FDA gives Cellectis a green light to relaunch off-the-shelf CAR-T studies — with several strings attached
Two months after the FDA forced Cellectis $CLLS to hit the brakes on a pair of clinical trials for their off-the-shelf CAR-T UCART123, regulators have followed up with a green light to resume testing. But they’re adding some key safety measures to try to reduce any outstanding risks for patients in these high profile studies.
The trial halt came on the death of the first patient dosed with UCART123. Now investigators can begin again. But there are some extraordinary strings that are now attached:
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