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Clinical Trials in China / NCT07369739
Recruiting Phase 2/3

Golidocitinib Combined With Selinexor for CAEBVD

NCT07369739 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Friendship Hospital
Phase
Phase 2/3
Started
2026-01-01
Last updated
2026-01-27

Condition(s) studied

LymphohistiocytosisEBVCAEBV

Investigational drug(s) / intervention(s)

golidocitinib →Selinexor (combination therapy) →

golidocitinib: golidocitinib 150 mg once daily.

Selinexor (combination therapy): selinexor 40 mg once weekly.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. CAEBVD diagnosed in accordance with the Consensus on the Diagnosis and Treatment of Chronic Active Epstein-Barr Virus Disease (2025 Edition). 2. Aged ≥ 18 years and ≤ 70 years, regardless of gender. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. 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. 5. Routine blood test: absolute neutrophil count ≥ 1 × 10#/L; platelet count ≥ 50 × 10#/L; hemoglobin ≥ 60 g/L. 6. Coagulation function test requirements: international normalized ratio (INR) ≤ 2.0; prothrombin time (PT) ≤ 1.5 × ULN. 7. 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. 8. Signed informed consent form. Exclusion Criteria: 1. 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. 2. 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. 3. 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). 4. A history of organ transplantation (e.g., liver transplantation, kidney transplantation). 5. Planned hematopoietic stem cell transplantation during the study period. 6. 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. 7. Having undergone major surgery within 4 weeks prior to the first dose, or anticipating the need for major surgery during the study period. 8. Pregnant or lactating women. 9. A history of severe mental illness or drug abuse. 10. Uncontrolled infections (including pulmonary infection, intestinal infection); active major visceral hemorrhage (including gastrointestinal bleeding, alveolar hemorrhage, intracranial hemorrhage). 11. Hypersensitivity to the components of the study drug, or a history of severe allergic diathesis. 12. Patients who are unable to comply with the requirements during the trial and/or follow-up phase.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Friendship Hospital Beijing China Recruiting

More Beijing Friendship Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07369739 on ClinicalTrials.gov ↗ ← All trials in China