The US Food and Drug Administration (FDA) has approved Cellectis’ investigational new drug (IND) application for allogeneic, chimeric antigen receptor (CAR) T-cell product candidate UCART22.
Unlike autologous therapies, which use a patient’s own engineered T-cells, this “off-the-shelf” investigational therapy uses engineered cells from a healthy donor for use in multiple patients.
The French biotech submitted the IND last month for UCART22, which is designed to treat adult patients with B-cell acute lymphoblastic leukemia (B-ALL).
“With this opportunity, Cellectis is well-positioned to further its work in the off-the-shelf gene-editing space, in the hope of helping patients to beat B-ALL in the near future,” said chief medical officer Stéphane Depil in a statement.
Cellectis expects to instigate a Phase I clinical study in the second half of the year at the University of Texas MD Anderson Cancer Center.