Cullinan Therapeutics 获得 FDA 批准用于狼疮治疗的 CLN-978 1 期试验。 Cullinan Therapeutics receives FDA clearance for CLN-978 Phase 1 trial in lupus treatment.

Cullinan Therapeutics 的 CLN-978 研究性新药申请已获得 FDA 批准，CLN-978 是一种新型 CD19 T 细胞接合剂，旨在治疗中度至重度系统性红斑狼疮 （SLE）。 Cullinan Therapeutics has obtained FDA clearance for its Investigational New Drug application for CLN-978, a novel CD19 T cell engager aimed at treating moderate to severe systemic lupus erythematosus (SLE). 这项批准允许该公司在美国进行第一阶段临床试验,以评估该药物对病人的安全和功效,解决未满足的大量狼疮治疗需要。 This approval allows the company to proceed with a Phase 1 clinical trial in the U.S. to assess the drug's safety and efficacy in patients, addressing significant unmet needs in lupus treatment.