Legend's early-stage CAR-T on FDA hold after single patient dosed

A phase 1 trial for Legend Biotech’s CAR-T therapy just got underway last year, and, now, the FDA has told the company to hit the brakes.

Legend announced a clinical hold for LB1901 in a brief press release Tuesday morning. Prior to receiving the hold notice from the agency, the company voluntarily paused the trial after the first patient was dosed and experienced low CD4+ T-cell counts.

The patient has not experienced any drug-related serious adverse events and is being monitored, according to Legend.

The FDA informed the company of the hold Friday, Feb. 11. Few details were disclosed beyond that the FDA will provide a more formal clinical hold letter by March 11.

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LB1901 is a CAR-T therapy that targets malignant CD4+ T cells in patients with relapsed or refractory T-cell lymphoma. So far, just the one patient has been dosed in that trial, which is expected to enroll up to 50 participants.

Legend touted the trial start at the J.P. Morgan Healthcare Conference in January, also noting that other early-stage programs are underway for the treatment in China.

Beyond this early-stage therapy, Legend has a major partnership with Johnson & Johnson for work on multiple myeloma CAR-T therapy cilta-cel. An approval for that treatment is expected this month.

Legend’s shares were down about 8% to $36.50 in premarket trading Tuesday morning.