Gecacitinib treatment for moderate-to-severe chronic GVHD after two or more prior therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, single-site, interventional study will enroll 24 adults with moderate-to-severe chronic graft-versus-host disease who previously received two to five systemic therapies. Participants will take gecacitinib hydrochloride tablets for a minimum of 24 weeks, with the option to continue treatment up to 60 weeks if the investigator judges the disease stable and the drug is tolerated. The study focuses on feasibility, safety, and tolerability of this dual JAK/ACVR1 inhibitor in a treatment-refractory population and will monitor clinical status and adverse events throughout dosing. Concomitant non-interacting immunosuppressants are allowed under protocol-specified conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.