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

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

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