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

Launched by YUJUN DONG · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called gecacitinib to see how safe and effective it is for patients with chronic graft-versus-host disease (cGVHD) who have not responded well to at least two previous treatments. cGVHD is a serious condition that can occur after a stem cell transplant, and it can greatly impact a person's quality of life. The trial will involve 24 participants who will take gecacitinib tablets for at least 24 weeks, with the possibility of continuing treatment for up to 60 weeks if their condition remains stable.

To be eligible for this trial, participants must be at least 18 years old, have had a stem cell transplant from any donor source, and have a confirmed diagnosis of moderate to severe cGVHD. They should have already tried two to five other treatments without success. Participants will need to be able to swallow tablets and will undergo regular check-ups to monitor their health. It's important to note that certain health conditions and treatments may exclude someone from participating, so potential participants should discuss their individual situation with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Recurrence of malignancy or loss of full donor chimerism
• • 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.)
• • Severe pulmonary cGVHD (FEV1 ≤39% or NIH lung symptom score of 3)
• • Post-transplant lymphoproliferative disease
• • 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
• • History of major cardiovascular events within 6 months.
• • Arrhythmia requiring treatment at screening
• • Gastrointestinal conditions impairing drug absorption
• • Surgery within 4 weeks of screening with incomplete recovery
• • Active/uncontrolled infections (viral, bacterial, parasitic, fungal) requiring treatment
• • Active tuberculosis within 6 months
• • Epilepsy or use of psychotropic/sedative drugs
• • Pregnant/breastfeeding or unwilling to use contraception during and 4 weeks post-study
• • Malignancy within 5 years (except the indication for transplant)
• • Use of anticoagulants/platelet inhibitors (except low-molecular-weight heparin)
• • Herbal medicine use within 1 week prior to enrollment
• • Hypersensitivity to gecacitinib or its components
• • Participation in another clinical trial within 4 weeks (or 5 half-lives of the previous study drug, whichever is longer)
• • Deemed unsuitable by the investigator