All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

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

Oct 2, 2020

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.

  1. Scripps Research. FDA grants fast track designation to Calibr’s ‘switchable’ CAR-T cell cancer therapy, CLBR001 + SWI019. Published Oct 1, 2020. Accessed Oct 2, 2020.