Manufacturing validation of biologically functional T cells targeted to CD19 antigen for autologous adoptive cell therapy

D Hollyman, J Stefanski, M Przybylowski… - Journal of …, 2009 - journals.lww.com
On the basis of promising preclinical data demonstrating the eradication of systemic B-cell
malignancies by CD19-targeted T lymphocytes in vivo in severe combined immunodeficient-
beige mouse models, we are launching phase I clinical trials in patients with chronic
lymphocytic leukemia (CLL) and acute lymphoblastic leukemia. We present here the
validation of the bioprocess which we developed for the production and expansion of clinical
grade autologous T cells derived from patients with CLL. We demonstrate that T cells …