Weekly Digest - 01-07 Apr 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 01-07 Apr 2023
04 Apr 2023: GB5121 / Primary CNS lymphoma / Gossamer Bio: Developement discontinued following two patient deaths
- Following two patient deaths in the Phase 1b/2 STAR-CNS study, the company has decided to discontinue the development of the GB5121 lymphoma candidate
- FDA had placed a partial clinical hold on all studies of GB5121 due to the serious adverse events in the STAR-CNS study
- Serious adverse events reported were an episode of fatal intracranial hemorrhage, a case of atrial fibrillation, and one sudden death
- GB5121 in an open-label Phase 1b/2 study enrolling patients with advanced cases of CNS lymphoma, the company signaled problems with this trial last month and hence decided to pause enrollment due to the drug’s observed risk/benefit profile
