Gracell Biotechnologies: FDA Clears IND Application For Phase 1/2 Trial Of FasTCAR-T GC012F

(RTTNews) - Gracell Biotechnologies Inc. (GRCL) announced the FDA has cleared Investigational New Drug application, allowing the company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus.

GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen and CD19 and utilizes FasTCAR next-day manufacturing platform. The Phase 1 portion of the Phase 1/2 clinical trial evaluating GC012F in rSLE will be initiated in 2024 and is designed to assess the safety and tolerability of GC012F, determine the recommended dose for Phase 2 study and characterize the pharmacokinetics of GC012F.

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