CAR T cell therapy related cardiovascular outcomes
Research type
Research Study
Full title
Chimeric antigen receptor (CAR) T cell therapy related cardiovascular outcomes
IRAS ID
276079
Contact name
Derek Yellon
Contact email
Clinicaltrials.gov Identifier
Z6364106/2020/113, UCL Data Protection Registration Number
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood.
This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up. The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0301
Date of REC Opinion
15 Oct 2020
REC opinion
Further Information Favourable Opinion