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Lisocabtagene maraleucel - 版本历史
2026-04-18T10:38:19Z
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2026-01-19T03:33:15Z
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<p><b>新页面</b></p><div><div style="padding: 0 4%; line-height: 1.8; color: #1e293b; font-family: 'Helvetica Neue', Helvetica, 'PingFang SC', Arial, sans-serif; background-color: #ffffff; max-width: 1200px; margin: auto;"><br />
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<strong>[[Lisocabtagene maraleucel]]</strong>（简称 <strong>[[liso-cel]]</strong>，商品名：<strong>[[Breyanzi]]</strong>）是一款针对 <strong>[[CD19]]</strong> 抗原的自体 <strong>[[嵌合抗原受体T细胞疗法]]</strong>（[[CAR-T]]）。该疗法的独特之处在于其成分包含固定比例（1:1）的 <strong>[[CD4+]]</strong> 和 <strong>[[CD8+]]</strong> CAR-T 细胞，旨在提高抗肿瘤活性的可预测性和降低毒性。截至 2026 年，liso-cel 已被批准用于多种 [[B细胞]] 恶性肿瘤的二线及后线治疗，包括 [[弥漫性大B细胞淋巴瘤]]（[[DLBCL]]）、[[慢性淋巴细胞白血病]]（[[CLL]]）以及 [[滤泡性淋巴瘤]]（[[FL]]），成为 [[细胞治疗]] 领域的支柱药物之一。<br />
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<div style="font-size: 1.1em; font-weight: bold; letter-spacing: 1px;">Lisocabtagene maraleucel</div><br />
<div style="font-size: 0.75em; opacity: 0.85; margin-top: 4px;">Cell Therapy: [[CAR-T]] · 点击展开详情</div><br />
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<div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">自体 [[CD19]] 靶向 T 细胞</div><br />
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<td style="padding: 10px 12px; border-bottom: 1px solid #e2e8f0;">[[CD19]]</td><br />
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<th style="text-align: left; padding: 10px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[Entrez]] (Target)</th><br />
<td style="padding: 10px 12px; border-bottom: 1px solid #e2e8f0;">930</td><br />
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<th style="text-align: left; padding: 10px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[UniProt]] (Target)</th><br />
<td style="padding: 10px 12px; border-bottom: 1px solid #e2e8f0;">P15391</td><br />
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<th style="text-align: left; padding: 10px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">共刺激域</th><br />
<td style="padding: 10px 12px; border-bottom: 1px solid #e2e8f0;">[[4-1BB]] ([[CD137]])</td><br />
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<th style="text-align: left; padding: 10px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">激活域</th><br />
<td style="padding: 10px 12px; border-bottom: 1px solid #e2e8f0;">[[CD3&zeta;]]</td><br />
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<th style="text-align: left; padding: 10px 12px; background-color: #f1f5f9; color: #475569;">研发商</th><br />
<td style="padding: 10px 12px;">[[BMS]] (原 [[Juno]])</td><br />
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liso-cel 通过基因工程手段使患者自身的 T 细胞表达嵌合抗原受体。其分子构造与生物学过程如下：<br />
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<li style="margin-bottom: 12px;"><strong>[[抗原识别]]：</strong>利用单链可变片段（[[scFv]]）特异性结合 B 细胞表面的 [[CD19]] 蛋白。</li><br />
<li style="margin-bottom: 12px;"><strong>[[信号转导]]：</strong>结合抗原后，信号通过 <strong>[[4-1BB]]</strong> 共刺激域和 <strong>[[CD3&zeta;]]</strong> 链传递，诱导 T 细胞增殖及细胞毒性分子的释放。</li><br />
<li style="margin-bottom: 12px;"><strong>[[成分标准化]]：</strong>与其他 CAR-T 不同，liso-cel 在回输前将 [[CD4+]] 和 [[CD8+]] 细胞分别扩增并按 <strong>1:1</strong> 比例混合。这种标准化有助于降低体内扩增的不确定性，从而减少 <strong>[[细胞因子风暴]]</strong>（[[CRS]]）的发生频率。</li><br />
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<h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #1e40af; font-weight: bold;">临床研究：TRANSCEND 系列数据矩阵</h2><br />
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<th style="padding: 12px; border: 1px solid #cbd5e1;">临床试验</th><br />
<th style="padding: 12px; border: 1px solid #cbd5e1;">适应症</th><br />
<th style="padding: 12px; border: 1px solid #cbd5e1;">主要结局 ([[ORR]]/[[CR]])</th><br />
<th style="padding: 12px; border: 1px solid #cbd5e1;">2026 临床地位</th><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: bold;">[[TRANSCEND NHL 001]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">复发/难治性 [[LBCLC]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">ORR: 73%, CR: 53%</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">三线及以上标准方案</td><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: bold;">[[TRANSFORM]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">二线早期复发 [[LBCLC]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">对比 [[ASCT]] 显著延长 [[EFS]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">二线首选推荐</td><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: bold;">[[TRANSCEND CLL 004]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">复发/难治性 [[CLL]]/[[SLL]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">CR/hCR: 20% (经 BTKi 进展)</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">针对高度难治人群的突破</td><br />
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<h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #1e40af; font-weight: bold;">治疗策略与安全性管理</h2><br />
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<li style="margin-bottom: 12px;"><strong>[[单采与制备]]：</strong>通过 <strong>[[白细胞单采]]</strong> 获取患者 T 细胞，运送至中心实验室进行基因修饰，周期约 3-4 周。</li><br />
<li style="margin-bottom: 12px;"><strong>[[清淋化疗]]：</strong>回输前需接受 <strong>[[氟达拉滨]]</strong> 和 <strong>[[环磷酰胺]]</strong> 预处理，以清除内源性淋巴细胞，为 CAR-T 扩增创造环境。</li><br />
<li style="margin-bottom: 12px;"><strong>[[毒性监测]]：</strong>重点防范 <strong>[[细胞因子释放综合征]]</strong>（CRS）及 <strong>[[ICANS]]</strong>（神经毒性）。因其固定比例特性，liso-cel 的严重 CRS（Grade &ge;3）发生率通常低于 5%。</li><br />
<li style="margin-bottom: 12px;"><strong>[[中性粒细胞减少]]：</strong>需警惕长期血细胞减少，必要时使用生血因子支持。</li><br />
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<h3 style="color: #0f172a; font-size: 1.15em; margin-bottom: 20px; border-bottom: 2px solid #1e40af; display: inline-block; padding-bottom: 5px;">关键相关概念</h3><br />
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<div style="color: #334155;"><strong style="color: #1e40af;">[[Axi-cel]]</strong>：另一款 CD19 CAR-T，使用 CD28 共刺激域，动力学较快但毒性略高。</div><br />
<div style="color: #334155;"><strong style="color: #1e40af;">[[4-1BB]]</strong>：liso-cel 使用的共刺激信号，通常与较长的体内持久性和较低的耗竭率相关。</div><br />
<div style="color: #334155;"><strong style="color: #1e40af;">[[自体免疫排斥]]</strong>：CAR-T 作为自体细胞产品，不存在传统的移植物抗宿主病风险。</div><br />
<div style="color: #334155;"><strong style="color: #1e40af;">[[CD19阴性逸脱]]</strong>：复发的主要机制之一，肿瘤细胞下调靶抗原以逃避识别。</div><br />
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<span style="color: #0f172a; font-weight: bold; font-size: 1.05em; display: inline-block; margin-bottom: 15px;">学术参考文献 [Academic Review]</span><br />
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[1] <strong>Abramson JS, et al. (2020).</strong> Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. <em><strong>[[The Lancet]]</strong></em>. 396(10254):839-852.<br />
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[2] <strong>Kamdar M, et al. (2022).</strong> Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. <em><strong>[[The Lancet]]</strong></em>. 399(10341):2097-2108.<br />
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[3] <strong>Siddiqi T, et al. (2023).</strong> Lisocabtagene maraleucel in relapsed or refractory chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. <em><strong>[[The Lancet]]</strong></em>. 402(10402):641-654.<br />
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[[Lisocabtagene maraleucel]] (liso-cel) · 知识图谱导航<br />
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<td style="width: 120px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 12px 15px;">药物类别</td><br />
<td style="padding: 12px 15px; color: #334155;">[[细胞免疫疗法]] • [[CAR-T]] • [[自体T细胞]] • [[177Lu-PSMA-617]]类比精准性</td><br />
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<td style="background-color: #f8fafc; color: #334155; font-weight: 600; padding: 12px 15px;">获批适应症</td><br />
<td style="padding: 12px 15px; color: #334155;">[[DLBCL]] • [[滤泡性淋巴瘤]] • [[CLL]] • [[套细胞淋巴瘤]] (MCL)</td><br />
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<td style="background-color: #f8fafc; color: #334155; font-weight: 600; padding: 12px 15px;">竞争产品</td><br />
<td style="padding: 12px 15px; color: #334155;">[[Axicabtagene ciloleucel]] • [[Tisagenlecleucel]] • [[Epcoritamab]] (双抗)</td><br />
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