Innovative CAR-T cell therapy receives FDA Breakthrough Therapy designation

April 16, 2026

You funded it! Breakthrough research at Siteman Cancer Center and the Washington University School of Medicine, powered by early investment from Pedal the Cause, has helped advance a groundbreaking CAR-T therapy that has now earned Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). This treatment targets rare, aggressive T-cell cancers where patients have had little hope.

That support led to an “off-the-shelf” CAR-T therapy—ready when patients need it—overcoming major barriers in treating these cancers. In early trials, most patients saw their cancer go into remission, even after other treatments failed. The therapy’s FDA Breakthrough designation is accelerating its path forward and delivering real hope, faster.

“This therapy has the potential to enable long-term survival for this patient population by controlling the disease and allowing patients — who would otherwise not be eligible — to proceed to stem cell transplantation, the only potentially curative treatment for these blood cancers,” said WashU Medicine oncologist John F. DiPersio, MD, PhD, the Virginia E. & Sam J. Golman Professor of Medicine and director of WashU Medicine’s Center for Gene and Cellular Immunotherapy, who first developed the therapy in his lab.

This is the Pedal model in action: funding bold ideas early to drive life-saving impact. What started as a high-risk concept is now on a fast track to save lives worldwide.

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