TBI-1301 + cyclophosphamide

TBI-1301 + cyclophosphamide is a **combination therapy** consisting of **TBI-1301**, an autologous T cell product genetically engineered to express a high-affinity T cell receptor (TCR) against the cancer-testis antigen NY-ESO-1 (with endogenous TCR silenced via siRNA), and **cyclophosphamide**, a chemotherapeutic agent used for lymphodepletion prior to cell infusion. TBI-1301 is manufactured from the patient’s own leucocytes, targeting NY-ESO-1-positive tumor cells—especially in synovial sarcoma. The therapy involves intravenous split dosing of TBI-1301 (5 x 10⁹ cells over 2 days) following cyclophosphamide (750 mg/m² once daily for 2 days). Cyclophosphamide serves to reduce host lymphocytes and enhance the engraftment and function of the infused engineered T cells. Primary indication is unresectable, anthracycline-refractory, NY-ESO-1-positive synovial sarcoma. Safety endpoints include adverse events (CRS occurred in 50% of patients, all manageable), and efficacy endpoints include a ~50% objective response rate in phase I/II studies[1][2][3][4][5].

Brand names

mipetresgene autoleucel

Other names

NY-ESO-1 antigen-specific T-cell receptor gene therapy + cyclophosphamide