The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety of CD123-CAR NK cells given to these patients.
This is a study of allogenic CD123-CAR NK cells. The relapsed/refractory AML patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion of CD123-CAR-NK cells. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CD123-CAR-NK is an allogenic CD123-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.
The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose limiting toxicities (DLTs)
Time frame: 1 Months
Treatment-emergent adverse events
Time frame: 3 months
Treatment-related adverse events
Time frame: 3 months
Complete response (CR)
Time frame: 3 months
Progression free survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Proportion of subjects with minimal-residual disease (MRD) negative response
Time frame: 3 months
The area under the concentration time-curve (AUC) of CD123-CAR-NK cells
Time frame: 3 Months
Peak levels of CD123-CAR-NK cells (maximum concentration or Cmax)
Time frame: 3 Months
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