nalotimagene carmotel

Nalotimagene carmotel (Zalmoxis) is an advanced therapy medicinal product (ATMP) consisting of donor-derived T lymphocytes genetically engineered to express the Herpes Simplex Virus thymidine kinase (HSV-TK) suicide gene and a truncated low-affinity nerve growth factor receptor (ΔLNGFR) selection marker. Developed by MolMed, it is designed as an adjunct treatment for adult patients undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) for high-risk hematologic malignancies, such as acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The therapy aims to accelerate immune reconstitution post-transplant while providing a safety mechanism: the HSV-TK gene makes the transduced T cells sensitive to ganciclovir. If graft-versus-host disease (GvHD) occurs, administration of ganciclovir selectively eliminates the engineered cells, allowing for the control of GvHD without the need for systemic immunosuppression. Although it received conditional marketing authorization from the EMA in 2016, the authorization was withdrawn in 2019 at the sponsor's request due to challenges in completing the required Phase III confirmatory trial.

Brand names

Zalmoxis

Other names

HSV-TK–transduced donor lymphocytesHSV-TK/ΔLNGFR–modified donor lymphocyte infusionsHerpes simplex virus thymidine kinase-transduced donor lymphocytes