At a glance
ClinicalIndex Comparison Record- ✓Age ≥2 years at informed consent
- ✓Allogeneic HSCT recipients with active cGVHD requiring systemic immune suppression per 2014 NIH criteria
- ✓Refractory or recurrent active cGVHD despite ≥2 prior lines of systemic therapy
- ✓Adequate organ and bone marrow functions within 14 days of randomization
- ✕Acute GVHD without cGVHD manifestations
- ✕Evidence of relapse of underlying cancer or post-transplant lymphoproliferative disease at screening
- ✕History of acute or chronic pancreatitis
- ✕History of myositis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04710576Phase 2RecruitingUpdate OverdueCompletion was 38mo agoAGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy
In Brief
A Phase 2 clinical trial evaluating Axatilimab for Chronic Graft-versus-host-disease. Currently recruiting, targeting 296 participants across 121 sites in 16 countries.
Signals
Detailed Summary
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.
Study Details
Timeline
Interventions
Axatilimab is a high-affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be the key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGVHD.