Treatment of Progressive Multifocal Leukoencephalopathy with Third-Party Allogeneic BK Virus T Cells

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ID: 319667
2026
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Abstract
Abstract Background Progressive multifocal leukoencephalopathy (PML) is a fatal demyelinating disease caused by JC polyomavirus (JCV) that affects immunosuppressed individuals and has no approved therapy. Here we evaluate the safety and efficacy of third-party, off-the-shelf, partially HLA-matched BK virus-specific T cells (BK-VST) in patients with PML. Methods We conducted a single-center phase 2 study where 37 patients received most closely HLA-matched BK-VST at 2.0 x 105 T cells/kg, with additional infusions permitted for subjects who did not achieve a complete response. Twenty-three patients had an underlying diagnosis of hematologic malignancy. Each patient received a median of 2 doses (range, 1-12; IQR 2). Overall response (OR) was defined as virologic clearance with neurologic stabilization or improvement. Results During 12 months of follow-up, 21 patients (56.8%) achieved an OR, including 16 (43.2%) with a complete response. Responses were rapid (median 23 days) and durable, with no loss of response observed despite limited HLA matching. The 1-year overall survival was 61.1% (95% CI, 41.9-77.4). Patients achieving an OR after the first infusion had markedly improved 1-year survival compared with non-responders (93.3% vs 0%; p<0.001). Higher donor IL-2 and IFN-γ-producing T-cell frequencies and greater HLA matching correlated with clinical benefit. Conclusions These data demonstrate that third-party BK-VST infusions are safe and potentially effective, supporting a scalable immunotherapeutic approach for this otherwise fatal disease. (ClinicalTrials.gov NCT02479698).
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Authors Amanda Olson, Ye Li, David Marin, Peter F. Thall, Roland L. Bassett, Melissa Barnett, Rafet Başar, Pinaki P Banerjee, T Anne Kleiman, Merry Chen, Jennie Rexer, Max Wintermark, Jeanie Choi, Kim O. Learned, Indreshpal Kaur, Melihate Sylejmani, Glorette Abueg, Roy F. Chemaly, Victor E. Mulanovich, Rejeena Shrestha, Nadima Uprety, Karla Castro, May Daher, Isabel M. Galvan, Dominique Washington, Richard E Champlin, Elizabeth J. Shpall, Katayoun Rezvani
Journal Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Year 2026
DOI
10.1093/cid/ciag404
URL
https://doi.org/10.1093/cid/ciag404
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