Cellectis Gets FDA Approval for Third CAR-T Cell Trial

The FDA approved an investigational new drug application from Cellectis for a Phase 1 clinical trial of UCART22, its third gene-edited CAR-T cell candidate.

The therapy uses engineered cells from healthy donors rather than a patient’s own cells. The approval comes the month after the French company submitted the IND, which aims to treat adult patients with B-cell acute lymphoblastic leukemia.

Cellectis plans to initiate a Phase I clinical study later this year at the University of Texas MD Anderson Cancer Center.