Posted by Michael Wonder on 21 Jan 2026
US FDA grants to Wugen’s WU-CART-007 breakthrough therapy designation for treatment of relapsed or refractory T cell acute lymphoblastic leukaemia / T cell lymphoblastic lymphoma
21 January 2026 - Wugen today announced that it has received breakthrough therapy designation from the US FDA for its investigational CAR-T cell therapy, Sofi-cel.
Sofi-cel is an investigational, potential first in class, allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial for patients with relapsed or refractory T cell acute lymphoblastic leukaemia or T cell lymphoblastic lymphoma.
