Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
Treatment of Progressive Multifocal Leukoencephalopathy with Third-Party Allogeneic BK Virus T Cells.
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Olson Amanda, Li Ye, Marin David, Thall Peter F, Bassett Roland L, Barnett Melissa, Basar Rafet, Banerjee Pinaki P, Kleiman T Anne, Chen Merry, Rexer Jennie, Wintermark Max, Choi Jeanie, Learned Kim, Kaur Indreshpal, Sylejmani Melihate, Abueg Glorette, Chemaly Roy F, Mulanovich Victor, Shrestha Rejeena, Uprety Nadima, Castro Karla M, Daher May, Galvan Isabel M, Washington Dominique, Champlin Richard E, Shpall Elizabeth J, Rezvani Katayoun
Аннотация
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).
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).