Acute-graft-versus-host DiseasePhase 2NCT04883918
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
A Phase 2 study testing ASC930 in people with Acute-graft-versus-host Disease, run by ASC Therapeutics.
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. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Acute-graft-versus-host Disease
- What is being tested?
- ASC930
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease
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
- Being tested
- ASC930
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC930Biological
4 intravenous doses of ASC930
| Study group | Role | What they receive |
|---|---|---|
| ASC930 | Experimental | Experimental Arm Receives: Biological: ASC930 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) at Day 28
Measured: 28 days post-infusion
Number of adverse events, and serious AEs
Measured: 30 days post-infusion
Secondary outcomes (3)
Duration of response (DOR) at DAY 180
Measured: 180 days post-infusion
Overall survival (OS) rate at DAY 180
Measured: 180 days post-infusion
Complete Response (CR) at Day 28 and Day 180
Measured: 28 and 180 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study startDec 2023 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASC Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883918
- Sponsor's protocol ID
- ASC-aGVHD-001
- Status last verified
- Jan 2023
- First submitted
- 7 May 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT04883918
- Acronym / sponsor ID
- ASC-aGVHD-001
- Conditions
- Acute-graft-versus-host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ASC TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASC930 | Experimental | Biological: ASC930Experimental Arm |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Karnofsky/Lansky Performance Status of at least 30 at the time of study entry
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC9304 intravenous doses of ASC930 | Biological | ASC930 |
Primary outcome
Overall Response Rate (ORR) at Day 28
Time frame: 28 days post-infusion
Number of adverse events, and serious AEs
Time frame: 30 days post-infusion
3 secondary outcomes
Duration of response (DOR) at DAY 180
Time frame: 180 days post-infusion
Overall survival (OS) rate at DAY 180
Time frame: 180 days post-infusion
Complete Response (CR) at Day 28 and Day 180
Time frame: 28 and 180 days post-infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC930 in people with Acute-graft-versus-host Disease, run by ASC Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager, PhD ((408) 495-3891, gil.gonen@asctherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) at Day 28 (time frame: 28 days post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.