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T cell antigen coupler (TAC) therapy - TAC01-CD19 - granted Fast Track designation by the FDA for the treatment of patients with R/R DLBCL

Nov 11, 2019

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.

  1.[Accessed  November 8, 2019]
  2. Helsen CW. et al., Preclinical development of TAC01-CD19, a CD19 specific T-cell Antigen Coupler (TAC) therapy for the treatment of CD19-positive B cell malignancies. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res2019;79(13 Suppl): Abstract nr 1424. DOI: 10.1158/1538-7445.AM2019-1424
  3. Helsen CW. et al., The chimeric TAC receptor co-opts the T cell receptor yielding robust anti-tumor activity without toxicity. Nat Commun. 2018 Aug 3;9(1):3049. DOI: 10.1038/s41467-018-05395-y