Acute-graft-versus-host Disease
Conditions
Brief summary
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.
Interventions
BIOLOGICALASC930
4 intravenous doses of ASC930
Sponsors
ASC Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants ≥ 2 months of age * Diagnosis of aGVHD grade II-IV following allogeneic HSCT according to standard criteria (Harris, 2016). * Diagnosis of SR-aGVHD according to Mohty (2020) * Meet one of the following criteria: * Participants who are Ruxolitinib-refractory, according to Mohty (2020) * Participants who are not eligible for SOC therapy * Participants who agree to receive ASC930 as a second-line therapy * Karnofsky/Lansky Performance Status of at least 30 at the time of study entry * Minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements).
Exclusion criteria
* Diagnosis of active Hepatic Sinusoidal Obstruction Syndrome (SOS) * Presence of an active uncontrolled infection * Active treatment for a hyprecoagulation disorder * Evidence of diffuse alveolar hemorrhage or other active pulmonary disease * Evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD * Evidence of relapse of malignancy * Receival of agents other than steroids for primary treatment of aGVHD * Severe allergic history to cell-based products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) at Day 28 | 28 days post-infusion |
| Number of adverse events, and serious AEs | 30 days post-infusion |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) at DAY 180 | 180 days post-infusion |
| Overall survival (OS) rate at DAY 180 | 180 days post-infusion |
| Complete Response (CR) at Day 28 and Day 180 | 28 and 180 days post-infusion |
Contacts
Primary ContactClinical Trial Manager, PhD
Outcome results
None listed