← Back to Search

Immunomodulator

RGI-2001 for Graft-versus-Host Disease

Phase 2
Waitlist Available
Led By Yi-Bin Chen, MD
Research Sponsored by Regimmune Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if RGI-2001, given regularly along with standard care, can prevent a serious complication in patients who have had a stem cell transplant.

Eligible Conditions
  • Graft-versus-Host Disease
  • Prevention of Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grades II-IV aGVHD
Secondary study objectives
Disease-free Survival (DFS)
GvHD-free, Relapse Free Survival (GRFS)
Non-relapse Mortality (NRM) Rates
+1 more

Side effects data

From 2023 Phase 2 trial • 49 Patients • NCT04014790
22%
Nausea
20%
Rash
18%
Stomatitis
18%
Diarrhea
18%
Vomiting
18%
Decreased Appetite
14%
Fatigue
14%
Abdominal Pain
14%
Platelet Count Decreased
12%
Muscosal Inflammation
12%
Anaemia
12%
Dyspnoea
12%
Alanine Aminotransferase increased
12%
Neutrophil Count Decreased
12%
Hypomagnesaemia
12%
White blood cell count decreased
10%
Dysgeusia
8%
Hyponatremia
8%
Headache
8%
Dry Skin
8%
Hyperglycemia
8%
Dizziness
8%
Pruritis
6%
Constipation
6%
Hyperphosphataemia
6%
Aspartate Aminotransferase increased
6%
Blood Alkaline Phosphatase Increased
6%
Hypophosphataemia
6%
Blood Lactate Dehyrogenase increased
6%
Blood Creatinine increased
6%
Tremor
6%
Hypertension
2%
Myocarditis
2%
Septic Shock
2%
Upper respiratory infection
2%
Pelvic Pain
2%
Deep Vein Thrombosis
2%
Pulmonary veno-occlusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
RGI-2001

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RGI-2001Experimental Treatment2 Interventions
Subjects will be administered RGI 2001 in combination with standard of care treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGI-2001
2019
Completed Phase 2
~120
Standard of Care
2017
Completed Phase 4
~4420

Find a Location

Who is running the clinical trial?

Regimmune CorporationLead Sponsor
2 Previous Clinical Trials
93 Total Patients Enrolled
Yi-Bin Chen, MDPrincipal InvestigatorMassachusetts General Hospital
7 Previous Clinical Trials
145 Total Patients Enrolled
~8 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top