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

Prior treatment

• Prior treatment with any JAKi
  • Subjects with suboptimal response to ruxolitinib:
• Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
• Prior treatment with a BTK or BMX inhibitor

Other illness

• Documented disease progression while on ruxolitinib treatment
  • All subjects:

Other

• Treatment-naive subjects:

• 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.