FDA grants fast track designation to novel combination CAR T-cell therapy, CLBR001 + SWI019, for B cell malignancies

On October 1, 2020, the U.S. Food and Drug Administration (FDA) granted fast track designation to CLBR001 + SWI019, a novel ‘switchable’ chimeric antigen receptor (CAR) T-cell therapy currently being evaluated for the treatment of patients with B cell malignancies, including non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).¹

CLBR001 + SWI019 is a combination therapy comprising an autologous CAR T-cell product (CLBR001) and an anti-CD19 antibody (SWI019), which acts as a molecular switch that controls the activity of the CAR T-cell. This approach has the potential to confer a significant safety advantage, and a first-in-human, phase I, dose-escalation study (NCT04450069) is currently recruiting patients diagnosed with relapsed or refractory B cell malignancies to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLBR001 + SWI019.

This novel combination immunotherapy may alleviate side effects which have hampered CAR T-cell therapy to date and, by employing a universal design, its future application could reach beyond B cell malignancies to other blood and solid tumor cancers.