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

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ClinicalTrials.gov Identifier: NCT04014790
Recruitment Status : Completed
First Posted : July 10, 2019
Results First Posted : April 17, 2024
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Regimmune Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Graft Vs Host Disease Graft-versus-host-disease Acute-graft-versus-host Disease Prevention of aGVHD Drug: RGI-2001 Drug: Standard of Care Phase 2

Detailed Description:
This is an open-label, multi-center, single-arm study to evaluate six weekly doses of RGI-2001 in combination with standard of care treatment for the prevention of aGvHD in subjects following alloHSCT. The study will include a Safety Run-in Phase to assess the safety and tolerability of 6 weekly doses of RGI-2001 followed by an Expansion Phase in which the potential efficacy of 6 weekly doses of RGI-2001 in addition to standard of care for GvHD prophylaxis will be assessed. Comparison will be made to a contemporaneous control group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 25, 2019
Actual Primary Completion Date : July 5, 2022
Actual Study Completion Date : April 3, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RGI-2001
Subjects will be administered RGI 2001 in combination with standard of care treatment
 Drug: RGI-2001
Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
Other Names:
  • KRN-7000
  • RGI-7000

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


Outcome Measures
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Primary Outcome Measures :
  1. Grades II-IV aGVHD [ Time Frame: Day 100 post-transplant ]
    Acute GVHD will be graded and assessed according to modified KEYSTONE criteria and the severity grade (Grade II through IV) were captured up through the first 100 days post-transplant


Secondary Outcome Measures :
  1. Grades II-IV aGVHD [ Time Frame: Day 180 post-transplant ]
    Acute GVHD will be graded and assessed within 180 days post-transplant

  2. Non-relapse Mortality (NRM) Rates [ Time Frame: 1 year post-transplant ]
    The probability of mortality not preceded by relapse of the underlying malignancy will be estimated

  3. Disease-free Survival (DFS) [ Time Frame: 1 year post-transplant ]
    The probability of survival without relapse of the underlying malignancy will be estimated

  4. GvHD-free, Relapse Free Survival (GRFS) [ Time Frame: 1 year post-transplant ]
    The probability of survival without relapse of the underlying malignancy, without severe (grades 3-4) acute GVHD, and without chronic GVHD requiring systemic immunosuppression will be estimated

  5. Overall Survival (OS) [ Time Frame: 1 year post-transplant ]
    The probability of survival will be estimated


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages ≥ 18 and ≤ 65 years of age
  2. Has a hematologic malignancy which includes 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
  3. Must have adequate organ function
  4. Transplant Donor: Matched related donor or Unrelated donor
  5. Is a candidate for anti-graft-vs-host-disease (GvHD) prophylaxis that includes a calcineurin inhibitor
  6. Ability to understand and willingness to sign a written informed consent form
  7. If female of childbearing potential, must have had a negative serum pregnancy test prior to enrollment and must have agreed to use a double barrier method of contraception for 30 days after RGI-2001 administration
  8. If male, must be sterile or willing to use an approved method of contraception from the time of informed consent to 90 days after last dose of RGI-2001 administration

Exclusion Criteria:

  1. Has had any other prior organ transplantation
  2. Planned procedure to deplete regulatory T cells from donor transplant materials
  3. Planned reduced intensity conditioning
  4. Has had prior treatment with anti-CD3, other T cell depleting antibodies, or anti-thymocyte globulin within 12 months prior to alloHSCT procedure
  5. Has progressive underlying malignant disease including post-transplant lymphoproliferative disease
  6. Has evidence of active central nervous system (CNS) disease including known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of CNS involvement)
  7. Is female and pregnant or lactating
  8. Has a documented history of uncontrolled autoimmune disease or on active treatment
  9. History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to receiving study drug
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014790


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Florida
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10087-6453
United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Regimmune Corporation
Investigators
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Principal Investigator: Yi-Bin Chen, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Regimmune Corporation:
Study Protocol  [PDF] March 6, 2020
Statistical Analysis Plan  [PDF] July 14, 2023

More Information
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Responsible Party: Regimmune Corporation
ClinicalTrials.gov Identifier: NCT04014790    
Other Study ID Numbers: RGI-2001-003
First Posted: July 10, 2019    Key Record Dates
Results First Posted: April 17, 2024
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
KRN 7000
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents