查看“Abecma”的源代码

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            <strong>[[Abecma]]</strong>（通用名：<strong>[[Idecabtagenevicleucel]]</strong>，简称<strong>[[Ide-cel]]</strong>）是全球首个获批上市的针对<strong>[[B细胞成熟抗原]]</strong>（<strong>[[BCMA]]</strong>）的自体<strong>[[CAR-T]]</strong>（嵌合抗原受体T细胞）免疫疗法。该疗法通过基因工程手段，将患者自身的<strong>[[T细胞]]</strong>转化为能够特异性识别并攻击高表达<strong>[[BCMA]]</strong>的恶性浆细胞的“活药”。<strong>[[Abecma]]</strong>主要用于治疗既往接受过三类及以上药物（包括免疫调节剂、蛋白酶体抑制剂和抗<strong>[[CD38]]</strong>单抗）治疗失败的复发或难治性<strong>[[多发性骨髓瘤]]</strong>（RRMM）成年患者。它的问世打破了末线骨髓瘤患者无药可医的困境，是血液肿瘤<strong>[[精准医疗]]</strong>领域的里程碑式突破。
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            <div style="font-size: 1.2em; font-weight: bold; letter-spacing: 1.2px;">Abecma(Ide-cel)</div>
            <div style="font-size: 0.7em; opacity: 0.85; margin-top: 4px; white-space: nowrap;">Idecabtagene vicleucel·BCMA靶向·点击展开</div>
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                <div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">核心靶标：<strong>[[BCMA]]</strong>(TNFRSF17)</div>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0; width: 40%;"><strong>[[Entrez]]</strong>ID</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">608(<strong>[[BCMA]]</strong>)</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">药物类型</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">自体免疫细胞疗法</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">共刺激域</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;"><strong>[[4-1BB]]</strong>(CD137)</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">研发厂家</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;"><strong>[[BMS]]</strong>/<strong>[[2seventybio]]</strong></td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">载体类型</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;"><strong>[[慢病毒]]</strong>载体</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569;">审批状态</th>
                    <td style="padding: 12px; color: #16a34a;"><strong>[[FDA]]</strong>/<strong>[[EMA]]</strong>已上市</td>
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        <strong>[[Abecma]]</strong>通过赋予患者<strong>[[T细胞]]</strong>一个“全新的导航系统”来工作。其CAR结构的精密设计决定了其强效的抗肿瘤能力：
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        <li style="margin-bottom: 12px;">受体特异性结合：CAR结构的胞外区包含一个抗<strong>[[BCMA]]</strong>的单链抗体片段（scFv），能精准识别并锚定骨髓瘤细胞表面的<strong>[[BCMA]]</strong>。<strong>[[BCMA]]</strong>主要表达于成熟B细胞和浆细胞，在非造血组织中几乎不表达。</li>
        <li style="margin-bottom: 12px;">双重信号转导：当scFv结合靶点后，胞内区的<strong>[[CD3ζ]]</strong>结构域启动第一信号。随后，<strong>[[4-1BB]]</strong>（CD137）共刺激结构域通过<strong>[[TRAF]]</strong>通路传递第二信号，极大地增强了<strong>[[CAR-T]]</strong>细胞在体内的增殖能力、存续时间及细胞毒杀伤效能。</li>
        <li style="margin-bottom: 12px;">非MHC限制性杀伤：这种结合方式不依赖于<strong>[[MHC]]</strong>分子的提呈，有效规避了肿瘤细胞通过下调MHC表达而实现的免疫逃逸。</li>
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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 #0f172a; font-weight: bold;">临床评价矩阵：KarMMa系列研究数据</h2>

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                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #0f172a; width: 25%;">评价终点</th>
                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #475569;">KarMMa(末线)</th>
                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #1e40af;">KarMMa-3(早期线)</th>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">客观缓解率(ORR)</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;"><strong>73.0%</strong></td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">71.0%</td>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">完全缓解率(CR+)</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">33.0%</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">44.0%</td>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">中位无进展生存期</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">8.8个月</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">13.3个月</td>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">安全性特征</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;" colspan="2;">主要风险为<strong>[[细胞因子释放综合征]]</strong>(CRS,84%-88%)及<strong>[[神经毒性]]</strong>(ICANS)。多数为1-2级。</td>
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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 #0f172a; font-weight: bold;">治疗策略：从单采到回输的全生命周期管理</h2>
    <p style="margin: 15px 0; text-align: justify;">
        作为一种高度个体化的活细胞治疗，<strong>[[Abecma]]</strong>的临床管理涉及多个严谨环节：
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        <li style="margin-bottom: 12px;">细胞制备流程：患者首先进行白细胞单采，随后<strong>[[T细胞]]</strong>被送至中央工厂进行基因修饰和体外扩增。这一过程通常需要3-4周，在此期间可能需要“桥接疗法”维持病情。</li>
        <li style="margin-bottom: 12px;">清淋预处理：回输前3天，患者接受由<strong>[[环磷酰胺]]</strong>和<strong>[[氟达拉滨]]</strong>组成的清淋化疗。这一步骤旨在清除患者体内的免疫抑制性细胞，为<strong>[[CAR-T]]</strong>细胞回输后的快速扩增开辟“物理与生化空间”。</li>
        <li style="margin-bottom: 12px;">严重毒性救治：回输后需至少在治疗中心观察7-14天。对于发生严重<strong>[[CRS]]</strong>的患者，应迅速使用<strong>[[托珠单抗]]</strong>进行救治；对于发生<strong>[[ICANS]]</strong>的患者，则首选<strong>[[地塞米松]]</strong>等皮质类固醇激素。</li>
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            <li style="margin-bottom: 8px;"><strong>[[BCMA]]</strong>：浆细胞系的核心靶标，是目前骨髓瘤细胞免疫治疗的头号阵地。</li>
            <li style="margin-bottom: 8px;"><strong>[[西达基奥仑赛]]</strong>(Cilta-cel)：另一款获批的BCMA-CAR-T，其CAR结构采用双表位设计。</li>
            <li style="margin-bottom: 8px;"><strong>[[特立妥珠单抗]]</strong>(Teclistamab)：靶向BCMA×CD3的双特异性抗体，与CAR-T在治疗路径上形成互补。</li>
            <li style="margin-bottom: 8px;"><strong>[[MRD]]</strong>：微小残留病。Abecma治疗后的MRD转阴率是评估长期获益的关键指标。</li>
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        <span style="color: #0f172a; font-weight: bold; font-size: 1.05em; display: inline-block; margin-bottom: 15px;">学术参考文献与权威点评</span>
        
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            [1] <strong>Munshi NC, et al. (2021).</strong> <em>Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma.</em> <strong>[[The New England Journal of Medicine]]</strong>.<br>
            <span style="color: #475569;">[权威点评]：该项KarMMa研究确立了Ide-cel在三线以上复发难治患者中的注册审批基石。</span>
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            [2] <strong>Rodriguez-Otero P, et al. (2023).</strong> <em>Ide-cel versus Standard Care in Relapsed and Refractory Multiple Myeloma.</em> <strong>[[The New England Journal of Medicine]]</strong>.[Academic Review]<br>
            <span style="color: #475569;">[学术点评]：KarMMa-3研究证明了将Ide-cel治疗线数前移至二至四线，较标准护理方案可显著延长PFS。</span>
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            Abecma (Ide-cel) 诊疗生态 · 知识图谱
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">关联靶点</td>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[BCMA]]</strong>•<strong>[[CD38]]</strong>•<strong>[[GPRC5D]]</strong>•<strong>[[CD3]]</strong>•<strong>[[4-1BB]]</strong></td>
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">同类/竞争</td>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[西达基奥仑赛]]</strong>•<strong>[[泽沃基奥仑赛]]</strong>•<strong>[[特立妥珠单抗]]</strong>•<strong>[[埃兰妥单抗]]</strong></td>
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">战略实体</td>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[BMS]]</strong>•<strong>[[2seventybio]]</strong>•<strong>[[FDA]]</strong>•<strong>[[NCCN]]</strong>•<strong>[[ASCO]]</strong></td>
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                <td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">前沿方向</td>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[一线诱导后维持治疗]]</strong>•<strong>[[克服靶点下调耐药]]</strong>•<strong>[[全人源CAR结构设计]]</strong>•<strong>[[联合免疫调节剂增效]]</strong></td>
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