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CD19-CAR.CD45RA-negative T-cells is an investigational allogeneic CAR-T cell therapy developed for the treatment of relapsed or refractory CD19-positive leukemia, particularly in pediatric and young adult populations. The therapy utilizes a unique manufacturing process involving the depletion of CD45RA-positive (naive) T-cells from a donor (either a prior stem cell donor or a family member), leaving a population of memory T-cells. These memory T-cells are then engineered to express a second-generation chimeric antigen receptor (CAR) targeting the CD19 antigen, incorporating a 4-1BB (CD137) costimulatory domain and a CD3-zeta signaling domain. By removing naive T-cells, the therapy aims to reduce the risk and severity of graft-versus-host disease (GVHD) while maintaining the potent anti-leukemic activity and persistence associated with memory T-cells in an allogeneic setting.
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