Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study
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.