NCT07369739
招募中
2 期
Golidocitinib Combined With Selinexor for the Treatment of Chronic Active Epstein-Barr Virus Disease (CAEBVD): A Multicenter, Prospective, Single-arm Clinical Study
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Disease Activity
概览
简要总结
This study is a multicenter, prospective, single-arm clinical investigation, with patients with CAEBVD as the main research subjects, to evaluate the effectiveness of the combined treatment regimen of golidocitinib and selinexor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CAEBVD diagnosed in accordance with the Consensus on the Diagnosis and Treatment of Chronic Active Epstein-Barr Virus Disease (2025 Edition).
- •Aged ≥ 18 years and ≤ 70 years, regardless of gender.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Before the initiation of the study, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN.
- •Routine blood test: absolute neutrophil count ≥ 1 × 10#/L; platelet count ≥ 50 × 10#/L; hemoglobin ≥ 60 g/L.
- •Coagulation function test requirements: international normalized ratio (INR) ≤ 2.0; prothrombin time (PT) ≤ 1.5 × ULN.
- •Women of childbearing potential must have a negative pregnancy test result, and be willing to take effective contraceptive measures during the trial period and for ≥ 12 months after the last dose; all male subjects must take contraceptive measures during the trial period and for ≥ 6 months after the last dose.
- •Signed informed consent form.
排除标准
- •Evidence of EBV-associated hematological diseases or malignancies, such as hemophagocytic lymphohistiocytosis, lymphomatoid granulomatosis, post-transplant lymphoproliferative disorder, non-Hodgkin's lymphoma, Burkitt lymphoma, nasopharyngeal carcinoma, and gastric cancer.
- •Having received any of the following treatments: prior treatment with any JAK inhibitor; administration of any investigational drug within 12 weeks prior to the first dose of the study drug; concurrent enrollment in another clinical study.
- •A history of other primary malignancies within 5 years prior to the first dose of the study drug, excluding locally curable malignancies that have received curative treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
- •A history of organ transplantation (e.g., liver transplantation, kidney transplantation).
- •Planned hematopoietic stem cell transplantation during the study period.
- •Active hepatitis B (defined as positive hepatitis B surface antigen \[HBsAg\] at screening, or a peripheral blood hepatitis B virus DNA titer \> 1×10³ copies/mL); active hepatitis C (defined as positive anti-hepatitis C virus antibody \[HCV-Ab\] and HCV-RNA at screening); positive serum HIV antigen or antibody; a history of syphilis.
- •Having undergone major surgery within 4 weeks prior to the first dose, or anticipating the need for major surgery during the study period.
- •Pregnant or lactating women.
- •A history of severe mental illness or drug abuse.
- •Uncontrolled infections (including pulmonary infection, intestinal infection); active major visceral hemorrhage (including gastrointestinal bleeding, alveolar hemorrhage, intracranial hemorrhage).
研究组 & 干预措施
Experimental group:CAEBVD
Experimental
干预措施: Selinexor (combination therapy) (Drug)
Experimental group:CAEBVD
Experimental
干预措施: golidocitinib (Drug)
结局指标
主要结局
Disease Activity
时间窗: Weeks 8 after the start of treatment
Patients are classified into active and inactive phases based on their clinical symptoms, signs, and laboratory tests.Disease activity is defined as the presence of CAEBVD-related symptoms and signs.
EBV-DNA
时间窗: Weeks 8 after the start of treatment
The decline rate of EBV-DNA copy number in peripheral blood mononuclear cells (PBMCs)/plasma (defined as a 2-log reduction in EBV-DNA copy number) or conversion to negative.
次要结局
未报告次要终点
研究者
Zhao Wang
doctor
Beijing Friendship Hospital
研究点 (1)
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