Acute Myeloid Leukemia Clinical Trial
Official title:
Clinical Study of Conjugated Antibody Redirecting Natural Killer (CAR-NK) Cells Targeting CD33 and CLL1 in Patients With Acute Myeloid Leukemia
This is an open-label, nonrandomized, investigator-initiated clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of anti-CD33/CLL1 CAR-NK cell injection in patients with acute myeloid leukemia (AML), and to determine PK parameters, maximum tolerated dose (MTD), and phase II recommended dose (RP2D) for subjects receiving CAR-NK cell injection.
The treatment cycle in this study is 28 days. The administration of CAR-NK cells will be performed on day 1 and day 3 of each cycle. Subjects will be treated continuously until the criteria for termination of treatment are met. In this study, the dose escalation design is adopted. The first administration dose in the first cycle is 2.0×10^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 3.0×10^9 cells, and each administration dose in the second cycle and thereafter would be 3.0×10^9 cells. ;
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