mp.weixin.qq.com· 医麦创新药·· 9 hours agoPickScore53
Legend Biotech LB2501 Becomes First Dual-Target In Vivo CAR-T to Clear FDA IND
首个！传奇生物 CD19/CD20 双靶点 in vivo CAR-T 获 FDA IND 许可
In brief
The FDA has cleared an IND for Legend Biotech's LB2501, an off-the-shelf in vivo CAR-T therapy designed to generate CD19/CD20 dual-target CAR-T cells in patients through a single infusion. The indication is relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma (B-NHL). Per the company's announcement, LB2501 is the first known dual-target in vivo CAR-T to receive FDA IND clearance. The clearance supports a phase 1/2 trial in the United States evaluating safety, tolerability, pharmacokinetics and preliminary efficacy.
Why it matters
It is the first known FDA IND clearance for a dual-target in vivo CAR-T therapy.
Source: mp.weixin.qq.com · mp.weixin.qq.com