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

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