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

This is a multi-center, randomized, double-blinded, placebo controlled trial.

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