Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
Trial Parameters
Brief Summary
This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 target CAR iPSC NK cells in patients with relapsed/refractory AML
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years old. 2. Confirmed diagnosis of r/r AML 3. CLL1 expression is positive in AML blasts. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks. 5. Adequate organ and marrow function, as defined below: 1. Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL/min; 2. Total bilirubin (TBIL) ≤ 2 x the ULN; 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN; 4. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN 6. Females of childbearing potential must have a negative serum pregnancy test. 7. Donor specific antibody (DSA) is negative: MFI \<= 2000. 8. Provision of signed and dated informed consent form (ICF). Exclusion Criteria: 1. Allergic to drug used in this study. 2. Subjects received any antitumor therapy as follows, prior to first NK infusion: 1. Systemic steroid therapy within 3