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

NCT04883918 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ASC-aGVHD-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute-graft-versus-host Disease

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR) at Day 28

  28 days post-infusion

• Number of adverse events, and serious AEs

  30 days post-infusion

Secondary Outcomes (3)

• 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

Study Arms (1)

ASC930

EXPERIMENTAL

Experimental Arm

Biological: ASC930

Interventions

ASC930 BIOLOGICAL

4 intravenous doses of ASC930

ASC930

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ASC Therapeutics: lead

Central Study Contacts

Clinical Trial Manager, PhD

CONTACT

(408) 495-3891; gil.gonen@asctherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: December 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share