This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.
Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Leukemia and Lymphoma to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A single infusion of CD19 and CD22 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 and CD22 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma
The response rate of CD19 and CD22 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline.
Time frame: 6 months
Rate of CD19 and CD22 CAR-T cells in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) rate of CD19 and CD22 CAR-T cells were determined by means of flow cytometry
Time frame: 2 years
Quantity of CD19 and CD22 CAR copies in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) quantity of CD19 and CD22 CAR copies were determined by means of qPCR
Time frame: 2 years
Cellular kinetics of CD19 and CD22 positive cells in Bone marrow
In vivo (bone marrow) rate and quantity of CD19 and CD22 positive cells were determined by means of flow cytometry
Time frame: 1 years
Levels of IL-6 in Serum
In vivo (Serum) quantity of IL-6
Time frame: 3 months
Levels of IL-10 in Serum
In vivo (Serum) quantity of IL-10
Time frame: 3 months
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Levels of TNF-α in Serum
In vivo (Serum) quantity of TNF-α
Time frame: 3 months
Levels of CRP in Serum
In vivo (Serum) quantity of CRP
Time frame: 3 months
Duration of Response (DOR) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed 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)
Time frame: 2 years
Progress-free survival(PFS) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed 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 and CD22 CAR-T treatment in patients with refractory/relapsed 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