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

Sponsor
ASC Therapeutics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04883918
Collaborator
(none)
60
Enrollment
1
Arm
14
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: ASC930
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASC930

Experimental Arm

Biological: ASC930
4 intravenous doses of ASC930

Outcome Measures

Primary Outcome Measures

  1. Overall Response Rate (ORR) at Day 28 [28 days post-infusion]

  2. Number of adverse events, and serious AEs [30 days post-infusion]

Secondary Outcome Measures

  1. Duration of response (DOR) at DAY 180 [180 days post-infusion]

  2. Overall survival (OS) rate at DAY 180 [180 days post-infusion]

  3. Complete Response (CR) at Day 28 and Day 180 [28 and 180 days post-infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • ASC Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ASC Therapeutics
ClinicalTrials.gov Identifier:
NCT04883918
Other Study ID Numbers:
  • ASC-aGVHD-001
First Posted:
May 12, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Graft vs Host Disease

Study Results

No Results Posted as of Nov 18, 2021