CN114053599B - 一种用于肿瘤免疫治疗的药盒 - Google Patents
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Abstract
本发明属于免疫治疗技术领域,涉及一种用于肿瘤免疫治疗的药盒。所述的药盒包含单独包装的或形成组合物的放射性核素标记物、免疫检查点抑制剂以及纳米硅。利用本发明的用于肿瘤免疫治疗的药盒,能够在肿瘤放射免疫治疗时,在提高或保证疗效的基础上减少对靶标外的正常细胞的损害。
Description
技术领域
本发明属于免疫治疗技术领域,涉及一种用于肿瘤免疫治疗的药盒。
背景技术
近年来,随着医疗技术的发展,人类攻克了很多以前无法治愈的疾病,但恶性肿瘤至今仍无法治愈。国际癌症研究中心(IARC)的研究数据表明,2002年全世界恶性肿瘤新发病例约为1090万例,死亡670万例,截止到2020年全世界每年新增癌症病例人数达到1500万人。
大量的临床实践证明,早期诊断和早期治疗相结合可以降低癌症病人死亡率,增加癌症病人存活率,延长其生命。早期的癌症患者通常缺乏比较明显的临床体征,只有通过影像学检查才能初步诊断出来。高分辨分子影像技术PET及SPECT结合高灵敏高特异性的放射性核素标记探针,可从分子水平反映恶性肿瘤病变情况,较基于解剖学形态改变的检测方法能提前无创显示肿瘤的浸润转移生物学行为。在肿瘤靶标方面,通过研究者们不断的研究筛选,建立了基于小分子、大分子以及纳米平台的一系列核素标记探针,为肿瘤的精确诊断和病灶的精确定位提供了强有力的保证。
目前肿瘤治疗的传统方式为:手术治疗、化疗、放射治疗等,近年来还兴起了免疫治疗,一系列免疫检查点抑制剂如CTLA-4抑制剂、PD-1/PD-L1抑制剂等陆续被应用于临床。
免疫治疗(immunotherapy)是指针对机体低下或亢进的免疫状态,人为地增强或抑制机体的免疫功能以达到治疗疾病目的的治疗方法。免疫治疗的方法有很多,适用于多种疾病的治疗。肿瘤的免疫治疗旨在激活人体免疫系统,依靠自身免疫机能杀灭癌细胞和肿瘤组织。与以往的手术、化疗、放疗和靶向治疗不同的是,免疫治疗针对的靶标不是肿瘤细胞和组织,而是人体自身的免疫系统。
放射免疫治疗的治疗效果主要取决于载体的导向性能和核素弹头的杀伤力。核素弹头的杀伤力过大,虽然对正常细胞损害较少,但仍具有一定的损伤,因此需要对靶标外的细胞进行保护。
发明内容
本发明的目的是提供一种用于肿瘤免疫治疗的药盒,以能够在肿瘤放射免疫治疗时,在提高或保证疗效的基础上减少对靶标外的正常细胞的损害。
为实现此目的,在基础的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,所述的药盒包含单独包装的或形成组合物的放射性核素标记物、免疫检查点抑制剂以及纳米硅。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的药盒中放射性核素标记物、免疫检查点抑制剂以及纳米硅之比为35-42MBq:1mg:0.3-0.5mg。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中每克所述的放射性核素标记物中放射性核素的活度为300-500mCi。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的放射性核素标记物中的放射性核素选自131I、177Lu、90Y中的一种或多种。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的放射性核素标记物中的被标记物选自PSMA、EB-TATE或EB-RGD中的一种或多种。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的放射性核素标记物选自177Lu-PSMA、177Lu-EB-TATE或177Lu-EB-RGD中的一种或多种。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的免疫检查点抑制剂选自CTLA-4抑制剂、PD-1/PD-L1抑制剂中的一种或多种。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的CTLA-4抑制剂为Ipilimumab单抗和/或Tremelimumab单抗。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的PD-1/PD-L1抑制剂选自Atezolizumab单抗、Durvalumab单抗、Nivolumab单抗、Pembrolizumab单抗、Camrelizumab单抗、Sintilimab单抗中的一种或多种。
在一种优选的实施方案中,本发明提供一种用于肿瘤免疫治疗的药盒,其中所述的纳米硅的平均粒度为10-100nm。
本发明的有益效果在于,利用本发明的用于肿瘤免疫治疗的药盒,能够在肿瘤放射免疫治疗时,在提高或保证疗效的基础上减少对靶标外的正常细胞的损害。
本发明的用于肿瘤免疫治疗的药盒进入人体后,可通过纳米硅溶于水提供氢气,对辐射损伤细胞有保护作用,可以减轻放射性治疗药物的副作用,为后续肿瘤免疫治疗、放射性治疗提供新的思路。
具体实施方式
下面将结合实施例对本发明进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
本发明提供了一种用于肿瘤免疫治疗的药盒,包括:放射性核素标记物、免疫检查点抑制剂以及纳米硅。放射性核素标记物、免疫检查点抑制剂以及纳米硅之比为35-42MBq:1mg:0.3-0.5mg。
其中,放射性核素标记物为177Lu-PSMA、177Lu-EB-TATE或177Lu-EB-RGD中的任意一种,免疫检查点抑制剂为PD-L1抑制剂,PD-L1抑制剂为Atezolizumab单抗(阿特珠单抗)或Durvalumab单抗(德瓦鲁单抗)。
以下实施例公开了177Lu放射性核素标记物,结合PD-L1抑制剂用于治疗前列腺瘤等。在其他实施例中,也可选择其余放射性核素标记物以及与放射性核素配合的免疫检查点抑制剂来制备药盒,进而适用于不同的肿瘤治疗。
其余放射性核素可选择131I、90Y等。免疫检查点抑制剂可选择CTLA-4抑制剂、PD-1抑制剂等,CTLA-4抑制剂包括Ipilimumab单抗(伊匹单抗)、Tremelimumab抗体(替西木单抗)等;PD-1抑制剂包括Nivolumab单抗(纳武利尤单抗)、Pembrolizumab单抗(派姆单抗)、Camrelizumab抗体(卡瑞利珠单抗)、Sintilimab抗体(信迪利单抗)等。
以下实施例用于制备一种应用于前列腺肿瘤免疫治疗的药盒,药盒中,纳米硅与放射性核素标记物混合均匀后包装,免疫检查点抑制剂单独包装。给药量为:患者体重每kg给药放射性核素标记物35-42MBq、免疫检查点抑制剂1mg、纳米硅0.3-0.5mg。
实施例1:
患者体重60kg,给药量为:放射性核素标记物2100MBq、免疫检查点抑制剂60mg、纳米硅18mg。
实施例2:
患者体重70kg,给药量为:放射性核素标记物2800MBq、免疫检查点抑制剂70mg、纳米硅28mg。
实施例3:
患者体重80kg,给药量为:放射性核素标记物3360MBq、免疫检查点抑制剂80mg、纳米硅40mg。
使用实施例1-3的药盒时,首先注射放射性核素标记物与纳米硅的混合物,在放射性核素进入体内重塑肿瘤免疫微环境,提高病灶部位的免疫反应的同时,通过纳米硅进入体内溶于水提供氢气,对核素辐射损伤后附近的正常细胞提供一定的保护作用。3-4小时后,再注射免疫检查点抑制剂进行肿瘤免疫治疗。
药物进入人体后,可通过纳米硅溶于水提供氢气,对辐射损伤细胞有保护作用,可以减轻放射性治疗药物的副作用。本发明为后续肿瘤免疫治疗、放射性治疗提供了新的思路。
上述实施例只是对本发明的举例说明,本发明也可以以其它的特定方式或其它的特定形式实施,而不偏离本发明的要旨或本质特征。因此,描述的实施方式从任何方面来看均应视为说明性而非限定性的。本发明的范围应由附加的权利要求说明,任何与权利要求的意图和范围等效的变化也应包含在本发明的范围内。
Claims (8)
1.一种用于肿瘤免疫治疗的药盒,其特征在于:所述的药盒包含放射性核素标记物、免疫检查点抑制剂以及纳米硅;
所述的药盒中放射性核素标记物、免疫检查点抑制剂以及纳米硅之比为42MBq:1mg:0.5mg;
所述的纳米硅的平均粒度为10-100nm;
药盒中,所述纳米硅与所述放射性核素标记物混合均匀后包装,所述免疫检查点抑制剂单独包装;
使用药盒时,首先注射放射性核素标记物与纳米硅的混合物,在放射性核素进入体内重塑肿瘤免疫微环境,提高病灶部位的免疫反应的同时,通过纳米硅进入体内溶于水提供氢气,对核素辐射损伤后附近的正常细胞提供一定的保护作用,3-4小时后,再注射免疫检查点抑制剂进行肿瘤免疫治疗。
2.根据权利要求1所述的药盒,其特征在于:每克所述的放射性核素标记物中放射性核素的活度为300-500mCi。
3.根据权利要求1-2之一所述的药盒,其特征在于:所述的放射性核素标记物中的放射性核素选自131I、177Lu、90Y中的一种或多种。
4.根据权利要求1-2之一所述的药盒,其特征在于:所述的放射性核素标记物中的被标记物选自PSMA、EB-TATE或EB-RGD中的一种或多种。
5.根据权利要求1-2之一所述的药盒,其特征在于:所述的放射性核素标记物选自177Lu-PSMA、177Lu-EB-TATE或177Lu-EB-RGD中的一种或多种。
6.根据权利要求1-2之一所述的药盒,其特征在于:所述的免疫检查点抑制剂选自CTLA-4抑制剂、PD-1/PD-L1抑制剂中的一种或多种。
7.根据权利要求6所述的药盒,其特征在于:所述的CTLA-4抑制剂为Ipilimumab单抗和/或Tremelimumab单抗。
8.根据权利要求6所述的药盒,其特征在于:所述的PD-1/PD-L1抑制剂选自Atezolizumab单抗、Durvalumab单抗、Nivolumab单抗、Pembrolizumab单抗、Camrelizumab单抗、Sintilimab单抗中的一种或多种。
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