Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

RecruitingPhase 1/2

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

Subjects with suboptimal response to ruxolitinib:

* Treatment with at a stable dose of ruxolitinib prior to study entry
* Subjects ≥ 18 years of age and able to provide informed consent.
* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
* High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)
* Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate hematological, hepatic, \& renal function.

Exclusion Criteria:

Treatment-naive subjects:

* Prior treatment with any JAKi

Subjects with suboptimal response to ruxolitinib:

* Documented disease progression while on ruxolitinib treatment

All subjects:

* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
* Prior treatment with a BTK or BMX inhibitor

About the study

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

What is being tested

TL-895 (drug)
Ruxolitinib (drug)

Sponsor: Telios Pharma, Inc. · Participants: 70 · Started: Jun 9, 2022

Contact the study team

John Mei · Phone: 650-542-0136

Official record on ClinicalTrials.gov — NCT05280509

Locations in the U.S.

Alabama	University of Alabama at Birmingham, Birmingham
Ohio	Gabrail Cancer Center, Canton University of Cincinnati (UC), Cincinnati
Texas	The University of Texas MD Anderson Cancer Center, Houston

Conditions

Myelofibrosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.