申请企业

Kite Pharma Inc.

药品名称

TECARTUS, brexucabtagene autoleucel

状态

未解决

承诺描述

Conduct a study of brexucabtagene autoleucel treatment of subjects with relapsed or refractory mantle cell lymphoma who have not been exposed to a Bruton tyrosine kinase (BTK) inhibitor. A cohort of subjects naïve to BTK inhibitor therapy will be added to the ongoing ZUMA-2 study to fulfill this requirement. Eighty-six subjects will be enrolled. The primary efficacy endpoint will be objective response rate with a supportive efficacy endpoint of duration of response based on a minimum follow-up of 18 months after first objective disease response. Final Protocol Submission: January 15, 2021 Study/Trial Completion: April 30, 2025 Final Report Submission: October 31, 2025

承诺状态描述

报告接收日期

批准日期

2020/7/24 0:00:00

截止日期

2025/10/31 0:00:00

CDER/CBER

CB

子类型标记

H