By Fineline Cube Hong Kong-based GenScript Biotech Corporation (HKG: 1548) announced that its subsidiary Legend Biotech Corporation (NASDAQ: LEGN) has terminated a Phase I clinical study for LB1901, a chimeric antigen receptor (CAR) T cell therapy candidate targeting CD4. The decision follows the FDA’s clinical hold in February 2022 and the lifting of that hold in May, with termination now due to lack of clinical benefits in another trial using the same CAR-T construct.
Trial Background
LB1901 was developed to treat relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). The FDA approved the trial in December 2020, and it began in September 2021. Only one patient was enrolled before the trial was halted due to low CD4+ T-cell counts. Despite the hold being lifted, data from an investigator-initiated trial showed insufficient clinical efficacy, prompting the termination.
Company Statement
Legend Biotech stated the termination is based on comprehensive review of the data, prioritizing patient safety and resource allocation to more promising programs. The firm will focus on advancing its other CAR-T candidates, including those targeting BCMA and GPRC5D.-Fineline Info & Tech