CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
RGI-2001 +1 moredrug
Likely dose
RGI-2001 100 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04014790
NCT04014790Phase 2Completed
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An Open Label Phase 2, Study to Evaluate the Safety and Efficacy of RGI-2001 for the Prevention of Acute Graft-vs-Host Disease Compared to Contemporary Controls in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

Regimmune Corporation·interventional·Posted Jul 10, 2019·Updated May 28, 2024

In Brief

A Phase 2 clinical trial evaluating RGI-2001 and Standard of Care for Graft Vs Host Disease and 3 related conditions. Completed, enrolled 49 participants across 7 sites.

Detailed Summary

This Phase II open label study will evaluate the safety and efficacy of repeat doses of RGI-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). These subjects will be compared to contemporary controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Vs Host Disease, Graft-versus-host-disease, Acute-graft-versus-host Disease, Prevention of aGVHD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 10, 2019
Enrollment StartNov 25, 2019
Primary CompletionJul 5, 2022
Study CompletionApr 3, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.0 years ago

Interventions

RGI-2001drug

Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT

Standard of Caredrug

Standard of care prophylaxis regimen will be administered according to institutional guidelines