Recurrent B-Cell Tumor Clinical Trial
Official title:
A Clinical Study Using Autologous T Cell Engineered With Chimeric Antigen Receptor Targeting to CD19（Cluster of Differentiation Antigen 19) in Treating Patients With Recurrent /Refractory B Cell Leukemia
Objectives:
The purpose of this study is to evaluate the safety and prognosis of New Cluster of
Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of
recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.
Methods:
This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled.
Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4
days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According
to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks
long. Follow-up survey after the clinical study: within 1 months, once a week; then once a
month for 1 years; and then once a year, a total of 15 years.
A total of 20 patients may be enrolled over a period of 1-2 years. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment