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This combination immunotherapy regimen, developed by the Baylor College of Medicine, consists of an autologous tumor cell vaccine and the immunomodulatory drug lenalidomide for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). The vaccine component is created by genetically modifying a patient's own B-CLL cells in vitro to express Interleukin-2 (IL-2) and human CD40 ligand (CD40L/CD154). IL-2 acts as a potent T-cell growth factor to stimulate anti-tumor immunity, while CD40L expression enhances the antigen-presenting capacity of the leukemia cells. Lenalidomide is co-administered to modulate the immune microenvironment, specifically by reducing the population of immunosuppressive regulatory T cells (Tregs), with the goal of extending the duration and efficacy of the vaccine-induced immune response. This therapeutic strategy was investigated in the Phase 1 TAIL clinical trial.
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