ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)

ASC Therapeutics

Status and phase

Not yet enrolling

Phase 2

Conditions

Acute-graft-versus-host Disease

Treatments

Biological: ASC930

Study type

Interventional

Funder types

Industry

Identifiers

NCT04883918

ASC-aGVHD-001

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

2+ months old

Volunteers

No Healthy Volunteers

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