FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

Wugen Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, announced it will initiate a phase II study in the first quarter of 2025 for the company’s potential first-in-class, investigational, anti-CD7 CAR T-cell therapy, WU-CART-007, in patients with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.