A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

Inclusion Criteria

• •1. Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent Document).
• •2. Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted.
• •3. Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory (R/R) higher-risk MDS (Myelodysplastic Syndrome) (HR-MDS) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies.
• •1. In Part A, R/R AML
• •2. In Part B, R/R AML including
• •* Relapsed after allogeneic HSCT or
• •* In second or later relapse or
• •* Refractory to initial induction or re-induction treatment or
• •* Refractory or relapse after HMA treatment (HMA failure defined as primary progression or lack of clinical benefit after a minimum of 6 cycles or unable to tolerate HMA due to toxicity) or
• •* Refractory within 1 year of initial treatment (excluding those with favorable risk based on cytogenetics)
• •3. In Part B, R/R HR-MDS (Revised International Prognostic Scoring System score (IPSS-R) \> 3.5 points, IPSS-R calculated during screening period):
• •* IPSS-R intermediate risk (in combination with more than 10% bone marrow blasts or poor or very poor IPSS-R cytogenetic risk) or
• •* IPSS-R high or
• •* IPSS-R very high risk
• •4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
• •5. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI) without conditioning.
• •6. Subjects must have the following screening laboratory values:
• •* Corrected serum Ca or free (ionized) serum Ca within normal limits (WNL).
• •o Corrected Ca (mg/dL) = Total Ca (mg/dL) - 0.8 (albumin \[g/dL\] - 4)
• •* Total White Blood Cell count (WBC) \< 25 x 10\^9/L prior to first infusion. Prior or concurrent treatment with hydroxyurea to achieve this level is allowed.
• •* Potassium and magnesium within normal limits or correctable with supplements.
• •* Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamate pyruvic transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN).
• •* Uric acid ≤ 7.5 mg/dL (446 μmol/L). Prior and/or concurrent treatment with hypouricemic agents (eg, allopurinol, rasburicase) are allowed.
• •* Selected electrolytes within normal limits or correctable with supplements.
• •* Serum bilirubin ≤ 1.5 x ULN (upper limit of normal).
• •* Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated.
• •* International normalized ratio (INR) \< 1.5 x ULN and Partial thromboplastin time (PTT) \< 1.5 x ULN.