NCT07012304RecruitingPhase 1/2
Gecacitinib for cGVHD: Safety and Efficacy in Patients After ≥2 Lines of Prior Therapy
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 9 May 2025
- Start date
- 30 Jun 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Yujun DONG
- NCT number
- NCT07012304
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 24
- From 30 Jun 2025 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of other JAK inhibitors, mesenchymal stem cells, or belumosudil (Eligible if discontinued for \>8 weeks post-aGVHD treatment or stopped JAK inhibitors for cGVHD due to side effects.)
- Surgery within 4 weeks of screening with incomplete recovery
- Herbal medicine use within 1 week prior to enrollment
- Participation in another clinical trial within 4 weeks (or 5 half-lives of the previous study drug, whichever is longer)
Other illness
- Recurrence of malignancy or loss of full donor chimerism
- Post-transplant lymphoproliferative disease
- History of major cardiovascular events within 6 months.
- Arrhythmia requiring treatment at screening
- Gastrointestinal conditions impairing drug absorption
- Active/uncontrolled infections (viral, bacterial, parasitic, fungal) requiring treatment
- Active tuberculosis within 6 months
- Epilepsy or use of psychotropic/sedative drugs
- Malignancy within 5 years (except the indication for transplant)
- Hypersensitivity to gecacitinib or its components
Lab values
- Significant abnormalities affecting safety assessment, such as uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite ≤2 antihypertensives; ALT/AST \>3×ULN; DBIL/TBIL \>1.5×ULN; serum creatinine \>1.5×ULN
- Use of anticoagulants/platelet inhibitors (except low-molecular-weight heparin)
Other
- Severe pulmonary cGVHD (FEV1 ≤39% or NIH lung symptom score of 3)
- Pregnant/breastfeeding or unwilling to use contraception during and 4 weeks post-study
- Deemed unsuitable by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.