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This combination therapy consists of ex vivo expanded and activated haploidentical natural killer (NK) cells and the immunocytokine lorukafusp alfa (hu14.18-IL2). The NK cells are harvested from a haploidentical donor and expanded using a specific manufacturing process involving a K562 feeder cell line expressing membrane-bound interleukin-15 (mbIL15) and 4-1BBL to enhance their proliferation and cytotoxic potential. Lorukafusp alfa is a recombinant fusion protein comprising a humanized monoclonal antibody (hu14.18) targeting the disialoganglioside GD2, fused to two molecules of interleukin-2 (IL-2). The antibody component directs the therapy to GD2-expressing tumor cells, such as those found in neuroblastoma and osteosarcoma, while the IL-2 component provides localized activation and expansion of the infused NK cells. This synergistic approach aims to induce potent antibody-dependent cellular cytotoxicity (ADCC) and direct tumor cell lysis, particularly in patients with relapsed or refractory disease.
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