autologous PBMCs + GM-CSF

Autologous PBMCs in GM-CSF is a patient-specific cellular immunotherapy that served as the active control arm in the Phase 3 INTUS clinical trial (NCT01875653) for the treatment of Stage III or IV metastatic melanoma. Developed by Lisata Therapeutics (formerly Caladrius Biosciences and NeoStem), the therapy consists of the patient's own peripheral blood mononuclear cells (PBMCs) collected via leukapheresis and subsequently administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF is a hematopoietic growth factor that functions as an immune stimulant by promoting the activation and maturation of antigen-presenting cells. In the trial, this combination was compared against Melapuldencel-T (CLBS20), which added irradiated autologous tumor cells to the dendritic cell component. The development of this specific regimen was terminated in 2016 when the sponsor discontinued the INTUS trial for strategic business reasons.

Other names

Autologous PBMCs in GM-CSFAutologous Peripheral Blood Mononuclear Cells in GM-CSFAutologous PBMCs in GM-CSF (MC)