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On December 8, Kozi Bio announced that its CT053 all-human anti-BCMA in vitro CAR T cell injection was incorporated into the breakthrough therapeutic drug variety through the CDE publicity period, and that the adaptive disorder was formulated as recurring refractic multiple myeloma (R/R MM).
breakthrough treatment information CT053 is a CAR T cell therapy for B-cell mature antigens (BCMA).
CT053 construct uses the whole human anti-BCMA single-stranded antibody domain, presumably to reduce immunogenicity and improve safety.
CT053 is thought to identify, bind and remove multiple myeloma cells that express BCMA.
at its 62nd annual meeting of the American Society of Hematology (ASH), Kozi Bio released the latest safety and ability results from CT053's ongoing global clinical studies, including 2 oral reports and 1 wall paper exchange.
three studies, involving 58 R/R MM patients from China and the United States, showed good tolerance for CT053 and significant and lasting relief in patients who experienced multiple-line treatment failures.
noted that CT053 is the first cell therapy candidate to receive advanced regenerative medicine therapy (RMAT) from the FDA in China and is included in the Priority Medicines (PRIME) program by the European Medicines Agency.
note: There are deletions in the original text