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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute-graft-versus-host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASC930

Experimental Arm

Group Type EXPERIMENTAL

ASC930

Intervention Type BIOLOGICAL

4 intravenous doses of ASC930

Interventions

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ASC930

4 intravenous doses of ASC930

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No