Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse/Refractory B-cell Lymphoma
Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells
N.N. Alexandrov National Cancer Centre
76 participants
Jun 1, 2021
OBSERVATIONAL
Conditions
Summary
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 Criteria4
- 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 Criteria3
- pregnancy,
- active hepatitis B or C infection, HIV infection,
- naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%
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Interventions
The academic CAR-T cell product presented in this study encodes the anti-CD19 CAR construct with the single-chain variable fragment (scFv) of an anti-CD19 monoclonal antibody (FMC63) conjugated with the CD8 hinge region, CD4-1BB transmembrane (TM), co-stimulatory domain, and the CD3ζ pro-activator signaling domain along with a truncated form of the epidermal growth factor receptor (EGFRt) cell surface protein as a co-expression marker and a safety switch mechanism.
Locations(1)
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NCT07524816