This is a single center, single arm, open-label phase 1 study to determine the safety and efficacy of autologous T cells expressing CD19 chimeric antigen receptors in adults with CD19+ B cell malignancies.
This is a single-center, Open Label phase I clinical trial, 9 subjects planned to be enrolled. The subjects will be divided into low-dose group, medium-dose group and high-dose group.Dose CAR+ cells/kg Low 1×105 Medium 2×106 High 6×106
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion. Subjects will receive 0.1-10 x 10\^6 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction, Day 2, 30% fraction, Day 3, 60% fraction.
Shanghai Tong Ren hospital
Shanghai, China
RECRUITINGFrequency and severity of toxicities and adverse events
To assess the frequency and severity of toxicities and adverse events according to NCI CTC v4.0
Time frame: 24 weeks
overall response rate
To assess the overall response rate after CD19 CAR T infusion in R/R B cell malignancies
Time frame: 24 week
overall survival
To assess the overall survival in patients with R/R B cell malignancies
Time frame: 24 week
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