Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction. Despite pivotal advances, aGVHD is one of the leading causes of non-relapse mortality in patients undergoing HCT. Placenta-derived DSCs, isolated from the fetal membrane of maternal origin, are a type of stromal cells with well-characterized immunosuppressive properties. The current study is designed to assess the safety and efficacy of 4 intravenous (IV) doses of ASC930 DSC cells in aGVHD patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
4 intravenous doses of ASC930
Overall Response Rate (ORR) at Day 28
Time frame: 28 days post-infusion
Number of adverse events, and serious AEs
Time frame: 30 days post-infusion
Duration of response (DOR) at DAY 180
Time frame: 180 days post-infusion
Overall survival (OS) rate at DAY 180
Time frame: 180 days post-infusion
Complete Response (CR) at Day 28 and Day 180
Time frame: 28 and 180 days post-infusion
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