Clinical Trial 23641

• Overview

  Study Title:

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

  Objective:

  Primary: 1.To assess the safety and tolerability of vimseltinib in participants with cGVHD. 2. To determine the recommended dose(s) of vimseltinib for further development in participants with cGVHD. Secondary: 1. To evaluate efficacy and durability of response of vimseltinib in participants with cGVHD. 2. To assess the plasma PK of vimseltinib in participants with cGVHD.

• Treatments

  Therapies:

  Tyrosine Kinase Inhibitor

  Medications:

  Vimseltinib ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression. Note: May have persistent active GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).
  • Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
  • 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.
  • Adequate organ and bone marrow functions.
  • Participants of reproductive potential agree to follow the contraception requirements.
  • Karnofsky Performance Scale (KPS) of ≥60.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Has aGVHD without manifestations of cGVHD.
  • Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
  • History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study.
  • History of malignancy except for: Underlying malignancy for which the transplant was performed or 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.
  • Malabsorption syndrome or other illness that could affect oral absorption.

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