Cellectis Gets FDA Nod For Initial-Stage Non-Hodgkin Lymphoma Study

The U.S. Food and Drug Administration (FDA) has announced clearance to Cellectis' CLLS 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 NatHaLi-01 study is a Phase 1/2a clinical trial designed to evaluate UCART20x22 in 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.

The Dose Finding portion of the study will evaluate UCART20x22 in a broad range of mature B-cell Non-Hodgkin lymphomas (NHL).

André Choulika, Chief Executive Officer, commented : "We are delighted that the FDA has cleared our IND application for UCART20x22. This is a very exciting product candidate, for two reasons: UCART20x22 will be our first dual allogeneic CAR T product candidate to enter clinical development, and dual targeting of CD20 and CD22, both validated targets in B-cell malignancies, has the potential to enhance tumor cell killing and increases the breadth of antigen targeting.”

The company outlined that UCART20x22 is its first allogeneic dual CAR T, targeting CD20 and CD22 simultaneously and first product candidate fully designed, developed and manufactured in-house.

Price Action : Cellectis shares are trading around 3 percent higher at $3.08 on Monday during after-hours session.