Status:
RECRUITING
A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease
Lead Sponsor:
Qurient Co., Ltd.
Conditions:
Chronic Graft-Versus-Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 chron...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07138196
Start Date
December 23 2025
End Date
October 31 2029
Last Update
December 30 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clinic de Barcelona
Barcelona, Spain
2
Hospital General Universitario Gregorio Maranon
Madrid, Spain
3
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
4
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain