Back to resultsASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
Primary Purpose
Acute-graft-versus-host Disease
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ASC930
Sponsored by
About this trial
This is an interventional treatment trial for Acute-graft-versus-host Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASC930
Arm Description
Experimental Arm
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR) at Day 28
Number of adverse events, and serious AEs
Secondary Outcome Measures
Duration of response (DOR) at DAY 180
Overall survival (OS) rate at DAY 180
Complete Response (CR) at Day 28 and Day 180
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04883918
Brief Title
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
Official Title
Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ASC Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-graft-versus-host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASC930
Arm Type
Experimental
Arm Description
Experimental Arm
Intervention Type
Biological
Intervention Name(s)
ASC930
Intervention Description
4 intravenous doses of ASC930
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) at Day 28
Time Frame
28 days post-infusion
Title
Number of adverse events, and serious AEs
Time Frame
30 days post-infusion
Secondary Outcome Measure Information:
Title
Duration of response (DOR) at DAY 180
Time Frame
180 days post-infusion
Title
Overall survival (OS) rate at DAY 180
Time Frame
180 days post-infusion
Title
Complete Response (CR) at Day 28 and Day 180
Time Frame
28 and 180 days post-infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Manager, PhD
Phone
(408) 495-3891
Email
gil.gonen@asctherapeutics.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
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