NCT07476872

Gecacitinib in the Treatment of Steroid-Refractory/Dependent Chronic Graf Versus Host Disease (cGVHD).

A Single-Arm, Open-Label, Single-Center Phase Ib/IIa Clinical Study of Gecacitinib in the Treatment of Steroid-Refractory/Dependent Active Chronic Graf Versus Host Disease (cGVHD).

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of Gecacitinib in patients with steroid-refractory/dependent active chronic graft versus host disease (cGVHD).

Conditions

• cGVHD
• HSCT

Interventions

Type	Name	Description
DRUG	Gecacitinib	Phase Ib: Four dose cohorts of Gecacitinib are planned: 50 mg qd, 50 mg bid, 150 mg/day, and 100 mg bid. Dose escalation or de-escalation will follow the standard "3+3" design, starting at 50 mg BID. The dose may be escalated to 150 mg/day or 100 mg BID, or de-escalated to 50 mg qd. Subjects will receive continuous dosing for 28 days, or until they experience Dose-Limiting Toxicities (DLTs), cGVHD progression, or initiate new systemic therapy (whichever occurs first). Subjects who do not experience DLTs during Phase Ib may proceed to the Phase IIa dose-expansion stage. Phase IIa: Subjects will receive Gecacitinib at the Recommended Phase II Dose (RP2D). Treatment will continue until the completion of 6 treatment cycles (each cycle is comprised of 4 weeks), or until the occurrence of intolerable toxicity, cGVHD progression, or initiation of new systemic therapy (whichever occurs first).

Timeline

• Start date: 2026-03-16
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2026-03-17
• Last updated: 2026-03-17