The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to WU-CART-007, an off-the-shelf CAR-T therapy for aggressive T-cell blood cancers. Developed at Washington University School of Medicine and licensed to Wugen, the therapy targets T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Early clinical data show a 91% overall response rate, with nearly 73% of patients achieving complete remission. The therapy also enabled patients previously ineligible for stem cell transplantation to proceed to curative treatment. Unlike traditional CAR-T therapies, WU-CART-007 uses healthy donor cells, allowing rapid treatment. Researchers engineered the therapy to prevent T cells from attacking each other, a common challenge in T-cell cancers.
The Breakthrough Therapy designation will speed development and regulatory review. Phase 2 trials are underway at Siteman Cancer Center and other sites worldwide to evaluate efficacy in both adult and pediatric patients.