This study will be conducted to evaluate the safety, efficacy, and pharmacokinetics of axatilimab monotherapy in Chinese participants with recurrent or refractory active chronic graft-versus-host disease after systemic therapy.
At least 12 years of age at the time of signing the ICF.
Ability to comprehend and willingness to sign a written ICF for the study.
Chinese participants who are allo-HSCT recipients with active, refractory, or recurrent cGVHD requiring systemic immune suppression despite prior systemic therapy, including corticosteroids and at least 1 other appropriate treatment for refractory or recurrent cGVHD.
Active cGVHD is defined as the presence of signs and symptoms of cGVHD per the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (Jagasia et al 2015).
Has aGVHD without manifestations of cGVHD.
Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
History of acute or chronic pancreatitis.
Active symptomatic myositis.
Parallel
INCA034176
DrugIV infusion
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event, occurring after the first dose.
Objective Response in the First 6 Cycles
The overall response rate will be assessed by the number of participants with objective response by Cycle 7 (28-day cycles), Day 1, with responses defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score
Overall Response Rate
Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
Duration of Response
Defined as the time from initial response of partial response or complete response until documented progression of cGVHD, start of new therapy, or death due to any cause, whichever occurs first.
Organ-specific Response Rate
Organ-specific response is defined as the number of participants with objective response for the nine individual organs based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (skin, eyes, mouth, esophagus, upper gastrointestinal \[GI\], lower GI, liver, lungs and joints and fascia).
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