GC012F is an autologous, genetically engineered, bispecific CAR-T that targets B-cell maturation antigen and CD19 proteins on the surface of cancer cells. The new cell therapy, which has previously received FDA orphan drug designation, is manufactured within 24 hours of apheresis using Gracell’s proprietary FasT CAR platform. A single dose of an investigational chimeric antigen receptor T-cell therapy induced an objective response in up to 90% of patients with relapsed or refractory multiple myeloma, results from the Phase 1 study showed. Data from the trial, presented at the ASCO Annual Meeting, indicated that the agent had a manageable safety profile. Twenty-five (89.3%) of the 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 or a strict complete response to treatment. Twenty-four (86%) patients had a very good partial response or better. Researchers reported few cases of high-grade cytokine release syndrome and no treatment-related neurotoxicity.
