This is a single arm, open-label, multi-center study to determine the efficacy and safety of an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell ALL.
This is a single arm, open-label, multi-center, phase I study to determine the efficacy of CTL019 in patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Primary Follow-up, Secondary Follow-up (if applicable) and Survival Follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2 to 5 x 10(6) autologous CART-19 transduced cells per kg body weight, with a maximum dose of 2.5 x 10(8) autologous CTL019 transduced cells via intravenous infusion.
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGNumber of Adverse Events
Time frame: 2 years
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