Adrixetinib (Q702) for adults with active chronic graft-versus-host disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label Phase 1, dose-escalation study testing Adrixetinib (Q702) in adults with relapsed or refractory active chronic graft-versus-host disease after allogeneic HSCT. The study will primarily measure safety, tolerability, and pharmacokinetics/pharmacodynamics across escalating dose cohorts and will also record preliminary signals of efficacy. Eligible participants must have moderate or severe active cGVHD requiring systemic immunosuppression and adequate organ and marrow function. Treatment and follow-up visits will take place at designated hospital sites in Spain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects who are allogeneic HSCT recipients with moderate or severe active cGVHD requiring systemic immune suppression.
2. Subjects with relapsed or refractory active cGVHD who have progressed after all available standard of care treatments.
3. 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.
4. Adequate organ and bone marrow functions.
5. Karnofsky Performance Scale of ≥ 60.

Exclusion Criteria:

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

Where it's running

• Hospital Clinic de Barcelona
  Barcelona, Spain 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
• Clinica Universidad de Navarra
  Pamplona, Spain Recruiting
• Hospital Universitario Marques de Valdecilla
  Santander, Spain Recruiting

Study contacts

• Study coordinator: Qurient Clinical Trial Information
• Email: clinicaltrial_info@qurient.com
• Phone: +82-31-8060-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.