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A multicenter, open-label, single-arm, phase Ib clinical trial of HH2853 treatment in patients with relapsed and/or refractory peripheral T-cell lymphoma

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资源类型：
Pubmed体系：
作者：
Hong Huangming[1] * ; Chen Zegeng[2] * ; Zhang Mingzhi[3] * ; Peng Zhigang[4] * ; Shen Jianzhen[5] ; Shuang Yuerong[6] ; Zhou Hui[7] ; Guo Hongqiang[8] ; Huang He[2] ; Li Fei[9] ; Qian Zhengzi[10] ; Liu Lihong[11] ; Wang Liang[12] ; Yang Wei[13] ; Zhang Liling[14] ; He Pengcheng[15] ; Qian Shen[16] ; Li Fugen[16] ; Li Meng[16] ; Lin Tongyu[1,2] ;
机构： [1]Department of Medical Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, No.55, Section 4, South Renmin Road, Chengdu, China [2]State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China [3]Lymphoma Diagnosis and Treatment Center of Henan Province, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China [4]The First Affiliated Hospital of Guangxi Medical University, Nanning, China [5]Fujian Medical University Union Hospital, Fuzhou, China [6]Jiangxi Cancer Hospital, Nanchang, China [7]Hunan Cancer Hospital, Changsha, China [8]Henan Cancer Hospital, Zhengzhou, China [9]The First Affiliated Hospital of Nanchang University, Nanchang, China [10]Tianjin Medical University Cancer Institute and Hospital, Tianjin, China [11]The Fourth Hospital of Hebei Medical University, Shijiazhuang, China [12]Beijing Tongren Hospital, Beijing, China [13]Shengjing Hospital of China Medical University, Shenyang, China [14]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [15]The First Affiliated Hospital of Xi’an Jiaotong University, Xian, China [16]Haihe Biopharma Co., Ltd., Shanghai, China
出处：
DOI： 10.1186/s13045-025-01697-z

关键词： Peripheral T-cell lymphoma EZH1/2 HH2853

摘要：
Peripheral T-cell lymphoma (PTCL) is an aggressive malignancy with limited treatment options and poor prognosis, particularly for relapsed or refractory (r/r) patients. HH2853, a novel dual inhibitor of EZH1/2, has previously demonstrated clinical benefits in solid tumors. Here, we report safety and efficacy data from a phase Ib trial of HH2853 in r/r PTCL.A phase Ib clinical trial in PTCL was conducted from July 2022-August 2023 at 15 sites in China. The study employed a dose-escalation phase (300 mg, 400 mg, and 600 mg BID) to determine the recommended phase II dosage (RP2D), followed by a dose expansion phase (300 mg and 400 mg BID). The primary endpoints were safety and the overall response rate (ORR).Thirty-four patients with various r/r PTCL histology types, a median age of 58 years, and a median of 2 prior systemic therapies were enrolled. Treatment-related adverse events (TRAEs) were observed in 92.1% of the patients, with 20.6% experiencing grade 3 TRAEs. The most common TRAEs included anemia (67.6%), thrombocytopenia (52.9%), leukopenia (44.1%), and diarrhea (38.2%). One patient (2.9%) receiving 600 mg BID experienced dose-limiting toxicity due to grade 4 thrombocytopenia. The dose of 400 mg BID was selected as the RP2D. The ORR was 67.6%, comprising 29.4% complete remission and 38.2% partial remission. As of the data cutoff in September 2024, the median follow-up period was 15.7 months, with a median duration of response of 14.8 months; overall survival had not yet been reached.The selective EZH1/2 dual inhibitor HH2853 demonstrated acceptable and manageable safety profiles and promising efficacy in r/r PTCL patients, indicating its therapeutic potential for this difficult-to-treat patient population.NCT04390737.© 2025. The Author(s).

基金：
This work is supported by National Natural Science Foundation of China (82270198 to Huangming Hong and 82470237 to Tongyu Lin), Cancer Innovative Research Program of Sun Yat-sen University Cancer Center (CIRP-SYSUCC-0022 to Tongyu Lin).
语种：
外文
PubmedID：
中科院分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 血液学 1 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 血液学 1 区 肿瘤学
第一作者：
第一作者机构： [1]Department of Medical Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, No.55, Section 4, South Renmin Road, Chengdu, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Medical Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, No.55, Section 4, South Renmin Road, Chengdu, China [2]State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China
推荐引用方式(GB/T 7714)：
Hong Huangming,Chen Zegeng,Zhang Mingzhi,et al.A multicenter, open-label, single-arm, phase Ib clinical trial of HH2853 treatment in patients with relapsed and/or refractory peripheral T-cell lymphoma[J].Journal Of Hematology & Oncology.2025,18(1):50.doi:10.1186/s13045-025-01697-z.
APA：
Hong Huangming,Chen Zegeng,Zhang Mingzhi,Peng Zhigang,Shen Jianzhen...&Lin Tongyu.(2025).A multicenter, open-label, single-arm, phase Ib clinical trial of HH2853 treatment in patients with relapsed and/or refractory peripheral T-cell lymphoma.Journal Of Hematology & Oncology,18,(1)
MLA：
Hong Huangming,et al."A multicenter, open-label, single-arm, phase Ib clinical trial of HH2853 treatment in patients with relapsed and/or refractory peripheral T-cell lymphoma".Journal Of Hematology & Oncology 18..1(2025):50

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