CARsgen Therapeutics Holdings Limited announced that the first subject has been enrolled and dosed in the pivotal Phase II trial of CT053 in North America. CT053 is an upgraded, fully-human autologous BCMA CAR-T product candidate for the treatment of refractory and/or relapsed multiple myeloma (R/R MM). It incorporates an upgraded CAR construct engineered that features a fully-human BCMA-specific single-chain fragment variant with lower immunogenicity and increased stability, which reduces the auto-activation of CAR-T cells in the absence of tumor associated targets. It have completed the Phase I trials and are conducting the pivotal Phase II trial portion of a Phase I/II clinical trial of CT053 for R/R MM in China (LUMMICAR STUDY 1) and in North America (LUMMICAR STUDY 2) to evaluate the safety and efficacy of CT053. Its plan to make regulatory submissions for marketing approval to the NMPA in the first half of 2022 and the U.S. FDA in the first half of 2023, as well as to conduct additional clinical trials to develop CT053 as an earlier line of treatment for MM. CT053 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019, as well as PRIority MEdicines (PRIME) and Orphan Medicinal Product designations from the EMA in 2019 and 2020, respectively, and the Breakthrough Therapy designation from the NMPA in 2020. It believe that CT053, the BCMA CAR-T product candidate with an upgraded, fully-human CAR, has a promising efficacy profile and a favorable safety profile, as evidenced by the absence of Grade 3 or higher Cytokine Release Syndrome and absence of treatment-related patient deaths in the investigator initiated trials and the Phase I clinical trials.