched patients undergoing liver transplantation, promoting immune tolerance. Likewise, Daiichi Sankyo is in the process of developing DS-2243a, a bispecific T-cell engager against the HLA-A*02 complex, designed to redirect cytotoxic T lymphocytes to kill NY-ESO-1-positive tumor cells. These illustrations point out the way HLA molecules are being used to develop new immunotherapies for cancer and transplantation, demonstrating their central position in novel biologic programs.

Report Indicating Future Direction Of Human Leukocyte Antigen (HLA) Targeted Therapy Segment

Looking ahead, the HLA targeted therapy segment is moving toward several key strategic orientations. One direction is broadening the spectrum of HLA molecules under investigation-moving beyond classical class I alleles toward non classical HLA molecules such as HLA G or HLA DRB1 that may be selectively up regulated in malignancy. Insights from recent reviews suggest that HLA G, as an immunosuppressive checkpoint molecule, offers dual value as both a target and a biomarker. Another future direction lies in integrating diagnostics, patient stratification and HLA expression profiling into early development so that therapies reach the right patient populations with precision.

Overall, the market appears to be gravitating toward modular platforms, be they cell therapies, bispecific antibodies, exosome based delivery systems, that reuse HLA molecule targeting frameworks across multiple indications. By mapping these trajectories, this report assists readers in anticipating where the field is headed, where investment or collaboration opportunities may lie, and how the HLA targeted therapy market may evolve in the coming years.

1. Introduction To Human Leukocyte Antigen (HLA) Targeted Therapy

1.1 Overview
1.2 History, Emergence & Development

2. Human Leukocyte Antigen (HLA) System Overview

2.1 HLA Structure & Function
2.2 Role Of HLA In Immune Response
2.3 Relevance To Targeted Therapies

3. Therapeutic Indications For Human Leukocyte Antigen (HLA) Targeted Therapy

3.1 Cancer
- 3.1.1 Solid Tumors
- 3.1.2 Hematologic Cancers
3.2 Organ Transplantation
3.3 Infectious Diseases
3.4 Autoimmune Diseases
3.5 Other Indications

4. Human Leukocyte Antigen (HLA) Targeted Therapy Approaches

4.1 Antibody Based Therapies
4.2 Cell Based Therapies
4.3 Gene Editing & Gene Therapy
4.4 Small Molecule Inhibitors
4.5 Peptide Based Therapies
4.6 Other Novel Approaches

5. Human Leukocyte Antigen (HLA) Genomics & Precision Medicine

5.1 HLA Typing & Screening
5.2 Personalized Medicine & Biomarker Discovery
5.3 Companion Diagnostics For HLA-Targeted Therapy

6. Global Human Leukocyte Antigen (HLA) Clinical Trials Overview

6.1 By Company
6.2 By Country
6.3 By Indication
6.4 By Phase

7. Global Human Leukocyte Antigen (HLA) Targeted Therapies Clinical Trials By Company, Indication & Phase

7.1 Research
7.2 Preclinical
7.3 Phase I
7.4 Phase I/II
7.5 Phase II
7.6 Phase III

8. Global Human Leukocyte Antigen (HLA) Market Analysis

8.1 Current Market Scenario
8.2 Future Market Opportunities

9. Global Human Leukocyte Antigen (HLA) Market Dynamics

9.1 Drivers & Opportunities
9.2 Challenges & Solutions

10. Competitive Landscape

10.1 BlueSphere Bio
10.2 Diamyd Medical
10.3 Grey Wolf Therapeutics
10.4 IMBiologics
10.5 Invectys
10.6 Quell Therapeutics
10.7 Rheumagen
10.8 Sangamo Therapeutics
10.9 Tizona Therapeutics
10.10 TScan Therapeutics

簡介目錄圖表

List of Figures

Figure 1-1: Human Leukocyte Antigen (HLA) System & Immune Activation
Figure 1-2: Managing Risks In HLA Targeted Therapy
Figure 1-3: Evolution Of HLA Research & Therapies
Figure 1-4: Development Of HLA Targeted Therapies
Figure 2-1: HLA System & Its Role In Immune Response
Figure 2-2: HLA Classes I, II, & III
Figure 2-3: Antigen Presentation via HLA Class I Molecules
Figure 2-4: Antigen Presentation via HLA Class I Molecules
Figure 2-5: HLA Polymorphism
Figure 2-6: HLA - Key Themes By Indication
Figure 2-7: HLA In Personalized Medicine
Figure 3-1: HLA Targeted Therapy To Enhance Cancer Immunity
Figure 3-2: SCOPE Phase 2 (NCT04079166) Study - Initiation & Completion Year
Figure 3-3: DENALI-1 Phase 1/2 (NCT06682793) Study - Initiation & Completion Year
Figure 3-4: SOB100-CL-Proto-01 Phase 1 (NCT07219940) Study - Initiation & Completion Year
Figure 3-5: AFNT-211 Phase 1 (NCT06105021) Study - Initiation & Completion Year
Figure 3-6: TSCAN-001 Phase 1 (NCT05473910) Study - Initiation & Completion Year
Figure 3-7: BSB1001-CL-101 Phase 1/2 (NCT06704152) Study - Initiation & Completion Year
Figure 3-8: HLA Targeted Transplant Therapies - Treg Gene Editing
Figure 3-9: HLA Sensitization In Transplantation
Figure 3-10: QEL-001-CLN-01 Phase 1/2 (NCT05234190) Study - Initiation & Completion Year
Figure 3-11: AOTCRI-102 Phase 1/2 (NCT07053488) Study - Initiation & Completion Year
Figure 3-12: HLA & Immune Evasion By Microbes
Figure 3-13: Modulating HLA For Autoimmune Disease Treatment
Figure 3-14: HLA Modulation In Immune Diseases
Figure 4-1: HLA Targeting Antibody Mechanisms
Figure 4-2: HLA Targeted Cell Therapies - Mechanisms & Applications
Figure 4-3: Off-the-Shelf & Universal HLA Directed Cell Therapies
Figure 4-4: Peptide Based HLA Targeted Therapy - Mechanism
Figure 4-5: Peptide Based HLA Therapy - Benefits
Figure 4-6: Novel HLA Targeted Therapy Platforms
Figure 5-1: HLA Typing -Technological Evolution
Figure 5-2: Challenges In HLA Typing & Clinical Integration
Figure 5-3: HLA - Role In Personalized Medicine
Figure 5-4: Immunopeptidomics - Role In Personalized Therapy
Figure 5-5: Companion Diagnostics Workflow
Figure 6-1: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Company, 2025 -2026
Figure 6-2: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Country, 2025 -2026
Figure 6-3: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Indication, 2025 -2026
Figure 6-4: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Phase, 2025 -2026
Figure 8-1: Global Human Leukocyte Antigen (HLA) Market - Future Opportunities
Figure 9-1: Global Human Leukocyte Antigen (HLA) Market - Drivers & Opportunities
Figure 9-2: Global Human Leukocyte Antigen (HLA) Market - Challenges & Solutions