A Phase 1b/2 Study of the Safety, PK, PD and Preliminary Efficacy of the FLT3 Inhibitor Gilteritinib, in Combination with the Selective SYK Inhibitor Lanraplenib (KB-9876), in Patients with FLT3-mutated Relapsed or Refractory AML

Protocol No
KRONOS-KB-LANRA-1001
Principal Investigator
Laura Michaelis
Phase
I/II
Summary
This multicenter, Phase 1b/2 study will investigate the safety, PK, PD and make a preliminary assessment of the anti-leukemic activity of the selective, 3rd generation SYK inhibitor, LANRA, in combination with the selective FLT3 inhibitor, gilteritinib, in patients with FLT3-mutated AML, who have recurrence of leukemia or are refractory after at least 1 prior regimen. This study will be conducted in 2 parts: dose escalation (Phase 1b) and cohort expansion (Phase 2).
Description
To evaluate the safety of LANRA in combination with the FLT3 inhibitor gilteritinib, in patients with R/R FLT3-mutated AML.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL