This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.
There are limited options for treatment of relapse/refractory CD19+ B Cell Leukemia and Lymphoma. CD19 is expressed on most CD19+ B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma. 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 CD19-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 CD19 CAR-T treatment in patients with relapse/refractory CD19+ B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy
The response rate of CD19 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
Time frame: 6 months
Rate of CD19 CAR-T cells in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) rate of CD19 CAR-T cells were determined by means of flow cytometry
Time frame: 2 years
Quantity of CD19 CAR copies in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) quantity of CD19 CAR copies were determined by means of qPCR
Time frame: 2 years
Cellular kinetics of CD19 positive cells in bone marrow
In vivo (bone marrow) rate and quantity of CD19 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 CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma
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 CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma
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 CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma
OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
Time frame: 2 years