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招募患者:首都医科大学附属友谊医院CD19 CAR-T细胞免疫治疗免费患者招募

2017-02-21 佚名 马力喏生物

首都医科大学附属友谊医院正在开展一项名为“CD19 CAR T细胞在复发/难治CD19阳性B细胞恶性肿瘤的安全和有效性临床研究”。本项研究已经获得友谊医院医学伦理会员会的批准,现在公开招募受试者。

首都医科大学附属友谊医院正在开展一项名为“CD19 CAR T细胞在复发/难治CD19阳性B细胞恶性肿瘤的安全和有效性临床研究”。本项研究已经获得友谊医院医学伦理会员会的批准,现在公开招募受试者。

适应症

难治/复发B细胞恶性肿瘤(白血病、淋巴瘤)。

CAR T细胞治疗过程


(1)采集患者外周血单个核细胞(PBMC);

(2)CAR T细胞制备(需14天);

(3)预化疗;

(4)CAR T细胞回输;

(5)CAR T细胞体内活性分析;

(6)疗效评估(细胞回输后第28天)

(7)随访

入组标准

(1)CD19阳性复发/难治B细胞恶性肿瘤患者;

(2)白血病取得CR后首次或多次复发;

(3)难治性白血病,即经过2次标准诱导缓解化疗方案后疗效不佳;

(4)没有条件接受造血干细胞移植或造血干细胞移植后复发(HSCT)。在筛查时须HSCT结束后100天,而且免疫抑制疗程结束1个月以上,无活动性移植物抗宿主反应;

(5)Ph+的B-ALL患者,如果不适合酪氨酸激酶抑制剂(tyrosine kinase inhibitor, TKI)治疗,或TKI耐受,或者一线TKI治疗后疾病发生进展;

(6)B细胞淋巴瘤患者既往接受≥两线标准方案化疗,疾病出现进展

说明

参加研究可能的获益:

1. 免费获得抗CD19 CAR T细胞治疗;

2. 免费治疗因本研究带来的任何不良反应;

3.您的疾病可能得到缓解或者控制;

4.在研究期间接受严密的医学观察。

参加该项研究可能出现的不良反应:

1.细胞因子释放综合症

表现:发热、乏力、低血压、呼吸困难

处理:对症治疗;IL-6受体拮抗剂(Tocilizumab,托珠单抗),激素类治疗。必要时,启动自杀基因,快速清除CAR T细胞。

2.免疫球蛋白下降

对于CD19 CAR T细胞治疗后出现免疫球蛋白下降的患者,即使不补充免疫球蛋白,也不会出现与之有关的副作用。

对于个别患者,可以通过静脉输注补充免疫球蛋白,使其浓度维持在安全水平。

受试者有权在研究中途退出研究!

技术说明

抗CD19 CART是目前新兴的基因工程改造自体T细胞免疫治疗技术。多家研究中心获得的结果都证明,CD19 CAR T细胞在治疗复发/难治急性B淋巴细胞白血病可取得高达90%的完全缓解率,6个月无复发生存期(RFS)可达76%,12个月总生存期为79%,而且有的患者在治疗后43个月仍然没有复发。

CD19 CAR T细胞在治疗B细胞淋巴瘤也取得了非常好的结果。根据2016年6月美国科学家Carl June 博士在美国临床肿瘤学会(ASCO)的报道,52%的复发或者耐药的淋巴瘤患者在CD19 CAR T细胞治疗后取得了安全缓解(也就是肿瘤全部消退),其中弥漫大B细胞淋巴瘤患者的完全缓解率为40%,而滤泡性淋巴瘤的完全缓解率为69%。而且,治疗后跟踪至14月时,所有取得完全缓解的患者都没有复发。

这些研究证明,CD19 CAR T细胞不仅可以取得非常理想的完全缓解率,而且还能达到长期控制肿瘤,防止复发的治疗效果。


研究负责人及科室介绍

该项研究由首都医科大学附属友谊医院王昭主任带领。王昭主任从2001年4月至2002年9月在美国国立卫生研究院及美国密歇根大学医学院学习造血干细胞移植和血液病转基因技术。现任中华医学会北京分会血液学专业委员会副主任委员,中华医学会淋巴瘤白血病血液组噬血细胞综合征研究小组学术带头人。多年来致力于噬血细胞综合征的临床和基础研究,率先在国内开展噬血细胞综合征相关突变基因的筛查工作,对噬血细胞综合征的临床诊断、治疗以及实验室检测手段进行了深入研究,提出新的诊疗观点。近年来获得多项与噬血细胞综合征相关的科研基金资助。同时擅长自体和异基因造血干细胞移植、移植物抗宿主病的防治以及各种血液系统恶性肿瘤的临床诊治。

研究单位:首都医科大学附属友谊医院血液科

联系人:魏娜

电话:15011599862

邮箱:applewei80@sohu.com

技术提供:北京马力喏生物科技有限公司

入组及咨询:

联系人:于雪云

电话:15811305018

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    2017-02-23 dingxiaobo
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