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New drug vimseltinib aims to tame chronic GVHD in failed treatments

NCT ID NCT06619561

Disease control Sponsor: Deciphera Pharmaceuticals, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether the drug vimseltinib is safe and effective for adults with moderate to severe chronic graft-versus-host disease (cGVHD) who have not improved after at least two prior treatments. About 48 participants will take vimseltinib daily for up to two years. The goal is to see if the drug can control the disease and reduce symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vimseltinib (a drug taken by mouth)
What this could lead to
If successful, this could offer a new treatment option for people with chronic GVHD who have not responded to other therapies.
What could go wrong
This is an early-phase trial with only 48 participants, so results may not apply to everyone. The drug may cause side effects or fail to improve symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate 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 lines of systemic therapy. 3. Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment. 4. Adequate organ and bone marrow functions. 5. Participants of reproductive potential agree to follow the contraception requirements. 6. Karnofsky Performance Scale (KPS) of ≥60. 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 other conditions that would make the participant unsuitable for the study. All wounds must be healed and free of infection or dehiscence. 4. History of malignancy except for: 1. Underlying malignancy for which the transplant was performed 2. Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence. 5. Malabsorption syndrome or other illness that could affect oral absorption.

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Conditions

The condition(s) this trial relates to.

bronchial disorder bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome chronic graft versus host disease Fibrosis graft versus host disease immune system disorder liver disorder lung disorder obstructive lung disease Organizing Pneumonia respiratory system disorder Sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic graft-versus-host disease (CGVHD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32804, United States

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Emory University Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Henry Ford Cancer Institute

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Intermountain Health

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Oncology Hematology Care Clinical Trials, LLC

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ronald Regan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • St. David's South Austin Medical Center

    RECRUITING

    Austin, Texas, 78704, United States

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Tristar Bone Marrow Transplant

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of California Irvine Health

    RECRUITING

    Orange, California, 92868-3201, United States

  • University of Illinois Medical Center - Hematology & Oncology

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Kansas Cancer Center-Westwood

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Kentucky Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine - Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63108, United States

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