An Exploratory Clinical Study on the Efficacy and Safety of Humanized CD25 Monoclonal Antibody Combined With Glucocorticoid in the First-line Treatment of Acute Graft-versus-host Disease (aGVHD) After Allo-HSCT

The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.

开始日期2024-07-01

申办/合作机构

中国医学科学院血液病医院

100 项与 Humanized CD25 Monoclonal Antibody(Institute of Hematology & Blood Diseases Hospital) 相关的临床结果

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100 项与 Humanized CD25 Monoclonal Antibody(Institute of Hematology & Blood Diseases Hospital) 相关的转化医学

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100 项与 Humanized CD25 Monoclonal Antibody(Institute of Hematology & Blood Diseases Hospital) 相关的专利（医药）

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项与 Humanized CD25 Monoclonal Antibody(Institute of Hematology & Blood Diseases Hospital) 相关的文献（医药）

2023-09-14·Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi

[Humanized anti-CD25 monoclonal antibody as a salvage therapy for steroid-refractory acute graft-versus-host disease after hematopoietic stem cell transplantation].

Article

作者: Hou, M J ; Jiang, S S ; Wang, X ; Wu, D P ; Liu, B ; Ma, X ; Wu, Y X ; Wu, Y B ; Hu, X H ; Jing, Y T ; Li, Q

目的： 分析重组抗CD25人源化单克隆抗体（人源化CD25单抗）治疗异基因造血干细胞移植后糖皮质激素耐药型急性移植物抗宿主病（SR-aGVHD）的疗效。 方法： 纳入2019年6月至2020年10月在苏州弘慈血液病医院接受人源化CD25单抗治疗的64例异基因造血干细胞移植后SR-aGVHD患者，所有患者予人源化CD25单抗1 mg·kg(-1)·d(-1)第1、3、8天各1次，此后根据病情每周1次。在人源化CD25单抗治疗后第7、14、28天进行疗效评估。 结果： 64例患者中男38例（59.4%），女26例（40.6%），中位年龄31（15~63）岁。64例SR-aGVHD患者人源化CD25单抗治疗后第7、14、28天有效率分别为48.4%（31/64）、53.1%（34/64）、79.7%（51/64）。肝脏受累是人源化CD25单抗治疗SR-aGVHD第28天疗效不佳的独立危险因素（OR＝9.588，95%CI 0.004~0.291，P＝0.002）。从人源化CD25单抗治疗开始随访，所有患者的中位随访时间为17.1（0.2~50.8）个月。治疗后12、24个月总生存率分别为63.2%（95%CI 57.1%~69.3%）、52.6%（95%CI 46.1%~59.1%），无病生存率分别为58.4%（95%CI 52.1%~64.7%）、49.8%（95%CI 43.4%~56.2%），非复发死亡率分别为28.8%（95%CI 23.1%~34.5%）、32.9%（95%CI 26.8%~39.0%）。多因素分析结果显示，肝脏受累（OR＝0.308，95%CI 0.108~0.876，P＝0.027）和Ⅲ/Ⅵ度aGVHD（OR＝9.438，95%CI 1.211~73.577，P＝0.032）是影响移植后总生存的独立危险因素。 结论： 人源化CD25单抗对于异基因造血干细胞移植后SR-aGVHD有较好的疗效。.

2007-02-01·Zhongguo shi yan xue ye xue za zhi

[Effects of humanized recombinant CD25 monoclonal antibody on activation and proliferation of t lymphocytes].

Article

作者: Ren, Han-Yun ; Liu, Wei

The study was purposed to investigate the effects of humanized recombined CD25 monoclonal antibody (rhCD25MAb) on activation and proliferation of T lymphocytes in vitro. Peripheral blood mononuclear cells (PBMNC) were incubated with phytohemagglutinin (PHA). Before or after T cell activation, the cells were cultured with or without rhCD25MAb or cyclosporine A (CsA) in vitro. After 72 hours incubation, the proliferation of lymphocytes was analyzed by MTT assay. The expression of CD3 and CD25 antigens on T lymphocytes were detected by flow cytometry. The levels of sIL-2R in the supernatants were determined with ELISA. The results showed that both rhCD25MAb and CsA could inhibit the proliferation of T lymphocytes significantly in concentration-dependent manner and CsA was more efficient than rhCD25MAb. Both rhCD25MAb and CsA could also decrease the levels of sIL-2R in the supernatant and inhibit the expression of CD25 antigen on T lymphocytes. The level of sIL-2R and the expression of CD25 on T lymphocytes decreases more profoundly in rhCD25MAb group. It is concluded that rhCD25MAb shows strong immunosuppressive activity both before and after T cell activation, suggesting that this agent may be useful in not only prophylaxis but also the treatment of acute graft-versus-host disease.

2003-02-10·Zhonghua yi xue za zhi

[Treatment of severe steroid-refractory graft-versus-host disease with IL-2R alpha chain (CD25) monoclonal antibody].

Article

作者: Chen, Huan ; Ren, Han-yun ; Xu, Lan-ping ; Huang, Xiao-jun ; Lu, Dao-pei ; Guo, Nai-lan ; Lu, Jin ; Zhang, Yao-chen

OBJECTIVETo investigate the effects of IL-2R alpha chain (CD(25)) monoclonal antibody on severe steroid-refractory graft-versus-host disease (GVHD).METHODSSeventeen patients (18 times) with severe steroid-refractory GVHD were treated with intravenous drip of humanized CD(25) monoclonal antibody on day 1, 3 or 4, 8, 15 and 22. The cumulative scoring of GVHD and status of infection were observed, and laboratory tests, including blood counting and blood biochemical test were made before and 1, 4, 8, 15, 22, 29, 36, 43 and 50 days after the treatment.RESULTS(1) Eleven of the eighteen case-times (61.1%) got complete relief, five (27.8%) GVHD got partial relief, and two (11.1%) failed to get relief. (2) Seven case-times (33.3%) had infection. (3) Relapse of GVHD occurred in four of the eleven case-times with complete relief (36.4%). (4) No infusion-related reaction was observed.CONCLUSIONThe monoclonal antibody against IL-2 receptor alpha chain (CD(25)) has a marked effect upon severe steroid-refractory GVHD.

100 项与 Humanized CD25 Monoclonal Antibody(Institute of Hematology & Blood Diseases Hospital) 相关的药物交易

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