This is a single arm study to evaluate the efficacy and safety of CD123-targeted CAR-T cells therapy for patients with relapsed/refractory Acute Myeloid Leukemia.
There are limited options for treatment of relapse/refractory Acute Myeloid Leukemia. CD123 is expressed on most myeloid leukemia cells so it is an 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 relapsed/refractory Acute Myeloid 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
40
A single infusion of CD123-CAR-T cells will be administered intravenously
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 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 Acute Myeloid Leukemia 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: 6 months
Rate of CD123 CAR-T cells in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) rate of CD123 CAR-T cells were determined by means of flow cytometry
Time frame: 2 years
Quantity of CD123 CAR copies in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) quantity of CD123 CAR copies were determined by means of 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
Levels of cytokines in serum
In vivo (serum) quantity of cytokines
Time frame: 3 months
Duration of Response (DOR) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia
DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)
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Time frame: 2 years
Progress-free survival(PFS) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia
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 year
Overall survival(OS) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia
OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
Time frame: 2 years