UPDATED: Legend scraps trial of its follow-up autologous CAR-T weeks after clinical hold was lifted
Six weeks after getting its clinical hold lifted, Legend Biotech has decided to terminate the Phase I study of its CAR-T targeting CD4+.
The news was tucked into an SEC filing, and Legend confirmed to Endpoints News in an email that the US study of LB1901 was scrapped, as well as a separate investigator-initiated Phase I study in China of a similar product (LCAR-T2C) using the same CAR protein.
Only one patient had been enrolled in Legend’s Phase I study and the biotech never resumed the trial after the February clinical hold was lifted in late-May, a company spokesperson told Endpoints.
“The decision to terminate the program was made based on a lack of clinical benefit from a similar Legend Biotech CAR-T product candidate that expressed the same CAR protein as LB1901 and a desire to prioritize other product candidates in our pipeline,” VP of clinical development Lida Pacaud told Endpoints in an emailed statement.
LB1901 is an autologous CAR-T that was being tested in patients with relapsed or refractory T-cell lymphoma. The trial had expected to enroll 50 patients and complete primary outcome data collection in December 2023, according to the federal trials database.
LB1901 was cleared for an IND in December 2020, and the trial began in September 2021. After enrolling only one patient — who showed low CD4+ T-cell counts — the FDA placed a clinical hold on the study in February. The agency said the IND did not “contain sufficient information required” to assess the therapy’s risks to patients.
The one patient to have received LB1901 “continues to do well and has not experienced any serious adverse events,” a Legend spokesperson said in an email to Endpoints. The patient had failed two prior lines of therapy.
The treatment, which takes cells from the patient, was the furthest in the pipeline behind Legend and partner Johnson & Johnson’s Carvykti, the second BCMA CAR-T approved by the FDA, which is also authorized in Europe for patients with multiple myeloma.
Further down the pipeline, Legend received FDA clearance last month to begin a Phase I trial of LB1908, another autologous CAR-T. The treatment selectively targets Claudin18.2 and will be tested in patients with relapsed or refractory gastric, esophageal and pancreatic cancers.
Editor’s note: This story was updated to include additional information from a Legend spokesperson.