Relmacabtagene autoleucel (relma‐cel) CD19 CAR‐T therapy for adults with heavily pretreated relapsed/refractory large B‐cell lymphoma in China

摘要

Despite numerous chimeric antigen receptor T‐cell (CAR‐T) trials conducted in China, no CAR‐T has been registered in the country. Furthermore, China law and regulations restrict the export of patient material for CAR‐T manufacture abroad. Relma‐cel (JWCAR029), an anti‐CD19 product produced with a commercial‐ready process in China, was evaluated in the first prospective, single‐arm, multicenter, pivotal study of CAR‐T therapy conducted under Chinese IND to support an NMPA‐accepted BLA submission in relapsed/refractory (r/r) LBCL ({"type":"clinical-trial","attrs":{"text":"NCT04089215","term_id":"NCT04089215"}}NCT04089215).