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出境医 / 临床实验 / RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

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

Study Description
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)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : May 2022
Arms and Interventions
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
Primary Outcome Measures :
  1. Grades II-IV aGVHD [ Time Frame: Day 100 post-transplant ]
    Acute GVHD will be graded and assessed within 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: Day 100, 6 months and 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: 6 months and 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: 6 months and 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: 6 months and 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

Contacts
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Contact: Laurie Mellott 949-428-6650 laurie.mellott@clindatrix.com

Locations
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United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
United States, Florida
University of Miami, Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
United States, Maryland
University of Maryland Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Regimmune Corporation
Investigators
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Principal Investigator: Yi-Bin Chen, MD Massachusetts General Hospital
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE November 25, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Grades II-IV aGVHD [ Time Frame: Day 100 post-transplant ]
Acute GVHD will be graded and assessed within the first 100 days post-transplant
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Grades II-IV aGVHD [ Time Frame: Day 180 post-transplant ]
    Acute GVHD will be graded and assessed within 180 days post-transplant
  • Non-relapse mortality (NRM) rates [ Time Frame: Day 100, 6 months and 1 year post-transplant ]
    The probability of mortality not preceded by relapse of the underlying malignancy will be estimated
  • Disease-free survival (DFS) [ Time Frame: 6 months and 1 year post-transplant ]
    The probability of survival without relapse of the underlying malignancy will be estimated
  • GvHD-free, relapse free survival (GRFS) [ Time Frame: 6 months and 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
  • Overall survival (OS) [ Time Frame: 6 months and 1 year post-transplant ]
    The probability of survival will be estimated
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Graft Vs Host Disease
  • Graft-versus-host-disease
  • Acute-graft-versus-host Disease
  • Prevention of aGVHD
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: RGI-2001
Subjects will be administered RGI 2001 in combination with standard of care treatment
Interventions:
  • Drug: RGI-2001
  • Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laurie Mellott 949-428-6650 laurie.mellott@clindatrix.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014790
Other Study ID Numbers  ICMJE RGI-2001-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Regimmune Corporation
Study Sponsor  ICMJE Regimmune Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yi-Bin Chen, MD Massachusetts General Hospital
PRS Account Regimmune Corporation
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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