Golidocitinib plus selinexor for chronic active Epstein‑Barr virus disease (CAEBVD)

Golidocitinib Combined With Selinexor for the Treatment of Chronic Active Epstein-Barr Virus Disease (CAEBVD): A Multicenter, Prospective, Single-arm Clinical Study

This trial will try combining golidocitinib and selinexor to treat adults aged 18–70 with chronic active Epstein‑Barr virus disease, including EBV‑associated lymphohistiocytosis.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Drugs / interventions: golidocitinib
• Locations: 1 site (Beijing)
• Trial ID: NCT07369739 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, single‑arm Phase 2/3 trial gives adults with CAEBVD a combined regimen of golidocitinib and selinexor and follows them to measure response and safety. Eligible patients must meet the 2025 diagnostic consensus for CAEBVD and have ECOG 0–1 and acceptable liver, kidney, blood, and coagulation tests. All enrolled participants receive the combination therapy and undergo regular clinical assessments, laboratory monitoring, and imaging as specified in the protocol. Primary endpoints focus on disease response and tolerability, with secondary endpoints including duration of response and progression to further therapies.

Who should consider this trial

Good fit: Adults 18–70 years old with confirmed CAEBVD, good performance status (ECOG 0–1), and adequate organ and blood function who can comply with trial procedures are ideal candidates.

Not a fit: Patients with poor performance status, significant liver or kidney dysfunction, uncontrolled infections, pregnant individuals or those unwilling to use contraception, or those outside the age or lab criteria are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, the combination could improve control of EBV‑driven disease and reduce symptoms or the need for more intensive treatments such as hematopoietic stem cell transplant.

How similar studies have performed: This specific drug combination is novel for CAEBVD and has limited prior data in this disease, though each agent has shown activity in related hematologic or inflammatory conditions.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Friendship Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jingshi Wang

Conditions Lymphohistiocytosis; EBV; CAEBV