GC012F (Gracell Biotechnologies) is an autologous, genetically engineered, bispecific CAR-T that targets B cell maturation antigen (BCMA) and CD19 proteins on the surface of cancer cells. BCMA is universally expressed on malignant plasma cells and is a well-established target for multiple myeloma, while CD19 is expressed on both myeloma cells and their progenitor cells. The new cell therapy, which previously received FDA orphan drug designation, is manufactured within 24 hours of apheresis using Gracell’s proprietary FasT CAR platform. The investigators chose to use a dual-targeted CAR-T manufactured in one day or less for this study population of heavily pre-treated multiple myeloma patients to reduce the risk of disease progression prior to CAR-T infusion. Twenty-five (89.3%) of 28 patients achieved objective treatment responses after a single infusion of GC0-12F, including 21 (75%) with a negative complete response to minimal residual disease (MRD) or a strict complete response to treatment. Twenty-four (86%) patients had a very good partial response or better.
