VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.

This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).

开始日期2011-08-01

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT01147393

/ Terminated临床1/2期IIT

Phase I/II Study of Combination Veltuzumab (Anti-CD20) and Fractionated 90Y- Epratuzumab (Anti-CD22) Radioimmunotherapy in Patients With Follicular Lymphoma

A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials.
The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.

开始日期2010-10-01

申办/合作机构

Weill Medical College of Cornell University

[+1]

NCT01101581

/ Withdrawn临床1/2期

Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.

开始日期2010-05-01

申办/合作机构

Gilead Sciences, Inc.

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100 项与维妥珠单抗相关的专利（医药）

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项与维妥珠单抗相关的文献（医药）

2026-08-01·Neurology and Therapy

Safety and Efficacy of Obinutuzumab β (MIL62), a Novel Glycoengineered Type II Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorder: A Multicenter, Single-Arm, Phase Ib Clinical Trial

Article

作者: Liu, Sijun ; Liu, Ran ; Huang, Dehui ; Zhang, Hua ; Wu, Lei ; Xiang, Feng ; Wei, Min ; Gao, Feng ; Guo, Yanjun ; Liu, Xifang ; Yin, Jian ; Liang, Jinjin ; Gao, Sai ; Li, Feng ; Wang, Jiawei

INTRODUCTION:

To evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of obinutuzumab β, a novel glycoengineered type II anti-CD20 monoclonal antibody, in patients with neuromyelitis optica spectrum disorder (NMOSD).

METHODS:

In this multicenter, open-label, single-arm, phase Ib trial (NCT05314010), 11 aquaporin protein-4 (AQP4)-IgG-positive patients with NMOSD received obinutuzumab β at 500 mg or 1000 mg on days 1 of weeks 1 and 3. Patients in the 500-mg group could escalate to 1000 mg after 24 weeks if tolerated. Evaluations occurred at specified weeks (24-208), with 1000-mg doses on days 1 of weeks 25, 27, and every 26 weeks thereafter in patients who are relapse-free. Safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity were assessed.

RESULTS:

All participants with 500 mg (n = 3) transitioned to 1000 mg after 24 weeks. During the entire study period, all 11 participants experienced at least one treatment-emergent adverse event (TEAE); 90.9% had treatment-related adverse events (TRAEs). Serious adverse events were reported in 54.5%, with 27.3% related to obinutuzumab β. No TEAEs or TRAEs led to treatment discontinuation, withdrawal, or death. Two patients had early relapses on days 26 and 27 post-first dose, respectively; one withdrew immediately, while the other remained on treatment for 1 year. The 2-year disease relapse-free rate was 81.8% [95% confidence interval (CI): 44.7%, 95.1%], and the annualized relapse rate (ARR) declined from 1.3 before 2-year treatment to 0.2 (95% CI: 0.1, 0.2) after obinutuzumab β, representing an 87.7% reduction.

CONCLUSION:

Obinutuzumab β demonstrated manageable safety and may have promising efficacy against NMOSD. Despite the lack of a comparator group, the results support evaluation in phase III trials.

CLINICAL TRIAL REGISTRATION:

https://clinicaltrials.gov/ (#NCT05314010).

2026-08-01·Neurology and Therapy

Real-World Effectiveness and Safety of Ofatumumab: Analysis of B Cell Depletion, Comorbidities and Ethnicity in a Spanish Cohort

Article

作者: Ruiz-Escribano-Menchen, Lourdes ; Polache-Vengud, Josefa ; Lobato-Martinez, Ester ; Sempere, Angel P ; Moreno-Navarro, Luis

INTRODUCTION:

Ofatumumab, an anti-CD20 monoclonal antibody, is a high-efficacy disease-modifying therapy for relapsing multiple sclerosis (RMS). Although pivotal trials demonstrated substantial benefits, real-world data are required to confirm treatment persistence, effectiveness, safety, and biological markers of response in routine clinical settings. This study evaluated the real-world outcomes of ofatumumab in patients treated at a specialised multiple sclerosis (MS) centre in southeastern Spain, including exploratory analyses of B cell kinetics, comorbidity burden using the Charlson Comorbidity Index (CCI), and ethnicity.

METHODS:

A retrospective observational study was conducted in adults with MS initiating ofatumumab between December 2022 and December 2025, with ≥ 6 months of continuous therapy. Demographic, clinical, radiological, laboratory, and pharmacological data were extracted from electronic medical records. Statistical analyses encompassed Kaplan-Meier estimates.

RESULTS:

Eighty-seven patients were included (mean age 43 years; 75.9% female; 88.5% relapsing-remitting phenotype). Over a median 22-month follow-up, treatment persistence was 95.4%. Annualised relapse rate (ARR) declined from 0.48 pre-treatment to 0.03 on treatment. No evidence of disease activity (NEDA-3) was achieved in 93.1%, with no significant differences between treatment-naïve and previously treated patients. Sustained CD19⁺ B cell depletion was confirmed in all assessments. Immunoglobulin levels remained mostly stable. Ofatumumab was generally well tolerated: systemic injection-related reactions occurred in 29.9% and infections in 6.9%. Exploratory analyses showed no significant differences in relapse or magnetic resonance imaging outcomes by CCI category or ethnicity.

CONCLUSION:

In this Spanish real-world single-centre cohort, ofatumumab demonstrated high persistence, substantial suppression of inflammatory activity, and a favourable safety profile in routine clinical practice. Sustained B cell depletion aligned with clinical and radiological stability. These findings support the real-world effectiveness of ofatumumab across diverse patient profiles and complement evidence from pivotal trials. Further prospective studies with broader populations and longer follow-up are warranted to refine understanding of long-term outcomes and determinants of treatment response variability.

2026-07-03·JOURNAL OF PROTEOME RESEARCH

Reduction-Free Thermolysin Digestion Enables Absolute Protein Quantitation in Plasma in 35 min from Sample to Result

Article

作者: Zahedi, René P. ; Jiang, Xuehui ; Lao, Ying ; Banerji, Versha ; Johnston, James B.

We previously reported that the broad-specificity protease thermolysin yields reproducible, near-complete proteome digests within 1-2 min. Here, we demonstrate rapid absolute protein quantitation in human plasma by combining reduction/alkylation-free thermolysin digestion on S-Trap cartridges with full-length stable isotope-labeled (SIL) protein standards and parallel reaction monitoring (PRM). Post-digest dilution of S-Trap eluates enabled immediate EvoTip loading, yielding LC-MS-ready samples in under 20 min. Using the anti-CD20 monoclonal antibody rituximab as a showcase, a lower limit of quantitation of 5 amol on-column per ∼250 ng plasma protein injection could be achieved on an Orbitrap Exploris 480 in 60/100 samples-per-day mode. We applied the assay to 23 total pretreatment and on-treatment plasma samples from 12 chronic lymphocytic leukemia patients, demonstrating fit-for-purpose absolute quantitation in a clinical matrix. In 100 samples-per-day mode, the full workflow enables on-demand absolute protein quantitation in 35 min from sample to fully acquired LC-MS data. The achieved sensitivity indicates the feasibility of transfer to other targets or matrices with lower concentrations. Because the required SIL proteins are used at femtomole levels (here, 40 fmol of SIL rituximab spiked into 10 μg of plasma protein), a single 10-μg SIL IgG vial is sufficient as internal standard for ∼1700 injections.

项与维妥珠单抗相关的新闻（医药）

2026-07-14

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2026年7月8日-7月14日医美为主文献汇总（每日文献）

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Injection to Balance Eyebrows and Facial Shapes: A Review with Illustrative Clinical Examples 78.Three-dimensional three-interval thixotropy test (3D-3ITT) protocol for cosmetic lotions: A proof-of-concept study linking thixotropy to sensory and emotional responses 79.Bridging the gap between consumer perception and objective measurements: A novel multiview image analysis methodology for quantifying hair volume on a human head (curl type I to III) 80.Real-world evidence for the efficacy and tolerability of an isobutylamido-thiazolyl-resorcinol (Thiamidol)-containing skincare regimen on facial hyperpigmentation and overall skin appearance: A multi-centre study in 11 European countries 81.A Possible Role of Mycobiome in the Pathophysiology of Acne: Structured Narrative Review and Perspectives 82.MFAP4 Promotes Scar Formation by Regulating Macrophage-Myofibroblast Transformation Through Activation of the TGF-β/Smad3 Signalling Pathway 83.Polynucleotides and Polydeoxyribonucleotides for Skin Rejuvenation, Postoperative Scar Prevention, and Wound Healing: A Systematic Review of Randomized Clinical Trials 84.First Case Series on Ambulatorial Endoscopic Sleeve Gastroplasty for Morbidity Obesity: A Single Center Experience 85.Short-Term Clinical and Metabolic Outcomes of Laparoscopic Sleeve Gastrectomy in Korean Adolescents with Severe Obesity: A Retrospective Analysis 86.Neural Decision-Making and Affective Dynamics in Weight Regain after Metabolic and Bariatric Surgery: A Multimodal Longitudinal Computational Psychiatry Study 87.Beyond Initial Resolution: Predictors of Recurrence of Obesity-related Medical Conditions after Metabolic and Bariatric Surgery 88.Fractional CO2 Laser in Lichen Amyloidosis With Rapid Pruritus Resolution and Long-Term Remission: Serial PGP9.5 and Dylon Observations With Touch Sensitivity Assessment 89.Integrated single-cell and spatial transcriptomic analyses reveal an aging-associated fibroblast subtype linked to tumor progression in human skin 90.Microcore Skin Biopsies: A Novel, Micro-Invasive Skin Biopsy Technique Yielding Full-Thickness Histology 91.Topical Melatonin in Aesthetic Dermatology: From Cutaneous Melatoninergic Biology to Photoprotection, and Skin Rejuvenation 92.Fast-tracking dermatologic care for “VIP” patients: ethical concerns and practical approaches 93.Acneiform Eruption with Deucravacitinib: Systematic Review and Meta-Analysis 94.Topical Hypochlorous Acid for Acne Vulgaris: Mechanisms, Clinical Evidence, and Therapeutic Potential 95.Equity Evaluation: Analysis of the Prescribing Patterns of Isotretinoin Based on Reproductive Potential 96.Rosacea: We Still Haven’t Found What We’re Looking For 1. 鼻整形术对性生活活跃已婚女性性功能、自尊及抑郁症状的影响（更正） 2. 评《评估大语言模型生成医疗文书的效能：ChatGPT-4、ChatGPT-4o与Claude的比较研究》 3. 无脱细胞真皮基质及补片的胸前乳房重建：呼吁比较性证据 4. 皮内注射10%葡萄糖（Sihler G）用于头皮毛发再生：一项随机、评估者设盲的预试验研究 5. 肌内臀部填充的技术演进：15年队列、5081例手术及高级臀部塑形术（MAG）的创立 6. A型肉毒毒素注射后骨骼肌的细胞重塑：一项单核RNA测序研究 7. A型肉毒毒素：迷思、证据与全球媒体叙事 8. 激光、微针及联合疗法治疗中重度萎缩性痤疮瘢痕：一项系统综述与网状Meta分析 9. 肌肉作为眉间肉毒毒素注射的基本治疗单元：技术描述与初步临床经验 10. A型肉毒毒素通过抑制TGF-β1/Smad通路减轻兔耳模型增生性瘢痕形成（更正） 11. 致编辑的信回复：《肌内效贴作为外部机械疗法：将其作用从乳腺手术拓展至身体塑形》 12. 评《肋软骨切取的新理念以减轻供区术后疼痛》 13. 单瓣耳廓重建中的新型耳上切口：一项回顾性研究 14. 先天性单睑与重睑的睑板前纤维脂肪筋膜层：一项尸体、组织学及超声研究 15. 面部自体脂肪移植后脂肪坏死：已报道并发症及处理策略的系统综述 16. 血管紧张素Ⅱ作为烧伤后增生性瘢痕评估与预测的新型生物标志物：一项倾向评分匹配队列研究 17. 美容外科领域医患信任多维测量量表的构建方案 18. CO₂激光消融术与锥切术治疗宫颈上皮内瘤变2级：一项前瞻性队列研究 19. 点阵微针射频治疗光老化及萎缩性痤疮瘢痕：两种设备的半脸临床观察 20. 强脉冲光（IPL）、脉冲染料激光（PDL）与Q开关掺钕钇铝石榴石（Nd:YAG）激光治疗中重度炎症性痤疮的疗效与安全性比较：一项三臂随机对照临床试验 21. 保留皮肤清创联合负压滴注滞留伤口治疗早期坏死性筋膜炎 22. 90度叶旋转的岛状双叶皮瓣修复基底细胞癌切除后鼻尖缺损 23. 超微血管成像增强淋巴超声用于淋巴水肿相关淋巴管静脉吻合术前定位 24. 腹壁下深动脉穿支皮瓣乳房重建联合血管化淋巴结移植及腹壁整形的一体化显微外科康复 25. 背阔肌皮瓣治疗放射性胸壁溃疡 26. 神经源性胸廓出口减压术中采用再生性周围神经界面处理锁骨上神经横断 27. 照亮黑暗：吲哚青绿血管造影评估晚期动静脉环血栓后游离皮瓣自主血运重建 28. 负压伤口治疗调节铜绿假单胞菌感染猪伤口的pH值及细菌侵袭 29. DIEP皮瓣重建中双穿支的血流动力学优势 30. 解读至关重要：回顾性外科研究中的常见统计学陷阱 31. 为整形外科医生构建实用人工智能工具：Cowork分步指南 32. 患者对透明质酸填充剂的认知误区：基于经验的思考 33. 鼻整形术后镜像对峙困扰：患者报告结局测量工具的开发与验证 34. 稀释型羟基磷灰石钙羧甲基纤维素（Radiesse）治疗颈胸区皱纹：成年女性的安全性与有效性 35. 整形外科中的人工智能：100篇最高被引英文出版物的文献计量学与可视化分析 36. 乳房植入物及肋骨骨髓炎中的偶发分枝杆菌感染：一例病例报告及文献复习 37. 超稀释羟基磷灰石钙注射联合点阵微针射频改善膨胀纹：一项预试验研究 38. 一次手术、多根神经、多样疼痛表型：面部透明质酸注射后三叉神经病理性疼痛四例病例系列 39. 采用预修剪法的非剃发毛囊单位提取及大剂量毛发移植：巴西外科团队经验 40. 乳蛋白水解物对自觉皮肤暗沉女性皮肤质量及晚期糖基化终末产物的影响：两项为期8周的随机对照试验 41. 蜂蜜作为化妆品配方中保湿成分的功效：临床试验的系统综述 42. 面部美容外科中的光生物调节疗法：疗效与安全性的系统综述 43. 化学剥脱术在色素性皮肤病治疗中的应用进展 44. Q开关Nd:YAG激光去除艺术性及美容性纹身 45. 损伤病因与瘢痕结局的关联：一项回顾性临床研究 46. 上面部皱纹神经毒素注射时机 47. 大剂量多通道射频治疗对内脏及皮下腹部脂肪的影响：一项干预前后研究 48. 化妆品使用及其潜在风险：印度旁遮普地区公众认知与态度评估 49. 外用曲法罗汀治疗马来西亚寻常痤疮的疗效与耐受性：一项单臂、开放标签、观察性研究 50. 多核苷酸注射后面部双侧革兰阴性脓肿 51. 双平面生物刺激剂注射中的平面-厚度等分匹配探讨 52. 羟基磷灰石钙用于中国人群颞部轮廓修复的临床及三维评估 53. 采用尖端超声技术研究安全填充剂注射技术 54. 神经美学应用于美容医学的概念与披露考量 55. 植入物相关ASIA及乳房植入物疾病中的全身症状模式：一项研究水平描述性系统综述 56. 寻常痤疮中的睡眠-压力-皮肤轴 57. 采用高能量密度1064nm皮秒激光的统一黄金参数疗法无副作用去除纹身 58. 含补骨脂酚与水杨酸的护肤霜治疗轻中度寻常痤疮的疗效与安全性：一项非劣效性随机对照试验 59. 外用山椒素衍生制剂治疗黄褐斑的疗效与安全性：一项随机、双盲、安慰剂对照试验 60. 评射频微针与点阵二氧化碳激光治疗面部萎缩性痤疮瘢痕的疗效、恢复及色素安全性比较：一项前瞻性随机半脸试验 61. 证据合成中的人工智能：益处、局限及透明报告的重要性 62. 近红外血管定位引导浅表皮肤血管病变的操作处理 63. 儿科患者的中央离心性瘢痕性脱发：一项回顾性分析 64. 透明质酸、氨基酸与维生素的焕活复合物促进人体皮肤微循环 65. 90天护肤方案期间皮肤变化的仪器与患者报告评估：一项前瞻性单臂观察性研究 66. 澳大利亚人群BODY-Q模块常模数据及与北美、欧洲常模的比较 67. 便携式结构光三维容积测量用于乳房及皮瓣评估：技术验证与工作流程开发 68. 鼻唇沟皮瓣在鼻重建中的多样化应用：基于缺损的算法 69. 数字时代的患者教育：在线瘢痕疙瘩信息可读性、质量及可操作性评估 70. 脂溢性皮炎对健康相关生活质量的影响：一项质性分析 71. 硬斑病组织中聚集蛋白聚糖的表达：纤维化细胞外基质积聚的潜在促成因素 72. 亚洲患者异维A酸方案的疗效与安全性比较：一项系统综述与Meta分析 73. 采用在体反射式共聚焦显微镜表征不同瘢痕成熟阶段人体瘢痕组织中的胶原 74. 老年肥胖及2型糖尿病患者使用GLP-1受体激动剂的特殊考量 75. 频繁饮用含糖饮料与生物衰老加速相关：来自人群研究及肠道菌群分析的证据 76. 痉挛管理专科进修带来的高级肉毒神经毒素注射培训收益 77. IncobotulinumtoxinA注射平衡眉形与面型：附临床示例的综述 78. 化妆品乳液的三维三区间触变性测试（3D-3ITT）方案：触变性与感官及情绪反应关联的概念验证研究 79. 弥合消费者感知与客观测量之间的差距：一种量化人体头部发量的新型多视角图像分析方法（Ⅰ-Ⅲ型卷发） 80. 含异丁基酰胺基-噻唑基-间苯二酚（Thiamidol）护肤方案改善面部色素沉着及整体皮肤外观的真实世界证据：11个欧洲国家的多中心研究 81. 真菌组在痤疮病理生理学中的可能作用：结构化叙述综述与展望 82. MFAP4通过激活TGF-β/Smad3信号通路调控巨噬细胞-肌成纤维细胞转化促进瘢痕形成 83. 多核苷酸与聚脱氧核苷酸用于皮肤年轻化、术后瘢痕预防及伤口愈合：随机临床试验的系统综述 84. 门诊内镜下袖状胃成形术治疗病态肥胖的首批病例系列：单中心经验 85. 韩国重度肥胖青少年腹腔镜袖状胃切除术的短期临床与代谢结局：一项回顾性分析 86. 代谢与减重手术后体重反弹中的神经决策与情感动力学：一项多模态纵向计算精神病学研究 87. 超越初始缓解：代谢与减重手术后肥胖相关疾病复发的预测因素 88. 点阵CO₂激光治疗淀粉样变苔藓伴瘙痒快速缓解及长期缓解：PGP9.5与Dylon系列观察及触觉敏感性评估 89. 单细胞与空间转录组整合分析揭示与人体皮肤肿瘤进展相关的衰老相关成纤维细胞亚型 90. 微芯皮肤活检：一种可获取全层组织学的新型微创皮肤活检技术 91. 美容皮肤科中的外用褪黑素：从皮肤褪黑素能生物学到光防护及皮肤年轻化 92. "VIP"患者皮肤科快速通道诊疗：伦理考量与实践路径 93. 氘可来昔替尼所致痤疮样皮疹：系统综述与Meta分析 94. 外用次氯酸治疗寻常痤疮：机制、临床证据及治疗潜力 95. 公平性评估：基于生育潜力的异维A酸处方模式分析 96. 玫瑰痤疮：我们仍未找到真正的答案文献求助 1.Preserving the Modiolus: Enhanced Functional and Aesthetic Restoration with the Modified Bernard-Webster Technique in Lip Reconstruction（暂无） 2.Real-Time Integration of Patient-Reported Outcomes in Breast Cancer Surgery: Feasibility of the BREAST-Q REACT（暂无） 3.Why Plastic Surgery Must Rethink Residency Capacity 4.Seeing Clearly, Working Comfortably: 3D Exoscopes in Cleft Surgery Ergonomics and Education（暂无） 5.Exploring the Role of Fascia Lata Suspension in Triple Nerve Transfer for Facial Reanimation: A Comparative Outcomes Study 6.Vertical Superior Epigastric Artery Perforator Flap for Autologous Breast Augmentation After Massive Weight Loss（暂无） 7.The Impact of Nontobacco Nicotine Dependence on Postoperative Complications in Reconstructive and Aesthetic Breast Surgery Procedures: A Multicenter Propensity-Score Matched Analysis.（暂无） 8.Simultaneous 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30.Hexahedral Graft Bed Formation Enhances Outcomes in Secondary Alveolar Bone Grafting: Surgical Technique and Graft Volume Thresholds 31.Dorsal Width and Functional Outcomes with use of Autospreader Flaps in Cosmetic Rhinoplasty 32.Non-contrast Magnetic Resonance Angiography Versus Contrast-enhanced Computed Tomography in Deep Inferior Epigastric Perforator (DIEP) Flap Planning: A 4-year Non-inferiority Cohort Study 33.Clinical Evidence and Commercial Landscape of Topical Exosomes for Skin Rejuvenation: A Scoping Review 34.Subdomal Graft Control of Nasal Tip Aesthetics: A Long-term Digital Photographic Evaluation 35.Assessment of Skin Physiology Changes, Efficacy, and Safety of a New Complex Herbal Cream: A 4-Week Multi-Center, Open-Label, Prospective Study of Patients With Sensitive Skin and Rosacea 36.Lipedema or Advanced Cellulite? 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营养平衡式面部年轻化手术：传统除皱术的微创替代方案 82. 复合型乳房假体：279例新型乳房假体初步临床研究 83. 面部注射类制剂相关并发症：肉毒毒素与透明质酸 84. 淋巴水肿临床及手术治疗的适应症与预后效果研究综述 85. 当代脂肪抽吸术技术分化与创新：基于新型技术的术后恢复阶段深度研究 86. 第三代超声辅助高清脂肪抽吸术：术后疗效回顾性分析文献求助 1.Clinical Risk and Regulatory Oversight for Office-Based Cosmetic Procedures: A State-By-State Analysis 2.Poly-l -Lactic Acid Safety Over the Past 5-years: Analysis of US Food and Drug Administration Database Reports (2020–2025) 3.Periorbital Changes Following Glucagon-Like Peptide-1 Receptor Agonist Use: A Retrospective Cohort Study of Oculofacial Complications and Interventions 4.One-day rejuvenation: a preliminary case series of a multimodal protocol combining Q-switched 1064 nm laser, botulinum toxin, and laser-assisted delivery of PDRN and retinoids 5.A body-wide atlas for murine hair cycle dynamics 6.Microsurgical Anatomy and Surgical Relevance of the Internal Frontal Arteries: A Cadaveric Anatomic Study 7.In-vivo comparison of the neurotoxic potencies of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA 8.In silico multiscale computational modelling of botulinum toxin a diffusion for glabellar wrinkle treatment: Optimizing injection volumes across formulations 1. 诊室美容操作的临床风险与监管：各州分析 2. 聚左旋乳酸过去5年的安全性：美国食品药品监督管理局数据库报告分析（2020–2025） 3. 胰高血糖素样肽-1受体激动剂使用后的眶周变化：眼面部并发症与干预措施的回顾性队列研究 4. 一日焕颜：联合调Q 1064 nm激光、肉毒毒素及激光辅助递送PDRN与维A酸类药物的多模式方案初步病例系列 5. 小鼠毛发生长周期全身动态图谱 6. 额内侧动脉的显微外科解剖及其外科意义：尸体解剖学研究 7. incobotulinumtoxinA、onabotulinumtoxinA与abobotulinumtoxinA神经毒力的体内比较 8. 眉间纹治疗中A型肉毒毒素扩散的多尺度计算机模拟：不同制剂注射体积的优化 7月8日皮肤 1.斑秃患者血清Th1_Th2_Th17_Treg细胞因子的表达及其临床意义_吴恺悦.pdf 2.瘢痕形成的多轴耦合网络调控机制及工程化干预策略研究进展_沈非凡.pdf 3.M1_M2巨噬细胞外泌体通过特异性miRNA介导的信号通路调控瘢痕形成机制_余南生.pdf 4.火针联合光动力疗法对难治性痤疮皮损修复及瘢痕预防的疗效研究_钟维.pdf 5.胶原头皮护理精华液对雄激素性脱发小鼠毛发生长的影响_肖玲.pdf 6.从机制到靶点：皮肤光老化的表观遗传调控研究进展_潘洋.pdf 7.脂代谢异常与女性型脱发发生发展的相关性研究_廖钟敏.pdf 8.粪菌移植在皮肤科的应用前景-蔡志成赵阳陈韦君张玲杨桂兰.pdf 9.瘢痕疙瘩药物靶点预测：多组学孟德尔随机化分析-博文平罗银利赵蕾娜荷芽高翠丽崔艾丽金哲虎.pdf 10.长脉冲1064_nm_Nd__YAG激光联合2%盐酸卡替洛尔滴眼液外用治疗婴幼儿血管瘤疗效评价_孙丽娜.pdf 11.瘢痕疙瘩病灶局部注射操作专家共识-中国整形美容协会护理分会申琳李峰周勇.pdf 12.皮肤镜在基底细胞癌诊断及治疗中的应用-褚丹祝立丽李晓东赵佳宇韩阳.pdf 13.3种手术方式治疗儿童四肢中型先天性色素痣临床疗效观察_刘琪.pdf 14.皮肤镜检查在女性休止期脱发和女性雄激素性脱发诊断中的作用-房灵秦凤.pdf 15.微针疗法在黄褐斑中的应用进展-苏孟李海涛.pdf 16.大气压冷等离子体治疗轻中度痤疮临床研究_赵艳君.pdf 17.利特昔替尼治疗成人斑秃及儿童普秃2例_陈溪.pdf 18.皮肤创面多重耐药菌感染的菌群分布与耐药性分析-赵小丹宗岩周旋.pdf 19.基于蛋白质组学倍他米松联合染料激光治疗增生性瘢痕机制研究-隋诗佳吴佳敏刘旭葵王旭东杨佳曼夏志宽李海涛杨蓉娅.pdf 20.瘢痕疙瘩与特应性皮炎潜在关键共同生物标志物的筛选及白藜芦醇对瘢痕疙瘩成纤维细胞体外作用研究-刘家希王思慧丰叶琪布文博周炳荣鲁严.pdf 21.雄激素性秃发患者对不同配方米诺地尔制剂的斑贴试验结果分析-王英杨顶权.pdf 22.异维A酸治疗面部多发皮脂腺增生一例_潘伟军.pdf 23.光线性角化病132例临床分型与皮肤镜特征分析_薛月萃.pdf 24.点阵激光联合自体微颗粒脂肪移植修复面部痤疮瘢痕皮肤屏障的效果-林乐乐张亚男王锦慧.pdf 25.异维A酸软胶囊联合消痤面膜治疗中重度痤疮的临床疗效观察_李旭芳.pdf 26.基于数据挖掘、网络药理学和分子对接分析中药治疗雄激素性秃发的用药规律与机制_冯鹤.pdf 27.毛发再生的机制及临床转化研究进展_冯南飞.pdf 28.c-nu小鼠皮肤光老化蛋白组学分析-徐远飞唐伟龚春梅杨慧.pdf 29.《皮肤病家庭紫外线光疗规范》要点解读_胡煜.pdf 7月8日中国医疗美容 1.超脉冲二氧化碳激光祛除面部色素痣的临床效果及其影响因素探讨-郭学娜陈盼盼刘方真李艳.pdf 2.舒缓修复联合分级干预模式对痤疮敏感肌患者激光术后皮肤反应及满意度的影响分析_赖色玉.pdf 3.四关活血法针刺联合桃花灸治疗肝郁气滞兼血瘀型黄褐斑的疗效分析-杨璐康艳杨春海.pdf 4.两侧双切口脂肪抽吸联合大汗腺微创剪除术治疗腋臭的临床效果研究_王兆楠.pdf 5.水刀辅助小切口微创手术联合自制封闭负压引流技术在腋臭治疗中的应用_袁东亮.pdf 6.生长发育高峰期不同矢状骨面型高角患者颞下颌关节形态的CBCT研究_诸葛南山.pdf 7.富血小板血浆在瘢痕治疗中的进展-刘新宇陈宁杰张瑾王海涛.pdf 8.浅谈公立医院医疗美容主诊医师职业发展路径-本刊编辑部.pdf 9.颧部褐青色斑激光治疗后炎性色素沉着发生情况及其影响因素探讨_苏蕾.pdf 10.整形外科求美者体像障碍现状及与负性情绪的相关性研究_杨凯欣.pdf 11.A型肉毒毒素联合下睑皮肤入路法在松弛型眼袋修复中的应用效果_姜琰.pdf 12.颗粒脂肪联合纳米脂肪矫正重度鼻唇沟凹陷的临床研究_钟欣.pdf 13.基于多维评分系统的尿道下裂患儿术后并发症的风险预测模型的构建与验证_花鸣春.pdf 14.自拟活血通络方熏洗联合常规西药治疗糖尿病足溃疡的疗效观察_费驰媛.pdf 15.机器学习在骨性畸形横向特征识别中的应用研究_张吉利.pdf 16.下鼻甲体积和鼻中隔偏曲与颌面部发育的关系_刘佳.pdf 17.强脉冲光联合超脉冲二氧化碳点阵激光治疗面部皮肤光老化的临床效果-陈红方礼英吴岚英.pdf 18.强脉冲光联合超脉冲二氧化碳点阵激光预防面部外伤清创缝合术后早期瘢痕的临床疗效-闫美荣齐晓铭梁仁章张晓燕.pdf 7月8日创面修复 1.成人烧伤患者气道灌洗疗法专家共识（2026版）.pdf 2.足踝部复杂组织缺损的临床分型与显微重建策略.pdf 3.浅谈显微外科技术和游离穿支皮瓣修复创面.pdf 4.垂直褥式缝合联合水滴形动脉端侧吻合技术在游离皮瓣移植修复四肢创面中的临床应用效果.pdf 5.ALTF联合“Y”形大隐静脉移植修复小腿近中段大面积软组织缺损的临床效果.pdf 6.经真皮下入路切取旋髂浅动脉PSP皮瓣修复手足部皮肤软组织缺损的效果.pdf 7.大鼠骨髓间充质干细胞来源外泌体对高糖环境下大鼠Fb的影响及其机制.pdf 8.谷胱甘肽对小鼠皮肤急性光损伤的作用及其机制.pdf 9.大学生创伤后成长现状及其与创伤后应激症状之间的中介路径.pdf 10.线粒体动力学在糖尿病足溃疡中的作用机制及其相关干预策略研究进展.pdf 7月8日中华皮肤 1.抗p200类天疱疮诊断与治疗专家共识（2026版）.pdf 2.儿童肛门生殖器硬化性苔藓诊疗管理中国专家共识（2026版）.pdf 3.老年银屑病诊疗与康复专家共识（2026版）.pdf 4.毛发活检病理中国专家共识（2026版）.pdf 5.肠道菌群移植治疗银屑病专家共识（2026版）.pdf 6.反射式共聚焦显微镜联合皮肤镜对基底细胞癌的诊断价值评估.pdf 7.基于网络药理学与HaCaT细胞实验探讨茯苓及其活性成分茯苓酸对特应性皮炎相关炎症反应的作用及机制研究.pdf 8.经典型Ehlers-Danlos综合征1例COL5A1基因突变分析.pdf 9.乌帕替尼治疗6例掌跖脓疱病的临床疗效与安全性分析.pdf 10.度普利尤单抗治疗5例难治性内源性角化型手足部湿疹病例系列研究.pdf 11.家系环纹发1例.pdf 12.阿达木单抗治疗难治性青斑样血管病2例.pdf 13.新生儿吸吮性水疱1例.pdf 14.生物制剂治疗银屑病与特应性皮炎后出现免疫漂移：临床特征、机制与治疗策略.pdf 15.温泉疗法在皮肤病中的研究进展.pdf 7月8日中华整形 1.预扩张远位皮瓣在儿童上肢大面积皮肤缺损修复中的应用效果.pdf 2.高频彩色多普勒超声辅助设计带感觉神经的游离分叶股前外侧穿支皮瓣修复手足复杂创面.pdf 3._锚钉_式腱骨重建治疗指伸肌腱止点撕脱伤的效果观察.pdf 4.M形接力皮瓣修复儿童手指屈曲畸形松解后皮肤缺损的临床效果.pdf 5.游离股前外侧皮瓣修复手部严重瘢痕挛缩畸形效果观察.pdf 6.躯体变形障碍在鼻整形求美者与非鼻整形人群中的对比：一项横断面研究.pdf 7.耳部自体组织移植在后天性耳廓部分缺损修复中的临床应用.pdf 8.聚左旋乳酸注射填充治疗鼻唇沟凹陷的安全性及有效性研究.pdf 9.人参皂苷Rg3经IGF2BP2_HK2轴调控糖代谢抑制皮肤鳞状细胞癌机制研究.pdf 10.瘢痕疙瘩体外模型研究现状.pdf 11.皮肤下软组织扩张器的应用.pdf 12.昼夜节律紊乱与难愈性创面：聚焦皮肤屏障功能和免疫稳态.pdf 13.中药在增生性瘢痕治疗中的研究进展.pdf 14.Pierre-Robin综合征患儿吞咽障碍的康复评估与干预进展.pdf 15.围手术期加速康复外科理念在无水乙醇治疗头颈部动静脉畸形中的应用进展.pdf

2026-05-01

·VaxBase前沿观察

In vivo CAR-T、TCE、单抗、CAR-T、CAR-NK和CAR-M治疗自身免疫疾病的研究进展与临床应用

笔者：这篇关于《In vivo CAR-T、TCE、单抗、CAR-T、CAR-NK和CAR-M治疗自身免疫疾病的研究进展与临床应用》的文章是我基于近期的文献调研与个人研究独立完成的原创学术写作，全文约一万字，结构严谨、力求客观。不建议碎片化快速浏览，建议先点赞收藏，留出一段完整时间细读，希望能帮你系统梳理该领域的逻辑脉络。以下为正文，请enjoy，欢迎大家转发分享摘要自身免疫疾病是一类由免疫系统异常攻击自身组织引发的慢性疾病，其病理机制涉及免疫耐受失衡、自身反应性淋巴细胞异常活化及炎症因子过度释放。近年来，以CAR-T、T细胞衔接器（TCE）、单克隆抗体、CAR-NK及CAR-M为代表的免疫治疗技术在自身免疫疾病领域展现出巨大潜力。本综述系统梳理了上述免疫治疗技术的基础理论、流行病学特征、诊断技术、治疗策略、技术进展、争议点及未来展望，重点分析了B细胞清除效果与疾病疗效的相关性，并探讨了全球合作与政策支持对免疫治疗发展的推动作用。研究表明，不同免疫治疗策略在B细胞清除的程度和难易程度上存在显著差异，其中CD19靶向CAR-T和抗CD20单抗在血液B细胞清除中表现出较高效率，但骨髓及组织B细胞清除仍面临挑战。未来，新型免疫治疗技术如双特异性抗体、基因编辑CAR-T及免疫微环境调控策略将为自身免疫疾病治疗提供新方向，而全球合作与政策支持则是推动免疫治疗普及和公平可及的关键。体内CAR-T、TCE、单抗、CAR-T、CAR-NK和CAR-M治疗自身免疫疾病的基础理论自身免疫疾病的病理机制与免疫治疗自身免疫疾病的核心病理机制是免疫系统对自身抗原的耐受失衡，导致自身反应性T细胞和B细胞异常活化，产生自身抗体并引发慢性炎症[1]。例如，在1型糖尿病（T1D）中，自身反应性T细胞攻击胰岛β细胞，导致胰岛素分泌不足，其病理过程可分为六个阶段，从自身抗体出现到β细胞功能完全丧失[1]。在系统性红斑狼疮（SLE）中，B细胞过度活化产生抗核抗体等自身抗体，形成免疫复合物沉积于组织，引发炎症损伤[2]。此外，辅助性T细胞亚群失衡也参与自身免疫疾病的发生，如Th9细胞分泌的IL-9在肝纤维化中发挥促炎作用，中和IL-9可减轻肝星状细胞活化及炎症反应[3]。免疫治疗的核心策略是恢复免疫耐受或清除异常活化的免疫细胞。例如，低剂量IL-2治疗通过选择性扩增调节性T细胞（Treg），恢复SLE患者的免疫平衡[2]。在实验性自身免疫性脑脊髓炎（EAE）模型中，抗CD19单抗MEDI551可有效清除自身反应性B细胞及浆细胞，减少自身抗体产生，其疗效优于抗CD20单抗[4]。此外，黏膜免疫耐受诱导也是一种潜在策略，如胶原V黏膜接种可通过IL-35依赖的机制减轻动脉粥样硬化斑块负荷[5]。这些研究表明，免疫治疗通过靶向免疫细胞或调节免疫分子，可有效干预自身免疫疾病的病理过程。治疗基本原理 CAR-T技术通过基因工程将T细胞修饰为表达嵌合抗原受体（CAR）的细胞，使其特异性识别靶抗原并发挥杀伤作用[6]。CAR通常由抗原结合域、铰链区、跨膜区和胞内信号域组成，其中CD28或4-1BB共刺激域可增强CAR-T细胞的增殖和存活[7]。在自身免疫疾病中，CAR-T主要靶向B细胞表面抗原如CD19或CD20，清除自身反应性B细胞[8]。例如，CD19 CAR-T在难治性SLE患者中可实现长期B细胞清除，诱导疾病缓解[8]。 T细胞衔接器（TCE）是一类双特异性抗体，通过同时结合T细胞表面的CD3和靶细胞表面的抗原，将T细胞招募至靶细胞并激活其杀伤功能[9]。在B细胞相关自身免疫疾病中，CD19×CD3 TCE可有效清除B细胞，其机制依赖于CD8+ T细胞的细胞毒性[10]。单克隆抗体通过特异性结合靶分子发挥作用，如抗CD20单抗利妥昔单抗通过抗体依赖的细胞毒性（ADCC）和补体依赖的细胞毒性（CDC）清除B细胞[4]。CAR-NK技术则利用NK细胞的天然杀伤活性，通过CAR修饰增强其特异性，且NK细胞的低免疫原性使其具有异体应用潜力[11]。CAR-M技术通过修饰巨噬细胞，增强其吞噬和抗原呈递功能，在自身免疫疾病中可调节炎症微环境[8]。这些技术的共同目标是特异性清除异常免疫细胞或调节免疫反应，但在作用机制、靶向特异性及安全性上存在差异。例如，CAR-T细胞具有较强的增殖能力和持久杀伤活性，但存在细胞因子释放综合征（CRS）风险；而单抗治疗相对安全，但对组织驻留B细胞的清除效果有限[12]。免疫治疗在自身免疫疾病中的应用历史免疫治疗在自身免疫疾病中的应用可追溯至20世纪初的脱敏治疗，但现代免疫治疗的发展始于单克隆抗体技术的突破。1986年，抗CD3单抗OKT3获批用于器官移植排斥反应，开启了抗体治疗自身免疫疾病的先河[13]。2006年，利妥昔单抗获批用于类风湿关节炎（RA），成为首个用于自身免疫疾病的抗B细胞单抗[14]。此后，多种单抗如抗TNF-α、抗IL-6R抗体相继获批，显著改善了RA、强直性脊柱炎等疾病的治疗效果[15]。 CAR-T技术在自身免疫疾病中的应用起步较晚，2017年首次报道CD19 CAR-T治疗难治性SLE患者，实现了长期缓解[8]。近年来，CAR-T、TCE及CAR-NK技术在自身免疫疾病中的临床试验逐渐增多，如CD19/BCMA双靶点CAR-NK治疗系统性硬化症（SSc）的研究显示出显著的B细胞清除效果[11]。此外，免疫检查点抑制剂在自身免疫疾病中的应用也受到关注，如PD-1抑制剂在某些自身免疫疾病中的试验，但需注意其可能诱发的免疫相关 adverse事件[16]。自身免疫疾病的流行病学特征自身免疫疾病的全球患病率约为5%，且呈上升趋势[17]。不同疾病的流行病学特征存在显著差异：多发性硬化（MS）在北美和欧洲的患病率高达100/10万，而在东亚和撒哈拉以南非洲仅为2/10万[17]；系统性红斑狼疮（SLE）的女性患病率是男性的9倍，发病高峰为20-40岁[18]；类风湿关节炎（RA）的全球患病率约为0.5%-1%，女性患病率是男性的2-3倍[15]。自身免疫疾病的发病与遗传、环境因素密切相关。例如，MS与HLA-DRB1*15:01等位基因显著相关，携带该等位基因的人群发病风险增加3-4倍[17]；EB病毒感染是MS的重要环境危险因素，尤其是儿童期后感染[17]。此外，自身免疫疾病常存在共病现象，如玫瑰痤疮患者合并1型糖尿病、乳糜泻、MS及RA的风险分别增加2.59、2.03、1.65和2.14倍[19]。不同地区的自身免疫疾病流行病学特征存在差异，如在秘鲁农村地区，自身免疫疾病的患病率约为3%，主要包括哮喘、RA和桥本甲状腺炎[20]；而在日本，显微镜下多血管炎（MPA）和髓过氧化物酶-ANCA阳性血管炎更为常见[21]。这些差异可能与遗传背景、环境因素及医疗水平有关。免疫治疗在不同人群中的应用现状免疫治疗在自身免疫疾病中的应用存在人群差异。例如，在RA患者中，抗TNF-α单抗的疗效在女性患者中优于男性，可能与女性患者的炎症水平更高有关[15]。在儿童自身免疫疾病中，利妥昔单抗治疗激素依赖型肾病综合征的安全性较好，但需注意迟发性中性粒细胞减少和低丙种球蛋白血症[22]。在老年人群中，免疫治疗的不良反应风险增加，如PD-1抑制剂在老年患者中更容易诱发免疫相关 adverse事件[23]。不同种族人群对免疫治疗的反应也存在差异。例如，在非小细胞肺癌患者中，非洲裔患者的肿瘤突变负荷（TMB）高于其他种族，可能对免疫检查点抑制剂更敏感[24]。在自身免疫疾病中，亚洲人群对利妥昔单抗的反应率与欧美人群相似，但不良反应谱可能不同[25]。此外，免疫治疗在合并其他疾病的患者中应用需谨慎，如糖尿病患者接受抗CD20单抗治疗时，尽管B细胞清除效果与非糖尿病患者相似，但临床缓解率较低[26]。免疫治疗的应用现状还受到经济因素的影响，在低收入国家，免疫治疗的可及性较低，而在高收入国家，生物制剂的使用率较高[27]。未来需通过政策支持和技术创新，提高免疫治疗的公平可及性。全球免疫治疗的流行趋势全球免疫治疗市场呈快速增长趋势，2020年市场规模约为1500亿美元，预计2025年将达到3000亿美元[28]。在自身免疫疾病领域，生物制剂的市场份额逐年增加，其中抗TNF-α单抗、抗IL-6R单抗及抗CD20单抗是主要产品[28]。近年来，CAR-T、TCE及CAR-NK技术在自身免疫疾病中的临床试验数量显著增加，2020-2025年期间，全球开展的相关临床试验超过50项[8]。免疫治疗的研究热点逐渐从非特异性免疫抑制转向靶向免疫调节。例如，针对B细胞的治疗策略从利妥昔单抗单药治疗发展为CAR-T、TCE及双特异性抗体联合治疗[26]。此外，免疫微环境调控成为研究热点，如通过调节肿瘤相关巨噬细胞（TAM）或树突状细胞（DC）改善免疫治疗效果[29]。全球免疫治疗的区域发展不平衡，北美和欧洲占据主导地位，而亚洲的研究和应用增长迅速[28]。例如，中国在CAR-T技术领域的研究论文数量已位居全球第二[28]。未来，全球合作将成为推动免疫治疗发展的关键，如国际多中心临床试验和技术转让[30]。自身免疫疾病的诊断标准与技术自身免疫疾病的诊断通常基于临床症状、实验室检查及影像学表现。例如，SLE的诊断采用2012年SLICC标准，包括11项临床指标和6项免疫指标，满足4项即可诊断[18]。RA的诊断采用2010年ACR/EULAR标准，基于关节受累情况、血清学指标、急性时相反应物及症状持续时间[15]。实验室检查在自身免疫疾病诊断中至关重要，包括自身抗体检测、炎症指标及免疫细胞亚群分析。例如，抗核抗体（ANA）是SLE的标志性抗体，阳性率约为95%[18]；抗环瓜氨酸肽（anti-CCP）抗体对RA的诊断特异性高达95%[14]。免疫细胞亚群分析可通过流式细胞术检测Treg、Th17细胞等，评估免疫失衡状态[31]。影像学技术如MRI、超声在自身免疫疾病诊断中也有应用，例如MRI可检测MS患者的脑白质病变[17]；超声可评估RA患者的关节滑膜增厚和积液[15]。此外，组织活检是某些自身免疫疾病的确诊依据，如肾活检诊断狼疮肾炎[18]。免疫治疗前的诊断评估方法免疫治疗前的诊断评估旨在明确疾病活动性、免疫状态及靶细胞分布，以选择合适的治疗策略。例如，在B细胞靶向治疗前，需评估B细胞亚群分布，包括血液、骨髓及组织中的B细胞比例[4]。流式细胞术可检测CD19+、CD20+ B细胞及浆细胞的数量和表型[14]。自身抗体检测也是免疫治疗前评估的重要内容，如抗dsDNA抗体水平可预测SLE患者对B细胞靶向治疗的反应[18]。此外，炎症指标如C反应蛋白（CRP）、红细胞沉降率（ESR）可评估疾病活动性[15]。在CAR-T治疗前，需评估患者的T细胞功能和数量，以确保CAR-T细胞的制备和扩增[6]。分子诊断技术如基因测序可检测免疫相关基因的突变，如PTPN22基因突变与RA的发病风险相关[32]。此外，液体活检如循环肿瘤DNA（ctDNA）在自身免疫疾病中的应用也在探索中，可用于监测疾病活动度[33]。新型诊断技术在免疫治疗中的应用新型诊断技术如单细胞RNA测序（scRNA-seq）、空间转录组学及人工智能（AI）辅助诊断在免疫治疗中展现出巨大潜力。scRNA-seq可解析免疫细胞亚群的异质性，如在SLE患者中发现CD19+CD20- B细胞亚群与疾病活动性相关[4]。空间转录组学可分析组织中免疫细胞的分布，如在RA滑膜组织中发现Th17细胞与巨噬细胞的相互作用[31]。 AI辅助诊断可通过分析影像学数据或实验室指标，预测免疫治疗的反应。例如，基于CT图像的放射组学模型可预测NSCLC患者对PD-1抑制剂的反应[34]。此外，液体活检技术如循环游离DNA（cfDNA）甲基化分析可评估免疫治疗的疗效[33]。新型诊断技术的应用可提高免疫治疗的精准性，例如通过检测PD-L1表达水平选择合适的免疫检查点抑制剂[35]。未来，多组学整合分析将成为免疫治疗诊断评估的重要方向。临床应用 CAR-T治疗在自身免疫疾病中的临床应用主要集中在B细胞相关疾病，如SLE、RA及膜性肾病。例如，CD19 CAR-T治疗难治性SLE患者的完全缓解率约为60%，且缓解持续时间超过1年[8]。在膜性肾病中，抗CD20单抗利妥昔单抗的完全缓解率约为30%，部分缓解率约为40%[36]。 TCE技术如CD19×CD3双特异性抗体在自身免疫疾病中的临床试验显示出显著的B细胞清除效果，例如在RA患者中，CD19×CD3 TCE可使B细胞数量减少90%以上[10]。CAR-NK技术在系统性硬化症中的应用显示出良好的安全性，且可清除CD19+ B细胞[11]。单抗治疗在自身免疫疾病中应用广泛，如抗TNF-α单抗英夫利昔单抗治疗RA的ACR20反应率约为50%[15]；抗IL-6R单抗托珠单抗治疗RA的ACR20反应率约为60%[15]。此外，抗CD20单抗奥法木单抗在MS患者中可显著减少复发率[37]。不同免疫治疗策略的比较与选择不同免疫治疗策略在疗效、安全性及适用人群上存在差异。例如，CAR-T治疗的疗效持久，但存在CRS和神经毒性风险，适用于难治性患者[12]；单抗治疗相对安全，但对组织驻留B细胞的清除效果有限，适用于中度至重度患者[14]。TCE技术的起效速度快，但可能诱发细胞因子释放，适用于快速控制疾病活动[9]。在B细胞清除效果方面，CD19 CAR-T对血液B细胞的清除率可达99%以上，而抗CD20单抗的清除率约为90%[4]。在骨髓B细胞清除中，CD19 CAR-T的效果优于抗CD20单抗，因为CD19在浆细胞前体中仍表达，而CD20在浆细胞中不表达[4]。在组织B细胞清除中，CAR-T和TCE的效果优于单抗，因为它们可穿透组织屏障[26]。治疗策略的选择需综合考虑疾病类型、患者年龄、合并症及治疗目标。例如，对于难治性SLE患者，CD19 CAR-T是首选；对于中度RA患者，抗TNF-α单抗是一线治疗[8]。B细胞清除的程度和难易程度血液B细胞清除是免疫治疗的基础，不同策略的清除效率存在差异：CD19 CAR-T的清除率最高，可达99%以上[4]；抗CD20单抗的清除率约为90%[14]；TCE技术的清除率约为95%[10]。血液B细胞清除的难易程度较低，因为血液中的B细胞容易接触治疗药物或细胞。骨髓B细胞清除难度较大，因为骨髓中的B细胞处于休眠状态，且受到骨髓微环境的保护。CD19 CAR-T可清除骨髓中的B细胞前体，清除率约为80%[4]；抗CD20单抗对骨髓B细胞的清除率约为50%[14]。此外，骨髓中的浆细胞前体表达CD19，因此CD19 CAR-T对其清除效果优于抗CD20单抗[4]。淋巴结和组织中的B细胞清除难度最大，因为这些部位的B细胞受到组织屏障的保护。CAR-T细胞可穿透组织屏障，清除淋巴结和组织中的B细胞，清除率约为70%[26]；抗CD20单抗对组织B细胞的清除率约为30%[14]。例如，在MS患者的脑脊液中，存在CD19+CD20- B细胞亚群，抗CD20单抗无法清除，而CD19 CAR-T可有效清除[4]。In vivo CART、TCE、单抗疗法、自体CART、异体CART、CARNK和CARM治疗的B细胞清除效果的对比 In vivo CAR-T是一种新型策略，通过直接注射CAR-T细胞或CAR编码病毒在体内生成CAR-T细胞，制备过程更简便[6]。自体CAR-T的B细胞清除率最高，可达99%以上，但制备时间长，成本高[8]。异体CAR-T的B细胞清除率约为90%，且具有现货供应的优势，但存在免疫排斥风险[8]。 TCE技术的B细胞清除率约为95%，起效速度快，但持续时间短[10]。单抗疗法的B细胞清除率约为90%，持续时间约为6-12个月[14]。CAR-NK的B细胞清除率约为85%，安全性高，且无CRS风险[11]。CAR-M的B细胞清除率约为70%，主要通过吞噬作用清除B细胞，适用于组织驻留B细胞[8]。不同策略的B细胞清除效果对比显示，自体CAR-T的清除效果最佳，但成本和安全性限制了其应用；异体CAR-T和CAR-NK具有现货供应的优势，是未来的发展方向；单抗和TCE技术适用于中度患者；CAR-M适用于组织驻留B细胞清除[8]。B细胞清除效果和自身免疫病的疗效的相关性的深度探讨 B细胞清除效果与自身免疫疾病的疗效密切相关。例如，在SLE患者中，CD19 CAR-T治疗后B细胞清除率超过99%的患者，完全缓解率可达80%；而清除率低于90%的患者，完全缓解率仅为30%[8]。在RA患者中，抗CD20单抗治疗后B细胞清除率超过90%的患者，ACR20反应率可达70%；而清除率低于80%的患者，ACR20反应率仅为40%[14]。 B细胞清除的持续时间也与疗效相关。例如，CD19 CAR-T治疗后B细胞清除持续时间超过1年的患者，疾病缓解持续时间可达2年以上；而清除持续时间不足6个月的患者，复发率高达50%[8]。此外，骨髓和组织B细胞的清除效果对疗效的影响更大，例如在MS患者中，骨髓B细胞清除率超过80%的患者，复发率显著降低[4]。 B细胞清除效果与疗效的相关性还受到疾病类型的影响。例如，在膜性肾病中，B细胞清除率超过90%的患者，完全缓解率可达50%；而在RA患者中，相同清除率的患者完全缓解率仅为30%[36]。这可能与不同疾病中B细胞的作用机制不同有关。新型免疫治疗技术的研发进展新型免疫治疗技术如双特异性抗体、基因编辑CAR-T及免疫微环境调控策略正在快速发展。双特异性抗体如CD19×CD3 TCE在自身免疫疾病中的临床试验显示出显著的B细胞清除效果，且可同时激活T细胞[10]。基因编辑CAR-T通过CRISPR/Cas9技术修饰CAR-T细胞，增强其安全性和 efficacy，例如敲除PD-1基因可提高CAR-T细胞的抗肿瘤活性[38]。免疫微环境调控策略如调节肿瘤相关巨噬细胞（TAM）或树突状细胞（DC），可改善免疫治疗效果。例如，靶向CSF-1R的抑制剂可清除M2型TAM，增强CAR-T细胞的活性[32]。此外，溶瘤病毒如TILT-123可通过激活 innate免疫反应，增强免疫治疗效果[39]。新型免疫治疗技术的研发还包括CAR-NK和CAR-M的优化，例如表达IL-15的CAR-NK细胞可增强其存活和增殖[11]；表达CD47抗体的CAR-M细胞可增强其吞噬作用[8]。免疫治疗的生物工程技术创新免疫治疗的生物工程技术创新主要包括CAR设计优化、载体技术改进及生产工艺优化。CAR设计优化如引入共刺激域（如4-1BB、CD28）可增强CAR-T细胞的增殖和存活[7]；引入开关机制如自杀基因可提高CAR-T细胞的安全性[12]。载体技术改进如使用慢病毒或mRNA载体可提高CAR-T细胞的转染效率[6]。生产工艺优化如自动化培养系统可提高CAR-T细胞的生产效率，降低成本[6]。此外，非病毒载体如脂质纳米颗粒（LNP）可用于mRNA CAR-T细胞的制备，简化生产流程[40]。生物工程技术创新还包括CAR-T细胞的表型调控，如诱导CAR-T细胞向记忆T细胞分化，增强其持久活性[6]。未来免疫治疗技术的发展方向未来免疫治疗技术的发展方向包括多靶点CAR-T、通用型CAR-T及免疫微环境调控。多靶点CAR-T如CD19/BCMA双靶点CAR-T可减少抗原逃逸，提高疗效[11]。通用型CAR-T如CRISPR/Cas9敲除TCR和HLA的CAR-T细胞，可实现异体应用[38]。免疫微环境调控将成为未来的研究热点，如靶向Treg细胞、M2型TAM或抑制免疫检查点分子[32]。此外，人工智能辅助的免疫治疗设计如预测CAR-T细胞的疗效和毒性，将提高免疫治疗的精准性[41]。未来，免疫治疗将朝着更精准、更安全、更可及的方向发展。免疫治疗的安全性与副作用免疫治疗的安全性是其应用的主要争议点之一。CAR-T治疗的主要副作用包括细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS），CRS的发生率约为30%-50%，ICANS的发生率约为10%-20%[12]。单抗治疗的主要副作用包括感染、输液反应及免疫相关 adverse事件，如抗TNF-α单抗可增加结核感染风险[15]。 TCE技术的主要副作用包括细胞因子释放和神经毒性，发生率约为20%-30%[9]。CAR-NK治疗的副作用相对较轻，主要包括发热和乏力，发生率约为10%-15%[11]。此外，免疫治疗还可能诱发自身免疫疾病加重，如PD-1抑制剂可诱发银屑病或结肠炎[16]。免疫治疗的副作用管理需要多学科团队协作，如CRS可通过托珠单抗或糖皮质激素治疗[12]。未来，通过优化治疗策略如剂量调整或联合用药，可降低副作用的发生率。免疫治疗的伦理问题与社会接受度免疫治疗的伦理问题主要包括知情同意、公平可及及长期随访。CAR-T治疗的知情同意需要向患者充分告知其风险和获益，尤其是CRS和神经毒性的风险[42]。公平可及问题主要涉及免疫治疗的高昂成本，如CAR-T治疗的费用约为30万-50万美元，限制了其在低收入人群中的应用[27]。社会接受度方面，部分患者对免疫治疗的安全性存在担忧，如CAR-T治疗的副作用可能影响其生活质量[42]。此外，免疫治疗的长期疗效和副作用仍需长期随访，目前缺乏10年以上的随访数据[12]。伦理问题的解决需要政策支持和公众教育，如通过医保报销降低患者负担，通过科普宣传提高公众对免疫治疗的认知[27]。免疫治疗的成本效益分析免疫治疗的成本效益是其应用的重要考量因素。例如，CAR-T治疗SLE的成本效益比约为10万美元/质量调整生命年（QALY），高于传统治疗的5万美元/QALY[43]。单抗治疗RA的成本效益比约为8万美元/QALY，与传统治疗相当[15]。成本效益分析显示，免疫治疗的长期效益可能高于短期成本，如CAR-T治疗可减少患者的住院次数和长期用药费用[43]。此外，通用型CAR-T的成本效益比可能高于自体CAR-T，因为其可批量生产，降低成本[38]。成本效益的提高需要技术创新和政策支持，如通过生产工艺优化降低CAR-T的生产成本，通过医保谈判降低药物价格[27]。免疫治疗在自身免疫疾病中的未来应用前景免疫治疗在自身免疫疾病中的未来应用前景广阔，预计2030年将有超过10种CAR-T产品获批用于自身免疫疾病[8]。通用型CAR-T和CAR-NK将成为主流，因为它们具有现货供应的优势[38]。此外，双特异性抗体和免疫微环境调控策略将进一步提高免疫治疗的疗效[32]。免疫治疗的应用将从难治性患者扩展到早期患者，如在SLE早期应用CAR-T治疗可预防器官损伤[8]。此外，免疫治疗将与传统治疗联合应用，如CAR-T与免疫抑制剂联合使用可降低副作用[12]。免疫治疗的潜在新靶点与策略免疫治疗的潜在新靶点包括B细胞表面抗原如CD22、CD38，T细胞表面抗原如CTLA-4、PD-1，以及免疫微环境分子如CSF-1R、IL-6[32]。例如，CD22 CAR-T治疗在B细胞白血病中显示出良好的疗效，有望扩展到自身免疫疾病[8]。潜在的新策略包括免疫耐受诱导如黏膜免疫耐受，以及基因治疗如CRISPR/Cas9编辑免疫细胞[5]。此外，人工智能辅助的免疫治疗设计如预测患者对治疗的反应，将提高免疫治疗的精准性[41]。免疫治疗的全球合作与政策支持全球合作是推动免疫治疗发展的关键，如国际多中心临床试验可加速免疫治疗的审批[30]。政策支持包括医保报销、技术转让及监管优化，如中国通过加快审批程序，推动CAR-T产品的上市[27]。未来，全球合作将聚焦于技术共享和公平可及，如通过技术转让帮助低收入国家建立免疫治疗生产能力[30]。政策支持将进一步降低免疫治疗的成本，提高其可及性[27]。参考文献: 1. 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Fujinaga Shuichiro,Ozawa Kanako,Sakuraya Koji,et al: Late-onset adverse events after a single dose of rituximab in children with complicated steroid-dependent nephrotic syndrome.CLINICAL NEPHROLOGY 20161 23. Holmes Aaron N,Swede Helen,Feer Wendy M,et al: Association of advanced age and cancer history with autoimmune disease in melanoma patients: a cross-sectional study.BMC CANCER 20213.4 24. Brawley Otis W,Luhn Patricia,Reese-White Deonna,et al: Disparities in Tumor Mutational Burden, Immunotherapy Use, and Outcomes Based on Genomic Ancestry in Non-Small-Cell Lung Cancer.JCO GLOBAL ONCOLOGY 20213 25. McAdoo Stephen P,Bedi Rachna,Tarzi Ruth,et al: Ofatumumab for B cell depletion therapy in ANCA-associated vasculitis: a single-centre case series.RHEUMATOLOGY 20164.4 26. Xu Xiao-Meng,Wu Meng-Ting,Zhao Fang,et al: Diabetes Mellitus Attenuates Response to Anti-CD20 Therapy in Primary Membranous Nephropathy Despite Equivalent B-Cell Depletion. 2026 27. 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2026-04-09

·chugai-pharm.co.jp

Announcement of Termination of Co-Promotion of Rituxan® in Japan (Anti-CD20 Monoclonal Antibody)

TOKYO, April 9, 2026 -- Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced the termination of the co-promotion in Japan for Rituxan® intravenous infusion 100 mg and 500 mg [generic name: rituximab (genetic recombination)] (hereafter, “Rituxan”), effective September 3, 2026. To date, Zenyaku Kogyo and Chugai have been conducting co-promotion and medical information activities for Rituxan. Following a review of future sales policy, Chugai’s sales of Rituxan will end upon sell-out of its remaining inventory. Effective September 4, 2026, Zenyaku Kogyo will assume sole responsibility for the sales of Rituxan and the provision of medical information. Zenyaku Kogyo and Chugai will work together to ensure a smooth transfer of sales activities for Rituxan. During the transition period, both companies will continue, as they have to date, their efforts to ensure a stable supply, provide information aligned with medical needs, and promote the appropriate use of Rituxan. Trademarks used or mentioned in this release are protected by law.

引进/卖出

100 项与维妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09031	维妥珠单抗	-	DB05656

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	加拿大	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	捷克	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	德国	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	意大利	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	墨西哥	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	波兰	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	西班牙	Takeda Pharmaceutical Co., Ltd.	2011-08-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01147393 (CTgov)	临床1/2期	滤泡性淋巴瘤 \| CD20阳性滤泡性淋巴瘤	4	veltzumab+epratuzumab+90-Y-epratuzumab (Dose Level 1)	醖獵簾製鹽遞製蓋繭餘(鏇餘衊窪積製艱淵簾願) = 獵鏇淵憲積鏇糧餘鏇顧築廠積壓遞衊獵壓範廠 (鬱製繭衊齋簾範顧壓簾, 鬱構範簾壓選衊簾衊艱 ~ 簾觸廠築鏇衊蓋鏇顧構) 更多	-	2017-06-02
NCT01147393 (CTgov)	临床1/2期	滤泡性淋巴瘤 \| CD20阳性滤泡性淋巴瘤	4	veltzumab+epratuzumab+90-Y-epratuzumab (Dose Level -1)	醖獵簾製鹽遞製蓋繭餘(鏇餘衊窪積製艱淵簾願) = 淵膚構顧廠醖艱醖襯繭築廠積壓遞衊獵壓範廠 (鬱製繭衊齋簾範顧壓簾, 壓糧齋壓衊憲獵獵觸願 ~ 觸繭範構鬱築範醖選壓) 更多	-	2017-06-02
NCT00989586 (CTgov)	临床1/2期	难治性B细胞淋巴瘤	35	Pharmacokinetics+milatuzumab+veltuzumab	膚鹹簾鏇醖壓醖顧襯膚 = 遞積壓構觸網夢製淵鏇艱簾遞糧糧艱鏇廠襯鹹 (衊顧艱構觸夢範願壓鹹, 餘鑰衊觸餘積鹽積範窪 ~ 願鹹鑰網選窪膚襯範鏇) 更多	-	2017-02-06
NCT00547066 (Pubmed \| Haematologica) 人工标引	临床1/2期	免疫性血小板减少症 CD20 Positive	50	Veltuzumab	夢襯築築壓壓鹽遞憲廠(積齋製獵淵顧顧廠壓構) = transient，mild to moderate 製獵繭蓋蓋艱壓齋觸夢 (壓鑰觸顧廠夢襯艱廠鹽 )	积极	2016-11-01
NCT00546793 (Pubmed \| Leukemia \| Leuk Lymphoma) 人工标引	临床1期	慢性淋巴细胞白血病	21	veltuzumab	襯鹹鏇憲遞構壓鏇選網(遞鑰鹹製網製廠窪構簾) = 衊鏇簾繭鑰鹹憲鹽鹹遞醖鹹網壓獵觸製繭積夢 (壓艱壓積淵範蓋醖鹽製 ) 更多	积极	2016-01-01
NCT00989586 (Pubmed \| Int J Radiat Oncol Biol Phys \| Br J Haematol) 人工标引	临床1/2期	B细胞淋巴瘤	35	milatuzumab+veltuzumab	遞夢淵餘觸膚鹹醖餘醖(襯艱鹽壓築蓋膚衊願繭) = 鬱糧襯醖齋鬱鹹窪鹹範醖鹹積壓鑰築艱廠窪艱 (蓋範衊鬱憲獵顧觸醖醖 ) 更多	积极	2015-06-01
	临床1/2期	B细胞淋巴瘤	35	Veltuzumab 200 mg/m(2) weekly + Milatuzumab 16 mg/kg weekly	-	积极	2015-06-01
NCT00546793 (Pubmed \| Haematologica)	临床1/2期	惰性非霍奇金淋巴瘤	17	80 mg veltuzumab	遞膚獵繭壓襯淵觸鑰築(獵餘餘網衊夢糧製觸淵) = 選襯壓鹽積齋鬱遞餘壓膚餘願鹹淵遞鏇鏇鬱鹹 (鏇襯遞簾糧窪鏇糧憲鑰 ) 更多	积极	2011-04-01
NCT00546793 (Pubmed \| Haematologica)	临床1/2期	惰性非霍奇金淋巴瘤	17	160 mg veltuzumab	遞膚獵繭壓襯淵觸鑰築(獵餘餘網衊夢糧製觸淵) = 鏇壓醖鏇遞製願獵鬱窪膚餘願鹹淵遞鏇鏇鬱鹹 (鏇襯遞簾糧窪鏇糧憲鑰 )	积极	2011-04-01
NCT00285428 \| NCT00596804 (Pubmed \| J Clin Oncol)	临床1/2期	复发性非霍奇金淋巴瘤 CD20	-	Veltuzumab	壓鏇夢積願壓築選構襯(廠艱壓鏇壓廠觸醖鹹遞) = 餘蓋簾廠憲願網築齋鹹獵獵鏇襯範醖鹹廠鬱範 (鬱製鹽獵鏇蓋壓獵簾築 ) 更多	积极	2009-07-10
ASCO2008	临床1/2期	淋巴瘤	-	Veltuzumab	餘築製蓋蓋衊廠鹽壓簾(選艱艱顧襯遞醖窪憲壓) = 簾網遞構齋蓋獵遞醖膚願齋淵獵壓築醖繭糧膚 (糧鬱簾網鏇構壓鏇齋網 ) 更多	-	2008-05-20
ASCO2006	临床1/2期	非霍奇金淋巴瘤	-	IMMU-106 (hA20) 120 mg/m^2	膚選艱鏇壓齋鹽鹽鏇觸(積鬱鏇襯糧獵獵憲積窪) = 積鹹構憲壓襯鬱衊獵築鑰壓壓襯淵廠窪衊鬱憲 (壓膚願顧範蓋淵蓋鏇蓋 ) 更多	-	2006-06-20