Background/Purpose: Epstein-Barr Virus (EBV) has been suggested as a potential environmental factor in systemic lupus erythematosus (SLE) onset and disease activity. Here, we report the results of a phase I/IIa clinical trial assessing the safety and the effects of anti-EBV CTL infusion in patients with non severe disease.

Methods: Nine patients meeting the American College of Rheumatology (ACR) criteria for SLE were included, and received a unique dose of 5.10⁶/kg autologous CTL. They were then prospectively followed for one year. Clinical activity scores and main biologic parameters such as anti-DNA, C3 and C4 levels, lymphocytes, IFN-α plasmatic levels count were recorded. Humoral anti EBV responses were monitored with ELISA assays for anti VCA, EBNA, EA/D antibodies. We also assessed frequency of EBV-specific T-cell with IFN-γ ELISPOT assays and plasmatic EBV viral loads. Adverse events were collected according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines.

Results: Average SLEDAI score at inclusion was 6,9, and three patients presented active EBV replication with positive PCR on blood (mean 3,17log ±0,65). Six patients were clinically stable during follow-up, one patient improved but with co-administration of other medications, two presented a flare requiring treatment intensification, but not immediately after injection.No critical adverse events related to the treatment were observed. We observed no significant changes in humoral and cellular anti-EBV responses after CTL infusion. Patients follow-up seems to show a relationship between IFN-α level and some serological parameters of the anti-EBV response, which needs to be confirmed in a larger group.

Conclusion: Although no serious adverse events were observed, and this treatment appears to be safe to use, none of the patients showed significant clinical improvement or changes in anti-EBV humoral or cellular responses. A larger demonstration of the relationship between IFN signature and EBV serological responses could justify pursuing this approach with adjustments in treatment.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/autologous-ebv-specific-cytotoxic-t-cells-in-systemic-lupus-erythematosus-an-innovative-phase-i-iia-clinical-trial/