FDA gives Cellectis all clear after patient death halted off-the-shelf CAR-T trial

Four months after a patient death forced Cellectis to halt one of their off-the-shelf CAR-T trials, the FDA has given them the OK to start dosing patients again.

The Paris-based biotech said they changed the study’s protocol to accommodate the agency’s concerns, although they will still have to work with investigators to obtain local approval to restart the trial and start recruiting patients again. Prior its halt, the Phase I had sites in New York, New Jersey and Texas.