Study of REM-422 in Patients With AML or Higher Risk MDS

Exclusion Criteria25

• Active central nervous system (CNS) leukemia or a confirmed diagnosis of CNS leukemia.
• Has undergone hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of REM-422 or is receiving immunosuppressive therapy post HSCT at the time of screening, or has GVHD requiring systemic treatment (topical steroids for ongoing skin GVHD is permitted).
• Has immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
• Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.
• Clinically significant active infection. Note: Patients with simple urinary tract infection or uncomplicated bacterial pharyngitis responding to active treatment are permitted. Note: Patients receiving intravenous (IV) antibiotics ≤ 7 days prior to enrollment are excluded (prophylactic antibiotics, antivirals, or antifungals are permitted).
• Evidence of active HIV infection.
• Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Primary immunodeficiency.
• Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent.
• Note: Patients who are receiving topical or inhaled corticosteroids with minimal systemic absorption are eligible for enrollment and may continue with minimal corticosteroid use as long as they are on a stable dose.
• Live vaccine ≤ 6 weeks prior to the start of REM-422.
• Use of strong CYP3A inhibitors (except azole antifungals) or CYP3A inducers
• Drugs that reduce gastric acidity, such as H2-receptor antagonists (eg, ranitidine, famotidine) and proton pump inhibitors (eg, omeprazole, esomeprazole) within 7 days prior to the initiation of REM-422 administration or during the study.
• Currently pregnant, have intentions to become pregnant during the study duration, or are currently lactating.
• Has dysphagia, short-gut syndrome, gastroparesis, or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs.
• Current use of prohibited medication ≤ 1 week before starting REM-422.
• Clinically significant cardiovascular disease:
• Has undergone major surgery (opening a mesenchymal barrier such as the pleural cavity, peritoneum, or meninges or surgical procedures requiring general anesthesia) \< 4 weeks prior to enrollment.
• History of organ transplant that requires use of immunosuppressive agents.
• History or current autoimmune disease requiring systemic treatment (eg, Crohn's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus).
• Radiation therapy ≤ 7 days prior to the start of REM-422.
• Concurrent or previous other malignancy ≤ 2 years of enrollment, except curatively treated malignancies including basal or squamous cell skin cancer, breast cancer, prostate intraepithelial neoplasm, and carcinoma in situ of the cervix.
• Receiving any other investigational treatment for any indication ≤ 3 weeks prior to enrollment.
• Unwillingness or inability to follow protocol requirements.
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of REM-422 or interpretation of the participant's safety or study results.