A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)

Last updated: December 12, 2025
Sponsor: Deciphera Pharmaceuticals, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Primary Biliary Cholangitis

Treatment

Vimseltinib

Clinical Study ID

NCT06619561
DCC-3014-02-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients withmoderate to severe cGVHD requiring systemic immune suppression. a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD)manifestations (overlap syndrome).

  2. Participants with active cGVHD who have received and failed at least 2 prior linesof systemic therapy.

  3. Stable dose of systemic corticosteroids is permitted but not required. If beingtaken, participants should be on a stable dose of corticosteroids for at least 2weeks prior to starting study drug treatment.

  4. Adequate organ and bone marrow functions.

  5. Participants of reproductive potential agree to follow the contraceptionrequirements.

  6. Karnofsky Performance Scale (KPS) of ≥60.

Exclusion

Exclusion Criteria:

  1. Has aGVHD without manifestations of cGVHD.

  2. Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.

  3. History or other evidence of severe illness, uncontrolled infection, or any otherconditions that would make the participant unsuitable for the study. All wounds mustbe healed and free of infection or dehiscence.

  4. History of malignancy except for:

  5. Underlying malignancy for which the transplant was performed

  6. Malignancy treated with curative intent and with no evidence of active diseasepresent for more than 3 years prior to enrollment and felt to be at low riskfor recurrence.

  7. Malabsorption syndrome or other illness that could affect oral absorption.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Vimseltinib
Phase: 2
Study Start date:
November 21, 2024
Estimated Completion Date:
October 31, 2029

Connect with a study center

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Ronald Regan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Ronald Regan UCLA Medical Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • University of California Irvine Health

    Orange 5379513, California 5332921 92868-3201
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando 4167147, Florida 4155751 32804
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Emory University Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University Winship Cancer Institute

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • University of Illinois Medical Center - Hematology & Oncology

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • University of Kansas Cancer Center-Westwood

    Westwood, Kansas 66205
    United States

    Site Not Available

  • University of Kansas Cancer Center-Westwood

    Westwood 4281639, Kansas 4273857 66205
    United States

    Active - Recruiting

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Markey Cancer Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Henry Ford Cancer Institute

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Cancer Institute

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis 4407066, Missouri 4398678 63108
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • Duke University Hospital

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati 4508722, Ohio 5165418 45242
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls 5231851, South Dakota 5769223 57105
    United States

    Active - Recruiting

  • Tristar Bone Marrow Transplant

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tristar Bone Marrow Transplant

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • St. David's South Austin Medical Center

    Austin, Texas 78704
    United States

    Site Not Available

  • St. David's South Austin Medical Center

    Austin 4671654, Texas 4736286 78704
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • Intermountain Health

    Salt Lake City 5780993, Utah 5549030 84143
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond 4781708, Virginia 6254928 23298
    United States

    Active - Recruiting

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