Tagraxofusp (SL-401) in Patients With CMML or MF

This is a non-randomized, open-label, multicenter study, divided into multiple stages. Patients with chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF) will be treated with tagraxofusp (SL-401), which will be administered as a brief intravenous infusion for 3 consecutive days every 21 days during Cycles 1-4; and every 28 days during Cycle 5 and beyond. Stage 1 consisted of a period in which several doses of SL-401 were evaluated; Stage 1 is now closed. The Stage 2 portion will enroll up to 30 patients with CMML and up to 50-55 patients with MF, who will be treated at the maximum tested dose in which multiple dose-limiting toxicities were not observed (identified in Stage 1). Stage 3A will enroll 2 populations of patients with CMML, those with CMML-1 or CMML-2 who are refractory/resistant/intolerant to HMAs, or HU, or intensive chemotherapy; and treatment-naive patients with CMML-1 or CMML-2 with molecular features associated with a poor prognosis (up to 20 patients each).

Tagraxofusp (SL-401) in Patients with Chronic Myelomonocytic Leukemia (CMML) or Myelofibrosis (MF)