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Legend Biotech Shutters Trial of CD4-Directed CAR T-Cell Therapy for T-Cell Lymphoma

NEW YORK – Legend Biotech said last week in a form 6-K filed with the US Securities and Exchange Commission that it has terminated a Phase I clinical trial evaluating its CD4-targeted CAR T-cell therapy LB1901 for relapsed or refractory T-cell lymphomas.

The news comes after the US Food and Drug Administration placed a clinical hold on the trial in February. At the time, Lida Pacaud, Legend's VP of clinical development, told Precision Oncology News that the pause was due to one patient showing low CD4 cell counts. But the following month, the FDA sent a letter informing Legend that its investigational new drug application "did not contain sufficient information required … to assess the risks to subjects."

In late May, the FDA lifted the clinical hold, which Legend announced in its first quarter earnings report.

However, in its latest filing with the SEC, the Somerset, New Jersey-based firm laid out several reasons for deciding to end the study. For one, Legend said that in an investigator-initiated clinical trial in China, a therapy expressing the same CAR protein as LB1901 demonstrated limited efficacy. Additionally, the firm said it wants to prioritize development of other products in its pipeline.

Legend, in collaboration with Janssen, developed the CAR T-cell therapy Carvykti (ciltacabtagene autoleucel), which has both FDA and European Commission approval for multiple myeloma. Legend is also developing other investigational cell therapies, including candidates to treat solid tumors such as gastric, pancreatic, and non-small cell lung cancer.