United States: Cellectis may resume its gene therapy trials



The FDA[1] has just lifted the suspension on clinical trials carried out by the French biotech company,  Cellectis, two months after halting proceedings following the death of a patient (see Cellectis forced to suspend gene therapy trials). These are phase 1 trials which  "aim to show how well patients tolerate UCART123, an anti-cancer drug based on genome editing". This treatment is mainly tested for use in the management of acute myeloid leukaemia and plasmacytoid dendritic cell leukaemia. Cellectis has modified the clinical trial protocols and, in particular, "the dose of its therapeutic product". The company has yet to satisfy the Institutional Review Boards before recruiting new patients.

 

[1] Food and Drug Administration.


Sources: 

La Tribune, Jean-Yves Paillé (7/11/2017)