Phase 1 Study of CD123-CD16 Bispecific Antibody-Modified NK Cell Therapy for Adults With Relapsed or Refractory CD123-Positive Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the use of CD123-CD16 bispecific antibody-modified natural killer NK cells in patients with relapsed or refractory Acute Myeloid Leukemia RR AML that expresses CD123. This Phase 1 clinical trial aims to determine if these modified NK cells can induce remission and to assess the safety and potential side effects of this new immunotherapy approach. The study focuses on patients who have developed resistance to current treatments and have a limited survival prognosis. Participants will first receive lymphocyte-depleting chemotherapy with Fludarabine and Cyclophosphamide from day -5 to day -3 before NK cell infusion. After preconditioning, patients will receive intravenous infusions of donor-derived modified NK cells at escalating doses, starting with 1x107 cellskg, then 2x107 cellskg, and finally 4x107 cellskg. Infusions are given every 96 to 120 hours for a total of three infusions per dose group. Each infusion lasts 10 to 15 minutes. Dose escalation proceeds only after confirming the safety of the previous dose group. During the study, vital signs such as temperature, heart rate, respiratory rate, and blood pressure are closely monitored before and after each infusion. Baseline data are collected during infusions, and follow-up assessments include bone marrow aspirations at one week, then at 1, 3, and 6 months to evaluate remission status. Researchers will also monitor adverse events and disease progression. The total study period includes monitoring progression-free and overall survival through an average of 6 to 12 months.

CD123-CD16-NK Cells Immunotherapy for AML