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Immunomodulator

RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

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
  • GVHD
  • 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.
Secondary study objectives
Disease-free Survival (DFS)
Grades II-IV aGVHD
GvHD-free, Relapse Free Survival (GRFS)
+2 more

Side effects data

From 2023 Phase 2 trial • 49 Patients • NCT04014790
22%
Nausea
20%
Rash
18%
Decreased Appetite
18%
Stomatitis
18%
Diarrhea
18%
Vomiting
14%
Abdominal Pain
14%
Fatigue
14%
Platelet Count Decreased
12%
White blood cell count decreased
12%
Muscosal Inflammation
12%
Anaemia
12%
Dyspnoea
12%
Alanine Aminotransferase increased
12%
Neutrophil Count Decreased
12%
Hypomagnesaemia
10%
Dysgeusia
8%
Hyponatremia
8%
Headache
8%
Hyperglycemia
8%
Dry Skin
8%
Dizziness
8%
Pruritis
6%
Constipation
6%
Hyperphosphataemia
6%
Aspartate Aminotransferase increased
6%
Blood Alkaline Phosphatase Increased
6%
Blood Lactate Dehyrogenase increased
6%
Hypophosphataemia
6%
Blood Creatinine increased
6%
Tremor
6%
Hypertension
2%
Myocarditis
2%
Pelvic Pain
2%
Deep Vein Thrombosis
2%
Septic Shock
2%
Pulmonary veno-occlusive disease
2%
Upper respiratory infection
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 Dec 2025
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