Golidocitinib Combined With Selinexor for CAEBVD

NCT07369739 | Recruiting Phase 2 DMC

• 1 other identifier: GS for CAEBVD
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphohistiocytosis; EBV; CAEBV

Outcome Measures

Primary Outcomes (2)

• Disease Activity

  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.

  Weeks 8 after the start of treatment

• EBV-DNA

  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.

  Weeks 8 after the start of treatment

Other Outcomes (1)

• Survival

  6-month, 1-year and 2-year

Study Arms (1)

Experimental group:CAEBVD

EXPERIMENTAL

Drug: golidocitinib; Drug: Selinexor (combination therapy)

Interventions

golidocitinib DRUG

golidocitinib 150 mg once daily.

Experimental group:CAEBVD

Selinexor (combination therapy) DRUG

selinexor 40 mg once weekly.

Experimental group:CAEBVD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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.

You may not qualify if:

• 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).
• Hypersensitivity to the components of the study drug, or a history of severe allergic diathesis.
• Patients who are unable to comply with the requirements during the trial and/or follow-up phase.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

selinexor; Combined Modality Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jingshi Wang

CONTACT

86-010-80838351; wangjingshi987@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)