A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

  • End date
    Dec 1, 2025
  • participants needed
  • sponsor
    Telios Pharma, Inc.
Updated on 25 October 2022


This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

Condition Myelofibrosis
Treatment TL-895
Clinical Study IdentifierNCT04655118
SponsorTelios Pharma, Inc.
Last Modified on25 October 2022


Yes No Not Sure

Inclusion Criteria

Adults ≥18 years of age
Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
Palpable spleen measuring ≥5 cm below the LLCM or spleen volume of ≥450 cm³ by MRI or CT scan assessment
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Adequate hematologic, hepatic, and renal functions

Exclusion Criteria

Prior treatment with any BTK or BMX inhibitors
Cohorts 1 and 2 - Prior treatment with JAKi within 21 days of the Screening MRI/CT scan. Subjects in Cohort 3 must not have received JAKi
Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
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