Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of B cell lymphoma.
A non randomized study ,plans to enrollment 24 subjects of B cell lymphoma .The subjects will divide into low, medium and high dose groups,to evaluate the safety and tolerability of CD19-CD22 CAR - T cells,to evaluate the preliminary efficacy and observe PK/PD parameters of CD19-CD22 CAR -T cells immunotherapy in patients with relapsed or refractory B cell lymphoma .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A autologous doping CAR - T cells injection targets with CD19 and CD22,fluorine dara marina injection(30 mg/m2,QD×3d) and cyclophosphamide injection (300 mg/m2,QD×3d)will be used to remove the lymphocyte before infusion CD19-CD22 CAR-T cells .
Hematology Department of ShanXi Cancer Hospital
Taiyuan, Shanxi, China
RECRUITINGDLT
Observe wether dose limiting toxicity will happened in dose escalation phase
Time frame: Form infusion CAR-T cells to 28 days after infusion
ORR
The overall response rate after CD19-CD22 CAR-T Cells immunotherapy
Time frame: Form infusion CAR-T cells to 2 years after infusion
Incidence of various types of adverse recation
According to CTCAE 5.0, record the level , type of adverse events, evaluat the correlation of CD19-CD22 CAR-T cells
Time frame: Form infusion CAR-T cells to 2 years after infusion
PFS
Progression-free surial
Time frame: Form infusion CAR-T cells to 2 years after infusion
DOR
Duration of Response
Time frame: Form infusion CAR-T cells to 2 years after infusion
OS
Overall survival
Time frame: Form infusion CAR-T cells to subjects died,assessed up to 60 months
Cmax
By measuring the CAR - T cells copy number and the positive rate, peak plasma concentration is determined
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Tmax
The maximum concentration of time
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Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
AUC(0-720d)
Area under the plasma concentration versus time curve
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL2 level
The levels of cytokines(IL2 )in peripheral blood
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL6 level
The levels of cytokines(IL6 )in peripheral blood
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IL10 level
The levels of cytokines( IL10 )in peripheral blood
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of TNF-α level
The levels of cytokines(TNF-α)in peripheral blood
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24
Concentration of IFN-γ level
The levels of cytokines(IFN-γ )in peripheral blood
Time frame: Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24