B-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.
Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will
be determined at entry phase,. Subjects will be collected large numbers of peripheral blood
mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the
PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to
subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19
cells at regular intervals through four weeks after their last infusion of the study.
Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two
years with a physical examination, blood tests, bone marrow aspirate, minimal residual
disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be
evaluated health problems every year for an additional thirteen years.
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