Cellectis S.A. announced that the U.S. Food and Drug Administration (FDA) has cleared Cellectis' Investigational New Drug (IND) application to initiate a Phase 1/2a clinical trial of UCART20x22 for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL). The Company plans to begin enrolling patients in the NatHaLi-01 study in the second half of the year. UCART20x22 features TALEN®-mediated disruptions of the TRAC gene (that has been shown to reduce the risk of graft-versus-host disease) and of the CD52 gene (to allow using a CD52-directed monoclonal antibody in patients' preconditioning regimen and enhancing CAR T engraftment, expansion and persistence).

The Dose Finding portion of the study will evaluate UCART20x22 in a broad range of mature B-cell Non-Hodgkin lymphomas (NHL) which accounts for approximately 4% of all cancers. It is estimated that 81,560 new cases of NHL and 20,720 deaths related to the disease occurred in the US in 2021, and 122,979 new cases of NHL and 49,684 deaths related to NHL occurred in Europe in 2020.