A Phase I, Multicenter, Uncontrolled, Open-label, Non-randomized, Dose-Escalation Study of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
acute myeloid leukemia (N=72)
Treatment arms (4)
KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD)
Primary outcome measures
- Dose-limiting toxicity (part 1 only)
*Relapse defined as patients with any of the following relapse findings after achieving CR, CRh, or CRi: Myeloblasts >5%, and blood blasts in 2 peripheral blood samples at least 1 week apart.
✝Refractory defined as patients who have failed to achieve CR, CRh, or CRi after a sufficient duration of initial intensive chemotherapy or initial treatment with venetoclax or hypomethylating agents.
AML, acute myeloid leukemia; APML, acute promyelocytic leukemia; CR, complete response; CRh, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; CVD, cardiovascular disease; ECOG PS, Eastern Cooperative Oncology Group Performance Status; EFS, event-free survival; HBV; hepatitis B virus; HCV, hepatitis C virus, HIV, human immunodeficiency virus; HTLV1, human T-lymphotropic virus 1; MLFS, morphologic leukemia-free state; ORR, overall response rate; OS, overall survival; PR, partial response; SOC, standard of care; WBC, white blood cell.
Reference: ClinicalTrials.gov. 2845-001. Available at https://clinicaltrials.gov/study/NCT06812104. Accessed May 14, 2026.