nalotimagene carzadenotucel

Nalotimagene carzadenotucel (Zalmoxis) is a cell-based gene therapy developed by MolMed (now AGC Biologics) for adults with high-risk acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) undergoing haploidentical hematopoietic cell transplantation (HCT). The therapy consists of allogeneic T lymphocytes from the same donor as the transplant, which have been genetically modified ex vivo using a retroviral vector to express the Herpes Simplex Virus Thymidine Kinase (HSV-TK) suicide gene and a truncated human low-affinity nerve growth factor receptor (ΔLNGFR) as a selection marker. These engineered cells are infused post-transplant to accelerate immune reconstitution and provide a graft-versus-leukemia effect. The HSV-TK gene serves as a safety switch; if the patient develops severe graft-versus-host disease (GvHD), the administration of ganciclovir selectively kills the modified T cells, thereby controlling the GvHD. Although it received conditional marketing authorization from the EMA in 2016, the authorization was withdrawn in 2019 for commercial reasons following the termination of the Phase III TK008 trial.

Brand names

Zalmoxis

Other names

HSV-TK donor lymphocytesHSV-TK gene-transduced donor T lymphocytesnalotimagene carzadenotucel