Recruiting

Adrixetinib for Relapsed or Refractory cGVHD

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What is being tested

Adrixetinib

Drug
Who is being recruted

Bronchiolitis Obliterans Syndrome+8

+ Organizing Pneumonia

+ Bronchial Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorQurient Co., Ltd.
Study ContactQurient Clinical Trial Information
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 23, 2025

Actual date on which the first participant was enrolled.

This study aims to explore a new treatment called Adrixetinib (Q702) for individuals who are experiencing chronic graft-versus-host disease (cGVHD) that has not responded to previous treatments. cGVHD is a condition that can occur in people who have undergone a stem cell transplant, where the donated cells attack the recipient’s body. This study is significant as it seeks to provide a new option for those who have limited treatment choices, potentially improving their quality of life by managing the disease more effectively. Participants in this study will receive the medication orally, and researchers will gradually increase the dosage to find the safest and most effective amount. Throughout the study, the safety and tolerability of Adrixetinib will be closely monitored, along with how the body processes the drug. The study will also look at its effects on the disease itself. By carefully observing these factors, the study aims to determine if Adrixetinib can be a viable treatment option for cGVHD.

Official TitleA Phase 1b, Open-label Dose Escalation Study to Evaluate the Safety, Pharmacodynamic, Pharmacokinetic and Preliminary Efficacy of Q702 in Subjects With Relapsed or Refractory Active Chronic Graft-versus-Host Disease (cGVHD)
NCT07138196
Principal SponsorQurient Co., Ltd.
Study ContactQurient Clinical Trial Information
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchiolitis Obliterans SyndromeOrganizing PneumoniaBronchial DiseasesBronchiolitisBronchiolitis ObliteransBronchitisGraft vs Host DiseaseImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory Tract Diseases

Criteria

5 inclusion criteria required to participate
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.
Show More Criteria
5 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Escalating doses of adrixetinib in 28 day cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Recruiting

Hospital Clinic de Barcelona

Barcelona, SpainOpen Hospital Clinic de Barcelona in Google Maps
Recruiting

Hospital General Universitario Gregorio Maranon

Madrid, Spain
Recruiting

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain
Recruiting

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain
Recruiting
8 Study Centers
Adrixetinib for Relapsed or Refractory cGVHD | PatLynk