Allogeneic chimeric antigen receptor natural killer (CAR-NK) cell therapies are gaining rapid momentum as off-the-shelf alternatives to autologous CAR T cell therapies. These platforms combine the innate cytotoxicity of NK cells with engineered specificity, offering promise for scalable manufacturing and reduced risk of graft-versus-host disease.
However, the regulatory landscape for allogeneic CAR-NK products is complex, given the diverse mechanisms of action, source variability (e.g., iPSC-derived NKs), and genome editing components. To navigate these intricacies, regulatory professionals must strategically interpret existing FDA guidance documents on gene therapy, genome editing, potency, and overall CMC practices for IND and BLA.
This article summarizes key considerations across core guidance documents, offering a harmonized view of regulatory expectations for CAR-NK development at clinical stage.
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