Early-Phase Trial Assessing Novel CAR-T Cell Therapy in a Type of Blood Cancer Terminated


The manufacturer of the novel CAR-T cell therapy announced it terminated an early-phase trial investigating the treatment’s efficacy after there was a lack of benefit in patients with relapsed or refractory T-cell lymphoma, a type of blood cancer.

In a filing to the Securities and Exchange Commission (SEC), Legend Biotech announced it had informed the Food and Drug Administration (FDA) that it has terminated a phase 1 clinical trial investigating the efficacy of its novel CAR-T cell therapy LB1901 in adults with relapsed or refractory T-cell lymphoma, a rare type of blood cancer.

The manufacturer noted the decision was based on a lack of benefit associated with a similar CAR-T cell product with the same protein as LB1901 that was being analyzed in a different study. Legend Biotech also mentioned that the decision was made to cancel the trial to focus on other drug candidates it is developing.

In February of this year, the FDA placed a clinical hold on the trial after the manufacturer informed the agency that low CD4-positive T-cell counts were observed in the peripheral blood of the only patient to have been treated with the investigational therapy.

Previous findings published in the journal Leukemia & Lymphoma have shown that low CD4-positive T-cell counts have been associated with poor prognosis in patients with newly diagnosed multiple myeloma, which is another rare blood cancer that affects plasma cells.

The decision to terminate the trials comes several weeks after Legend reported that the FDA had lifted the hold on the trial.

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