CD3/CD7-IT receives Fast Track designation from the FDA for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD)

On the 14th of October 2019, the U.S. Food & Drug Administration (FDA) granted Fast Track designation to CD3/CD7-IT, for the treatment of SR-aGvHD in patients following allogeneic stem cell transplantation (allo-SCT).1 CD3/CD7-IT received Orphan Drug Designation in the US for the treatment of graft-vs-host disease (GvHD) in 2013.2

CD3/CD7-IT is designed to reset the body's immune system in life-threatening T cell‒mediated conditions and consists of combination of two antibodies (directed against T-cell antigens CD3 and CD7) both conjugated to an immunotoxin. CD3/CD7-IT has demonstrated in vivo depletion of mature T cells and NK cells with minimal treatment-related side effects, in preclinical and early phase studies.1

The FDA approval is based on a phase I/II study that showed that one week of CD3/CD7-IT treatment triggered a strong clinical response and doubled the six-month overall survival rate in SR-aGVHD patients.3

A US Phase III trial involving patients with SR-aGVHD following allo-SCT will soon begin.

  1. Yahoo. Xenikos receives FDA Fast Track designation for T-Guard(R) for treating steroid-refractory acute graft-versus-host disease. Weblink [Accessed 22 Oct 2019]
  2. Xenikos. T-Guard® Receives Orphan Drug Designation for Treatment of Graft versus Host Disease (GVHD) in the US [Accessed 22 Oct 2019]
  3. Groth C. et al., Phase I/II Trial of a Combination of Anti-CD3/CD7 Immunotoxins for Steroid-Refractory Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2019 Apr;25(4):712-719. DOI: 10.1016/j.bbmt.2018.10.020
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