This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
RECRUITINGPercentage of adverse events
Percentage of participants with adverse events
Time frame: 6 months
complete remission rate
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
Time frame: 6 months
objective remission rate
The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).
Time frame: 6 months
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