The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China
CAR T cell persistence
Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood
Time frame: up to 24 months
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Time frame: up to 24 months
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