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Allogeneic CD56-positive CD3-negative natural killer (NK) cells are a population of immune effector lymphocytes characterized by the expression of the surface marker CD56 and absence of the T-cell marker CD3. These NK cells are derived from healthy donors (allogeneic source), often from hematopoietic stem or progenitor cell sources such as umbilical cord blood or placental tissue. They are expanded and prepared ex vivo for adoptive transfer into patients as an off-the-shelf cell therapy product. Upon infusion, these NK cells can recognize and kill tumor or virally infected target cells through direct cytotoxicity and secretion of cytokines. Their mechanism is independent of antigen specificity, relying on a balance between activating and inhibitory receptors to distinguish abnormal from healthy self-cells. Because they lack T-cell markers (CD3-) and do not cause graft-versus-host disease, they can be used in allogeneic settings without significant risk for this complication. These therapies have been investigated primarily in hematologic malignancies such as acute myeloid leukemia (AML), chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), but also explored in other neoplasms and viral infections like COVID-19[2][5][7]. The product may be manufactured using scalable GMP-compliant processes to yield high-purity populations suitable for clinical use[5].
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