Clinical Trial

Gecacitinib for cGVHD: Safety and Efficacy in Patients After ≥2 Lines of Prior Therapy

Recruiting Phase 1/2
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Summary
Chronic Graft-versus-Host Disease (cGVHD) is a common late complication following allogeneic hematopoietic stem cell transplantation and a leading non-relapse cause of death. It is often treatment-refractory, significantly affecting patients' quality of life and prognosis. This study will evaluate the feasibility, safety, and tolerability of gecacitinib, a novel JAK and ACVR1 inhibitor, in 24 patients with moderate-to-severe cGVHD who have undergone two or more prior therapies. Participants will receive gecacitinib hydrochloride tablets for at least 24 weeks. Patients demonstrating disease stability, as assessed by the investigator, may continue treatment with the study drug until week 60, unless intolerability, disease progression, or initiation of new systemic therapy, whichever occurs first.
Trial Details
NCT Number NCT07012304
Lead Sponsor Yujun DONG
Conditions Chronic Graft Versus Host Disease
Enrollment 24 participants
Start Date 2025-06-30
Primary Completion 2027-02-28 (estimated)
Study Completion 2029-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-06-10