Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

Inclusion Criteria

• Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations
• European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, [CRi] is also allowable
• Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft
• Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
• Planned use of TAC-based GvHD prophylaxis
• age ≥ 18 years and ≤ 75 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

• Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis

• Diagnosis of macular edema during screening

• Cardiac/pulmonary/hepatic/renal dysfunction

• Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); or total bilirubin > 1.5 mg/dL

• Renal dysfunction with estimated creatinine clearance < 45 mL/min by the Cockcroft-Gault formula

  • Diabetes mellitus
  • History or presence of uveitis at screening
  • History or diagnosis of macular edema