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This autologous CAR-T cell therapy is developed by the Institute of Hematology and Blood Transfusion (IHBT) in Prague, Czech Republic, for the treatment of B-cell malignancies. The therapy consists of patient-derived T lymphocytes genetically modified to express a chimeric antigen receptor (CAR) targeting the CD19 antigen. Notably, the manufacturing process utilizes a non-viral approach based on the piggyBac transposon technology, where T cells are electroporated with transposon vectors rather than being transduced with viral vectors. The cells are expanded in a specific cytokine environment containing IL-4, IL-7, and IL-21 to promote the development of early memory T cell phenotypes, which are associated with improved persistence and efficacy. It is currently being evaluated in a Phase I clinical trial for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin's lymphoma (B-NHL).
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