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

NCT07476872 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-17

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2027-11-01
Completion
2028-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07476872 on ClinicalTrials.gov