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

Acute-graft-versus-host Disease Clinical Trial

Official title:

Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04883918
• Other study ID #: ASC-aGVHD-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: April 2026

Study information

• Verified date: January 2023
• Source: ASC Therapeutics
• Contact: Clinical Trial Manager, PhD
• Phone: (408) 495-3891
• Email: gil.gonen[@]asctherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Graft vs Host Disease

Intervention

Biological:
• ASC930
4 intravenous doses of ASC930

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ASC Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) at Day 28		28 days post-infusion
Primary	Number of adverse events, and serious AEs		30 days post-infusion
Secondary	Duration of response (DOR) at DAY 180		180 days post-infusion
Secondary	Overall survival (OS) rate at DAY 180		180 days post-infusion
Secondary	Complete Response (CR) at Day 28 and Day 180		28 and 180 days post-infusion