TK54

TK54 is an investigational genetically modified cell therapy developed for the management of graft-versus-host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for hematological malignancies, such as acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The therapy consists of donor-derived T lymphocytes that are genetically engineered ex vivo to express a "suicide gene," specifically a variant of the Herpes Simplex Virus Thymidine Kinase (HSV-TK). This suicide gene serves as a safety switch; if the patient develops severe or uncontrolled GVHD following the infusion, the administration of the antiviral drug ganciclovir triggers the selective apoptosis of the modified T-cells. This approach is designed to allow for the safer administration of donor lymphocytes to promote rapid immune reconstitution and enhance the graft-versus-leukemia (GVL) effect while providing a pharmacological mechanism to mitigate the risks of GVHD. TK54 received Orphan Drug Designation and Advanced Therapy Medicinal Product (ATMP) status from the European Medicines Agency (EMA) and reached Phase I/II clinical trials before development was discontinued.

Other names

HSV-TK modified T-cellsLTKfarma TK54