Gates Institute Achieves Historic FDA Clearance for Campus-Developed CAR T-Cell Therapy

The Gates Institute at the University of Colorado Anschutz has received clearance from the U.S. Food and Drug Administration (FDA) to advance a novel CAR T-cell therapy into clinical testing for adults with relapsed or refractory acute myeloid leukemia. The milestone represents the first U.S. authorization for clinical testing of a CAR T-cell therapy targeting CD64, a protein associated with aggressive leukemia cells.

The treatment was developed entirely at CU Anschutz and will be manufactured at the Gates Biomanufacturing Facility, located within Fitzsimons Innovation Community. The achievement highlights the importance of specialized biomanufacturing infrastructure in translating scientific discoveries into potential treatments, connecting university research with the advanced manufacturing capabilities needed to support clinical trials.

Read the full announcement: The University of Colorado Anschutz Gates Institute Achieves First-in-U.S. FDA Clearance for Campus-Built CAR T-Cell Therapy

Source: University of Colorado Anschutz