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.