A type of treatment which helps a cancer patient's immune system to fight blood cancer has been approved for use across the United Kingdom, having first been tested in two clinical trials coordinated by the CR UK & UCL Cancer Trials Centre.
Chimeric Antigen Receptor (CAR) T cell therapy is a form of immunotherapy that involves re-programming a patient’s white blood cells to recognise and attack cancer cells by targeting specific antigens such as CD19. Obe-cel (marketed as AUCATZYL®) is a CD19 CAR T cell therapy that has been designed for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (r/r B-ALL).
Obe-cel was originally developed by researchers at University College London (UCL). The CR UK & UCL Clinical Trials Centre (CTC) played an important role in evaluating the safety and preliminary efficacy of these CD19 CAR T cells through two Phase I clinical trials in adults and children with r/r B-ALL: ALLCAR19 (NCT02935257) and CARPALL (NCT02443831). Based on the promising data obtained in these UCL Phase I studies, Obe-cel was licensed by UCL spinout company Autolus Therapeutics, who then conducted the Phase II FELIX trial (NCT04404660) in adults with r/r B-ALL. The results of this pivotal trial led to U.S. Food and Drug Administration (FDA) marketing approval of Obe-cel in November 2024.
Following FDA approval, the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorised Obe-Cel as a therapy for adults with r/r B-ALL in April 2025. Obe-cel is currently undergoing assessment by the National Institute for Health and Care Excellence (NICE) to potentially make it a treatment option for r/r B-ALL patients on the NHS.
Image: Killer T cells surround a cancer cell (Alex Ritter, Jennifer Lippincott Schwartz and Gillian Griffiths, National Institutes of Health [CC BY 2.0])