OBJECTIVE

To assess the effectiveness and safety of therapy with locally produced anti-CD19 CAR-T cells carrying a chimeric antigen receptor (CAR-T cell therapy) in patients with relapsed/refractory forms of B-cell lymphomas.

MATERIAL AND METHODS

CAR-T cell therapy was administered to 11 patients with prior lymphodepleting chemotherapy. The therapy’s effectiveness was evaluated using positron emission tomography combined with computed tomography. The anti-CD19 chimeric receptor of the second generation was constructed from anti-CD19-scFv antibody fragment, CD28 transmembrane domain, signaling domains of proteins 4-1BB and CD3z, and transduced into T-lymphocytes using a lentiviral vector S4. The cellular product was obtained by separating and processing CD4 and CD8 lymphocytes in the presence of interleukin-7 and interleukin-15.

RESULTS

After CAR-T cell infusion, expansion of CAR-T cells was observed in all 11 patients, accompanied by B-cell aplasia. The median follow-up period was 6.2 months (range 2—21 months). The objective response rate was 100% (10/10), with complete remission achieved in 9 patients and partial remission in 1. One patient died from complications before achieving a clinical response. Overall one-year survival was 77.9%. Grade III cytokine release syndrome occurred in 9.1%, grade I in 18.2%, grade III neurotoxicity in 9.1%, with no cases of grade II or IV neurotoxicity.

CONCLUSION

The study demonstrated the effectiveness and safety of locally produced CAR-T cells for treating patients with refractory B-cell lymphomas.