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Evaluating Vimseltinib for Chronic Graft-Versus-Host Disease in Adults

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, PK, and Efficacy of Vimseltinib in Adults With Active Chronic GVHD After Failure of Prior Systemic Therapy

Phase 2 Interventional Deciphera Pharmaceuticals, LLC · NCT06619561

This study is testing if a new medication called vimseltinib can help adults with tough cases of chronic graft-versus-host disease feel better after other treatments haven't worked.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment48 (estimated)
Ages18 Years and up
SexAll
SponsorDeciphera Pharmaceuticals, LLC Industry-sponsored
Drugs / interventionsvimseltinib
Locations26 sites (Duarte, California and 25 other locations)
Trial IDNCT06619561 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and effectiveness of vimseltinib in treating adults with active moderate to severe chronic graft-versus-host disease (cGVHD). Participants will receive vimseltinib in 28-day treatment cycles over a period of approximately two years. The study focuses on individuals who have previously undergone allogeneic hematopoietic stem cell transplantation and have not responded to at least two prior systemic therapies. The goal is to improve treatment outcomes for patients suffering from this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults who are allogeneic hematopoietic stem cell transplant recipients with moderate to severe cGVHD requiring systemic immune suppression.

Not a fit: Patients with acute graft-versus-host disease without chronic manifestations or those who have previously used a CSF1R inhibitor for cGVHD may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chronic graft-versus-host disease who have limited treatment alternatives.

How similar studies have performed: While the specific use of vimseltinib for cGVHD is novel, other studies have explored treatments for this condition, indicating a growing interest in finding effective therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Duarte, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Graft-Versus-Host DiseaseAllogeneic hematopoietic stem cell transplantGraft-Versus-Host DiseaseGVHDcGVHDGraft versus host diseaseImmune System DiseasesOrganizing Pneumonia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.