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Autologous regulatory T cell-depleted lymphocytes is an investigational adoptive cell therapy consisting of a patient's own lymphocytes from which the immunosuppressive CD4+CD25+ regulatory T cell (Treg) population has been removed. Regulatory T cells typically function to maintain self-tolerance and suppress immune responses; however, in the context of malignancy, they can infiltrate tumors and inhibit the anti-tumor activity of effector T cells. By depleting these suppressive cells ex vivo, the remaining effector T cells, such as CD8+ cytotoxic T cells and CD4+ helper T cells, are intended to mount a more robust and sustained immune response against tumor cells upon re-infusion. This therapeutic approach is usually administered following a lymphodepleting conditioning regimen (e.g., cyclophosphamide and fludarabine) and is often supported by the administration of high-dose interleukin-2 (IL-2) to promote the expansion and persistence of the infused effector cells. The therapy was primarily developed and evaluated by the National Cancer Institute for the treatment of various refractory metastatic cancers.
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