A Study on the Safety and Efficacy of Gecacitinib in Patients With Chronic Graft-versus-Host Disease (cGVHD) Who Have Received Prior Treatment With Two or More Systemic Therapies

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Voluntarily Signed informed consent and aged ≥18 years

• Undergone nonmyeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow, peripheral blood stem cells, or umbilical cord blood from any donor source

• Confirmed myeloid and platelet engraftment: ANC \>1.0×10⁹/L and platelet count \>25×10⁹/L; no hematopoietic growth factors or blood product transfusions within 7 days before screening

• Clinically diagnosed moderate-to-severe cGVHD according to the 2014 NIH

• Received 2-5 prior systemic cGVHD therapies with persistent disease

• ECOG PS score of 0-2

• Able to swallow tablets

• Concomitant use of non-interacting immunosuppressants permitted

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 24
Treatments
Experimental: Gecacitinib
Sponsors
Leads: Yujun DONG

This content was sourced from clinicaltrials.gov