Large B-Cell Lymphoma (LBCL)
Conditions
Keywords
academic CAR-T cell products, r/r large B-cell lymphomas, efficacy, safety
Brief 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.
Interventions
OTHERCAR-T cell therapy
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.
Sponsors
N.N. Alexandrov National Cancer Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | day 30 post-infusion | metabolic response evaluated by 2-deoxy-\[18F\]-fluoro-D-glucose positron emission tomography/computed tomography (FDG-PET/CT) performed on day 30 post-infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| event-free survival (EFS) | 5 years | was defined as the time from CAR T-cell infusion to disease progression, relapse, or death from any cause, whichever occurred first; patients alive without events were censored at the last follow-up |
| Overall survival | 5 years | was calculated from the date of infusion to the date of death or last follow-up. |
Countries
Belarus
Contacts
CONTACTNatalya Konoplya, PhD, MD, Professor
Outcome results
None listed