Trial reportFrontiers in oncology2026
Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study.
Trial report in Frontiers in oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07524816 (Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells), which is not on this map. Not yet cited in PubMed.
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Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background/objective: Chimeric antigen receptor (CAR) T-cell therapy has been the standard of care for relapsed/refractory B-cell lymphomas (r/r BCLs) in recent years. However, high cost of commercial products limits their application in real-world clinical practice. The use of the so-called academic CAR-T cell products can reduce the cost and improve availability and affordability of this therapy option. The aim of the present clinical trial was to assess the efficacy and safety of academic CAR-T cells in r/r BCL patients. Materials and methods: From June 2021 to December 2025, this prospective clinical trial enrolled 76 r/r BCL patients treated at the N.N. Alexandrov National Cancer Centre of Belarus (Minsk, Republic of Belarus), ClinicalTrials.gov Identifier: NCT07524816. The patients were 23-68 years of age (median 47 years). The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR. Results: The median follow-up was 7.85 months for the entire cohort and 20.12 months for patients without events. Generally, complete response was achieved in 57.5% of patients. The 4-year event-free survival (EFS) rate was 46.2 ± 6.3%, and the 4-year overall survival (OS) rate was 67 ± 5.9%. Among patients with follicular lymphoma (FL), complete response was achieved in 83.3% patients. The 4-year EFS was 81.7 ± 9.6%. The safety profile was acceptable: cytokine release syndrome (CRS) was detected in 43.4% of patients (≥ grade 3 in 2.6%). No cases of grade 4 CRS were reported, and neurotoxicity (ICANS) was identified in 26.3% of patients (≥ grade 3 in 5.3%, grade 4 ICANS occurred in two patients - 2.6%). Conclusion: The anti-CD19 CAR T-cell product demonstrates good efficacy and acceptable toxicity in patients with r/r BCL. The use of such a product is the only available option for patients in countries where commercial products are not accessible. Clinical trial registration: https://clinicaltrials.gov/study/NCT07524816, identifier NCT07524816.
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