ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) (NCT04883918) | Clinical Trial Compass
UnknownPhase 2
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
60 participantsStarted 2023-12
Plain-language 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.
Who can participate
Age range
2 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.