There are limited options for treatment of relapse/refractory acute myeloid leukemia (AML). CD123 CAR-T cells may have an attractive and permanent effect on anti-tumor. This study purpose to estimate the safety and efficiency of CD123 CAR-T cells to patients with relapse/refractory AML.
CD123 is expressed on most myeloid leukemia cells so it is a ideal target for CAR-T. Some researches have revealed that CD123 is a marker of leukemia stem cells, which indicates that the eradication of CD123 cells may prevent relapse of leukemia. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD123 in patients with Acute Myelocytic Leukemia. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
CD123 CAR-T cell therapy
920th Hospital of Joint Logistics Support Force
Kunming, Yunnan, China
RECRUITINGAdverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time frame: 2 years
The response rate of CD123 CAR-T treatment in patients with relapse/refractory AML that treatment by CD123 CAR-T cells therapy
The response rate of CD123 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline.
Time frame: 2 years
Cellular kinetics of CD123 CAR-T in Blood
In vivo (peripheral blood) rate and quantity of CD123 CAR-T cells were determined by means of flow cytometry and qPCR
Time frame: 2 years
Cellular kinetics of CD123 CAR-T in Bone marrow
In vivo (bone marrow) rate and quantity of CD123 CAR-T cells were determined by means of flow cytometry and qPCR
Time frame: 2 years
Cellular kinetics of CD123 positive cells in Bone marrow
In vivo (bone marrow) rate and quantity of CD123 positive cells were determined by means of flow cytometry
Time frame: 1 years
Duration of Response (DOR) of CD123 CAR-T treatment in patients with refractory/relapsed AML
DOR will be assessed from the first assessment of CR or CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)
Time frame: 2 years
Progress-free survival(PFS) of CD123 CAR-T treatment in patients with refractory/relapsed AML
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PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Time frame: 2 years
Overall survival(OS) of CD123 CAR-T treatment in patients with refractory/relapsed AML
OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
Time frame: 2 years