A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

Exclusion Criteria

• •1. Diagnosis of acute promyelocytic leukemia.
• •2. Isolated extramedullary relapse (phase 2 only).
• •3. Active central nervous system (CNS) leukemia.
• •4. History of other malignancy.
• •5. Any of the following cardiopulmonary abnormalities:
• •1. Myocardial infarction within six months prior to registration.
• •2. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \< 50%.
• •3. A history of familial long QT syndrome.
• •4. Symptomatic atrial or ventricular arrhythmias not controlled by medications.
• •5. QTcF ≥ 470 msec calculated according to institutional guidelines, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor.
• •6. Known moderate to severe and clinically significant chronic obstructive pulmonary disease, interstitial lung disease and/or pulmonary fibrosis (e.g., requiring home oxygen therapy).
• •6. Pregnancy and/or lactation.
• •7. Major surgery (excluding placement of vascular access) within 4 weeks prior to first dose of CTX-712.
• •8. History of allogeneic organ transplantation (excluding cornea).
• •9. History of allogenic hematopoietic stem cell transplantation within 6 months of planned study treatment initiation and/or graft-versus host disease grade ≥ 1 following allogenic hematopoietic stem cell transplantation.
• •10. History of or chimeric antigen receptor T-cell therapy or other modified T cell therapy.
• •11. Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus, or acquired immunodeficiency syndrome related illness. Infections controlled with oral anti-infective agents, including prophylactic treatments, are allowed. Patient must be viral load negative.
• •12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.