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Not yet recruitingNCT04883918Updated Jul 20, 2023

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

A Phase 2 interventional study of ASC930 in Acute-graft-versus-host Disease, sponsored by ASC Therapeutics. Not yet recruiting. Open to participants aged 2 Months and older. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by ASC Therapeutics · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
2 Months and older
Sex
All
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Study 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.

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Conditions studied

  • Acute-graft-versus-host Disease

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In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's planned enrollment of 60 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

ASC Therapeutics is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    ASC930

    Experimental Arm

    Biological: ASC930

Interventions

  • BiologicalASC930

    4 intravenous doses of ASC930

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What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR) at Day 28

    Time frame: 28 days post-infusion

  2. Number of adverse events, and serious AEs

    Time frame: 30 days post-infusion

Secondary outcomes

  1. Duration of response (DOR) at DAY 180

    Time frame: 180 days post-infusion

  2. Overall survival (OS) rate at DAY 180

    Time frame: 180 days post-infusion

  3. Complete Response (CR) at Day 28 and Day 180

    Time frame: 28 and 180 days post-infusion

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04883918
Lead sponsor
ASC Therapeutics
Responsible party
Sponsor
First posted
May 12, 2021
Start date
Dec 2023 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Jul 20, 2023

Study contacts

Clinical Trial Manager, PhD
Contact
gil.gonen@asctherapeutics.com
(408) 495-3891

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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