Overview
Chimeric antigen receptor (CAR) T-cell therapy has been the standard of care for relapsed/refractory large B-cell lymphomas (R/R LBCLs) since 2018. However, high cost of commercial products limits their application in real-world clinical practice. Academic approach to manufacturing CAR-T cell products can reduce the costs and improve availability and affordability of this therapy option. The aim of the present study is assess the efficacy and safety of the use of academic CAR-T cell products in r/r LBCL patients.This prospective observational study with r/r LBCL patients treated in the NN Alexandrov National Cancer Centre of Belarus. The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR.
Eligibility
Inclusion Criteria:
- age ≥18 years,
- relapsed or refractory LBCL,
- confirmed CD19 expression in tumor tissue,
- prior exposure to at least one line of anti-tumor therapy
Exclusion Criteria:
- pregnancy,
- active hepatitis B or C infection, HIV infection,
- naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%
