The GvHD Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

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

Oct 22, 2019

On the 14 thof 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). 1CD3/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 vivodepletion 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
More about...


Subscribe to get the best content related to GvHD delivered to your inbox every month