Status:
NOT_YET_RECRUITING
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
Lead Sponsor:
ASC Therapeutics
Conditions:
Acute-graft-versus-host Disease
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04883918
Start Date
December 1 2023
End Date
April 1 2026
Last Update
July 20 2023
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