AGAVE-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.

Chronic graft versus host disease (cGVHD)

1. ORR in the first 6 cycles as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in cGVHD

1. mLSS, 2. - ORR, - DOR, - SRR, - Organ-specific and joints and fascia response rate, - Average daily corticosteroid dose, - Discontinue corticosteroid, - Average daily CNI dose, - Discontinue CNI., 3. - AEs and SAEs, - Vital signs, safety laboratory parameters, physical/neurological examination, ECG, and Karnofsky/Lansky performance scale., 4. PK parameters and patient factors., 5. CSF-1, IL-34 levels., 6. Circulating monocyte number and phenotype., 7. Baseline circulating monocyte number and phenotype.

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