Abstract: On February 28, 2022，the U.S. Food and Drug Administration (FDA) approved Ciltacabtagene autoleucel (Cilta-cel) for the treatment of relapsed or refractory multiple myeloma (RRMM) in adults. Cilta-cel is the first FDA-approved cell therapy product in China and the second chimeric antigen receptor (CAR)-T cell immunotherapy to target the B cell maturation antigen (BCMA) approved by FDA around the world. Recent studies have found that patients with RRMM treated with Cilta-cel have an overall remission rate (ORR) of 97%and a 12-month progression-free rate of 77%; common adverse effects include neutropenia, thrombocytopenia, anemia, cytokine release syndrome (CRS), neurotoxicity and so on. In this article, we summarize the mechanism of drug action, indications, pharmacokinetics, clinical studies and adverse effects of Cilta-cel briefly.

Key words: Ciltacabtagene autoleucel, multiple myeloma, B-cell maturation antigen, chimeric antigen receptor