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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.
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