Sofi-cel (WU-CART-007): A CRISPR-Edited, Off-the-Shelf Anti-CD7 CAR-T Advancing Through FDA Expedited Pathways
SOPHIA ANTIPOLIS, France – March 2nd, 2026 │ Wugen has received Breakthrough Therapy Designation from the U.S. FDA for its investigational CAR-T cell therapy, Sofi-cel, for patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). In these cancers, relapses remain a major challenge. These aggressive T-cell malignancies[…]