Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse/Refractory B-cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAR-T cell therapy.
- Who it may be relevant to
- Registry conditions: Large B-Cell Lymphoma (LBCL). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belarus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells
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.
Interventions
- Other CAR-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.
Primary outcome measures
- ORR [Time frame: day 30 post-infusion]
Secondary outcome measures (2)
- event-free survival (EFS) [Time frame: 5 years]
- Overall survival [Time frame: 5 years]
Eligibility criteria
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%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belarus · 1 center
- NN Alexandrov National Cancer Centre of Belarus — Lyasny
Publications
- Katsin M, Dormeshkin D, Meleshko A, Migas A, Dubovik S, Konoplya N. CAR-T Cell Therapy for Classical Hodgkin Lymphoma. Hemasphere. 2023 Nov 16;7(12):e971. doi: 10.1097/HS9.0000000000000971. eCollection 2023 Dec. PMID 38026793
- Konoplya NE, Doroshenko TM, Zharkova KY, Savich TV, Seviaryn IM, Bobrova NM, Beleevsky AA, Sarydze EK, Polyakov SL. Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study. Front Oncol. 2026 Jul 17;16:1862517. doi: 10.3389/fonc.2026.1862517. eCollection 2026. PMID 42539439
Identifiers
NCT: NCT07524816 · 001-0123