A 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)
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).
• 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.