Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large B-Cell Lymphoma (LBCL) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cell therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- ORR
- timeFrame
- day 30 post-infusion
- description
- 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 outcomes (2)
- measure
- event-free survival (EFS)
- timeFrame
- 5 years
- description
- 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
- measure
- Overall survival
- timeFrame
- 5 years
- description
- was calculated from the date of infusion to the date of death or last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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%
References
Publications (2)
- BACKGROUNDKatsin 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
- DERIVEDKonoplya 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