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pp65-specific TCR-T cells are an adoptive cellular immunotherapy consisting of T cells genetically engineered to express a high-affinity T-cell receptor (TCR) specific for the cytomegalovirus (CMV) phosphoprotein 65 (pp65). Developed by BriStar Immunotech in collaboration with Beijing Yongtai Ruike Biotechnology and The First Affiliated Hospital of Soochow University, this therapy is designed to treat refractory CMV infection or reactivation in immunocompromised patients, particularly those undergoing hematopoietic stem cell transplantation (HSCT). The engineered T cells recognize pp65 antigen peptides presented by MHC molecules on the surface of CMV-infected cells, leading to targeted cytotoxic killing and viral clearance. A Phase I clinical trial (NCT04153279) conducted at Hebei Yanda Lu Daopei Hospital demonstrated that the therapy was well-tolerated and achieved complete responses in patients with CMV reactivation post-HSCT.
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