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FDA places clinical hold on CAR T-cell therapy LB1901 phase I trial in R/R T-cell lymphoma
On February 11, 2022, it was announced that the U.S. Food and Drug Administration (FDA) placed a clinical hold on the phase I LB1901-TCL-001 (NCT04712864) trial of LB1901, a chimeric antigen receptor (CAR) T-cell therapy that is currently under investigation for the treatment of adult patients with relapsed/refractory T-cell lymphoma (TCL).1 An official clinical hold letter will follow by March 11, 2022.
The decision was due to a report regarding the low CD4+ T-cell counts in a patient’s peripheral blood. The patient has not experienced any drug-related serious adverse events and is being monitored in accordance with the protocol.
About LB1901
LB1901 is a novel, investigational, autologous CAR T-cell therapy that targets malignant CD4+ T cells, which are expressed in most TCL subtypes.
The FDA had previously cleared the investigational new drug application for LB1901.
About the LB1901-TCL-001 trial
LB1901-TCL-001 is an open-label, multicenter study investigating the safety, tolerability, and optimal dose of LB1901 for subsequent evaluation. The primary endpoint was safety/tolerability and secondary endpoints included overall response, time to response, duration of response, disease control rate, progression-free survival, and overall survival. To date, only one patient has been dosed with the agent.
References
- Legend Biotech. Legend Biotech announces FDA clinical hold of its phase 1 clinical trial for LB1901. Published February 15, 2022. Accessed February 17, 2022.
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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.
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