CARsgen Therapeutics Holdings Limited announces that the Company has received a no-objection letter from Health Canada in relation to the entry into the Phase II trial of CT053 (an autologous CAR-T product candidate against BCMA). CT053 is an upgraded, fully-human autologous BCMA CAR-T product candidate for the treatment of refractory and/or relapsed multiple myeloma. It incorporates an upgraded CAR construct engineered by CARsgen 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. CARsgen has completed the Phase I trials and is conducting the pivotal Phase II portion of a Phase I/II clinical trial (LUMMICAR STUDY 1) in China and a Phase 1b/2 clinical trial (LUMMICAR STUDY 2) in North America to evaluate the safety and efficacy of CT053 for refractory and/or relapsed multiple myeloma. CARsgen plans to make regulatory submissions for marketing approval to the NMPA in the first half of 2022 and to 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 multiple myeloma.