On the 7 thof November 2019, TAC01-CD19 was granted Fast Track designation by the U.S. Food and Drug Administration(FDA) for use in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after at least 2 prior systemic therapies. 1
TAC01-CD19 is a T cell antigen coupler (TAC) that is distinct from chimeric antigen receptor T cells (CAR-T). This TAC receptor product employs patient-derived genetically engineered T cells to target CD19, a B-cell marker expressed on the surface of B-cell tumors, independent of the Major Histocompatibility Complex. 2Preclinical data indicate that TAC01-CD19 could be highly efficacious without treatment-associated toxicity in animal models of CD19-positive B-cell malignancies. 3
A phase I/II study (TACTIC-19) NCT03880279evaluating the efficacy and safety of TAC01-CD19 in patients with CD19-positive B-cell malignancies including DLBCL is anticipated to start by the end of 2019.