A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease

Recruiting now · Phase 1

Conditions studied: Chronic Graft-Versus-Host Disease

In brief

Open-label, dose escalation study to evaluate safety, tolerability pharmacokinetic and pharmacodynamic activity, and efficacy of Adrixetinib (Q702) in subjects with relapsed or refractory active chronic graft-versus-host disease (cGVHD).

Key facts

Study ID

NCT07138196

Run by

Qurient Co., Ltd.

People needed

18

Starts

2025-12-23

Expected to finish

2029-10-31

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are allogeneic HSCT recipients with moderate or severe active cGVHD requiring systemic immune suppression.
• Subjects with relapsed or refractory active cGVHD who have progressed after all available standard of care treatments.
• Subject must have documented progressive disease as defined by the NIH 2014 consensus criteria, in terms of either organ specific algorithm or global assessment, or active, symptomatic cGVHD for which the treating physician believes that a new line of systemic therapy is required.
• Adequate organ and bone marrow functions.
• Karnofsky Performance Scale of ≥ 60.

You may not qualify if…

• Exposure to CSF1R inhibitor therapy for any indication after allogeneic transplant.
• Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer.
• Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment.
• Female subject who is pregnant or breastfeeding.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Where it is running

• Hospital Clinic de Barcelona — Barcelona, Spain (enrolling)
• Hospital General Universitario Gregorio Maranon — Madrid, Spain (enrolling)
• Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Spain (enrolling)
• Hospital Universitario Virgen de la Arrixaca — Murcia, Spain (enrolling)
• Clinica Universidad de Navarra — Pamplona, Spain (enrolling)
• Hospital Universitario Marques de Valdecilla — Santander, Spain (enrolling)
• Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
• Instituto de Investigacion Sanitaria — Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.