The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.
CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.
Huaian First People's Hospital
Huai'an, Jiangsu, China
RECRUITINGAffiliated hospital of Xuzhou medical college
Xuzhou, Jiangsu, China
RECRUITINGCAR-T cells persistence in peripheral blood
The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR
Time frame: 12 months
B cell number and immunoglobulins in peripheral blood
The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods
Time frame: 12 months
JunNian Zheng, M.D., Ph.D.
CONTACT
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