高级检索
当前位置: 首页 > 详情页

Ksd-101 in Patients with EBV-Associated Hematologic Neoplasms: Results from an Ongoing Phase I Clinical Study

文献详情

资源类型:
WOS体系:

收录情况: ◇ SCIE ◇ CPCI(ISTP) ◇ 自然指数

单位: [1]Huazhong Univ Sci & Technol, Inst Hematolog, Tongji Med Coll, Tongji Hosp, Wuhan, Peoples R China [2]Huazhong Univ Sci & Technol, Tongji Hosp, Dept Hematol, Tongji Med Coll, Wuhan, Peoples R China [3]Natl Hosp Org Kyushu Canc Ctr, Clin Res Inst, Tumor Cell Biol, Fukuoka, Japan [4]KOUSAI Bio Co Ltd, Shanghai, Peoples R China [5]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan, Peoples R China
出处:
ISSN:

摘要:
Background: The Epstein-Barr Virus (EBV), which has been confirmed by WHO as the first human tumor-associated virus, is a lifelong carrier once infected. EBV-associated Hematologic Neoplasms seriously threats human health, with rapid disease progression, poor prognosis, easy to relapse, and high mortality rate. KSD-101 is a First-in-class autologous dendritic cell (DC) vaccine which is developed to control EBV-associated hematological diseases. Autologous DCs were loaded with the EBV-transformed B-LCL (B-Lymphoblastoid Cell Line) lysates which contains a broad-spectrum EBV antigen to prepare KSD-101 for the treatment of EBV-associated diseases. Methods: In this study, patients (pts) with EBV-associated Hematologic Neoplasms who fail to respond to or relapse after conventional treatment will be recruited and undergo leukapheresis to collect autologous peripheral blood mononuclear cell (PBMC). The enriched monocytes will be induced to differentiate into DCs and prepared as KSD-101 after loading with EBV-transformed B-LCL. Pts will undergo monotherapy with KSD-101, without the need for pre-treatment of lymphodepletion or prophylactic medication. Administration route of KSD-101 is subcutaneous injection, once every 2 weeks for 3-5 vaccinations in total. The study used a 3+3 dose-escalation design. Safety assessment is conducted according to NCI-CTCAE 5.0 grading criteria. The primary objective is to assess the tolerability and safety of KSD-101 in the treatment of EBV-associated Hematologic Neoplasms, explore the dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD). The secondary objective is to explore the clinical efficacy and immune responses of KSD-101 in the patients with EBV-associated Hematologic Neoplasms.

语种:
WOS:
中科院(CAS)分区:
出版当年[2022]版:
大类 | 1 区 医学
小类 | 1 区 血液学
最新[2025]版:
大类 | 1 区 医学
小类 | 1 区 血液学
JCR分区:
出版当年[2021]版:
Q1 HEMATOLOGY
最新[2024]版:
Q1 HEMATOLOGY

影响因子: 最新[2024版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者:
第一作者单位: [1]Huazhong Univ Sci & Technol, Inst Hematolog, Tongji Med Coll, Tongji Hosp, Wuhan, Peoples R China [2]Huazhong Univ Sci & Technol, Tongji Hosp, Dept Hematol, Tongji Med Coll, Wuhan, Peoples R China
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:622 今日访问量:0 总访问量:452 更新日期:2025-07-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)