← 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

Study Summary

This trial will study whether repeat doses of RGI-2001 can help prevent aGvHD in people who have recently undergone alloHSCT.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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%
Diarrhea
18%
Stomatitis
18%
Vomiting
18%
Decreased Appetite
14%
Abdominal Pain
14%
Fatigue
14%
Platelet Count Decreased
12%
Anaemia
12%
Muscosal Inflammation
12%
Alanine Aminotransferase increased
12%
Neutrophil Count Decreased
12%
White blood cell count decreased
12%
Hypomagnesaemia
12%
Dyspnoea
10%
Dysgeusia
8%
Hyperglycemia
8%
Hyponatremia
8%
Headache
8%
Dry Skin
8%
Pruritis
8%
Dizziness
6%
Constipation
6%
Aspartate Aminotransferase increased
6%
Blood Alkaline Phosphatase Increased
6%
Blood Creatinine increased
6%
Blood Lactate Dehyrogenase increased
6%
Hyperphosphataemia
6%
Hypophosphataemia
6%
Tremor
6%
Hypertension
2%
Myocarditis
2%
Septic Shock
2%
Pelvic Pain
2%
Pulmonary veno-occlusive disease
2%
Deep Vein Thrombosis
2%
Upper respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
RGI-2001

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are enrolled in this research project?

"Unfortunately, this study has completed recruitment as of October 24th, 2022. It was originally posted on November 25th, 2019. However, there are 170 other trials that may be of interest and are actively recruiting patients right now."

Answered by AI

Could you tell me if people who are not yet 30 years old can join this clinical trial?

"The age range for eligible patients in this clinical trial is 18 to 64 years old. There are 65 different trials available for minors and 147 options for senior citizens."

Answered by AI

Is this a novel clinical trial?

"RGI-2001 has an extensive history, with the first study being performed in 2019. This initial research was sponsored by Regimmune Corporation and only involved 49 people. Despite its limited sample size, RGI-2001 received Phase 2 drug approval after this first trial. Presently, there are 2 active studies involving RGI-2001 located in 8 cities across 1 country."

Answered by AI

Are there any patients still needed for this clinical trial?

"The clinicaltrial.gov website reveals that this study is not currently looking for patients, although it was accepting them in the past. This trial was first posted on November 25th, 2019 and updated October 24th, 2022. There are 172 other trials recruiting patients at this moment."

Answered by AI

In how many different medical institutions is this research being conducted?

"There are 7 sites currently active for this trial, they are: Columbia University Irving Medical Center in New york, University of Miami, Sylvester Comprehensive Cancer Center in Miami, and University of Maryland Greenebaum Comprehensive Cancer Center in Baltimore. Plus 4 other centres."

Answered by AI

What is the scientific community's previous experience with RGI-2001?

"The drug RGI-2001 was first studied in 2019 at Washington University Siteman Cancer Center. By now, there have been 230 completed trials and 2 more are recruiting patients. Most of these New york based trials."

Answered by AI

What is the mortality rate of RGI-2001?

"The safety of RGI-2001 was evaluated to be a 2. Phase 2 trials have less clinical data supporting both efficacy and safety in comparison to other stages of testing."

Answered by AI

Who would be a good candidate for enrolling in this experiment?

"The aim of this study is to treat 49 patients suffering from hematologic malignancies that are between 18 and 64 years old. To be eligible, potential participants must also have adequate organ function and meet one of the following criteria: Acute myelogenous leukemia (AML), T or B cell acute lymphoblastic leukemia (ALL) Myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), myeloproliferative disorder (MPD) including myeloid metaplasia and CML."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation
2019. "RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04014790.
~9 spots leftby Apr 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