TBI-0301

TBI-0301 is a gene-modified cell therapy consisting of donor lymphocytes transduced with the Herpes Simplex Virus Thymidine Kinase (HSV-TK) suicide gene. Developed by Takara Bio, it is designed for use as a donor lymphocyte infusion (DLI) in patients with hematologic malignancies (such as leukemia, lymphoma, and myelodysplastic syndrome) who have relapsed or are at high risk of relapse after allogeneic hematopoietic stem cell transplantation (HSCT). The inclusion of the HSV-TK gene serves as a safety switch; if the patient develops severe graft-versus-host disease (GvHD), the administration of ganciclovir can selectively eliminate the gene-modified donor cells by converting the prodrug into a toxic metabolite. This approach aims to preserve the graft-versus-leukemia (GvL) effect while providing a manageable safety profile for DLI.

Other names

HSV-TK gene-transduced donor lymphocytesHSV-TK gene-modified donor lymphocytes