NEW YORK – Legend Biotech said on Tuesday that the US Food and Drug Administration has placed a clinical hold on a Phase I study of the firm's autologous CAR T-cell therapy LB1901 for advanced T-cell lymphoma patients.
The Somerset, New Jersey-based firm said that it received an email from the FDA on Friday about the clinical hold, and that the agency will send an official letter with further information by March 11.
LB1901 is designed to target cancerous CD4-positive T-cells. Legend began studying the CAR T-cell therapy in a first-in-human trial in September 2021, and has only treated one enrolled patient so far. According to a statement from Legend, the firm voluntarily paused the trial due to low CD4-positive T-cell counts in this patient's peripheral blood and informed the FDA before it received the agency's email about the formal clinical hold.
"Low CD4 counts are not uncommon in CAR T-cell therapy and approved CAR T-cell therapies show that they can be clinically managed through infection monitoring and prophylaxis and [these cells] can see recovery in 12 to 18 months," Lida Pacaud, Legend's VP of clinical development, said in an email. "The patient in question is … doing well and has not experienced any serious adverse events."
The clinical hold on LB1901 comes just a few weeks before the FDA is expected to decide whether to approve Legend's other CAR T-cell therapy, ciltacabtagene autoleucel (cilta-cel), for patients with relapsed or refractory multiple myeloma. The firm is developing that BCMA-directed autologous CAR T-cell therapy in collaboration with Janssen Biotech.