CurePML: HPyV2-specific T cells to treat PML (Phase II Trial)

Allogeneic HPyV 2 specific T cell therapy in patients with progressive multifocal leukoencephalopathy

Sponsor:

Hannover Medical School
Carl-Neuberg-Strasse 1
30625 Hannover

Principal Coordinating Investigator:

Prof. Dr. med. Thomas Skripuletz
Clinic for Neurology
Hannover Medical School
Carl-Neuberg-Strasse 1
30625 Hannover

Trial protocol code: CurePML

Clinical Trials.gov: Study Details|NCT06990087|T-cell Therapy in Patients With PML|Clinical Trials.gov

Clinical Trials.gov: ID: NCT06990087

EudraCT number: n.a.

Publications:

Virus-Specific T Cells and Response to Checkpoint Inhibitors in Progressive Multifocal Leukoencephalopathy
Möhn N, Grote-Levi L, Bonifacius A, Tischer-Zimmermann S, Nay S, Jendretzky KF, Sassmann ML, Karacondi K, Zent M, Konen FF, Sühs KW, Meuth SG, Pawlitzki M, Warnke C, Ayzenberg I, Schneider R, Helmchen C, Brüggemann N, Klebe S, Hildner M, Grefkes C, Nitsch L, Hühnchen P, Böltz S, Alt L, Tuma-ni H, Kleinschnitz C, Pul R, Grauer O, Clifford D, Gnanapavan S, Wicklein R, Perpoint T, Beudel M, Del Bello A, Rauer S, Wiendl H, Jelcic I, Gasnault J, Cimini E, Antinori A, Pinnetti C, Pourcher V, Weiss N, Lambert N, Maecker-Kolhoff B, Höglinger GU, Zahraeifard S, Cortese I, Eiz-Vesper B, Martin-Blondel G, Skripuletz T; Immunotherapy for PML Study Group. JAMA Neurol. 2026 Jan 20:e255318. doi: 10.1001/jamaneurol.2025.5318.

Directly Isolated Allogeneic Virus-Specific T Cells in Progressive Multifocal Leukoencephalopathy
Möhn N, Grote-Levi L, Wattjes MP, Bonifacius A, Holzwart D, Hopfner F, Nay S, Tischer-Zimmermann S, Saßmann ML, Schwenkenbecher P, Sühs KW, Mahmoudi N, Warnke C, Zimmermann J, Hagin D, Goudeva L, Blasczyk R, Koch A, Maecker-Kolhoff B, Eiz-Vesper B, Höglinger G, Skripuletz T. JAMA Neurol. 2024 Oct 7;81(11):1187–98. doi: 10.1001/jamaneurol.2024.3324. Epub ahead of print. Erratum in: JAMA Neurol. 2025 Jun 1;82(6):630. doi: 10.1001/jamaneurol.2025.1019.

Combined treatment with allogeneic Epstein-Barr- and human polyomavirus 1 specific T-cells in progres-sive multifocal leukoencephalopathy and EBV infection: a case report.
Nay S, Möhn N, Grote-Levi L, Bonifacius A, Saßmann ML, Karacondi K, Tischer-Zimmermann S, Pöter H, Mahmoudi N, Wattjes MP, Maecker-Kolhoff B, Höglinger G, Eiz-Vesper B, Skripuletz T. Ther Adv Neurol Disord. 2024 May 28;17:17562864241253917. doi: 10.1177/17562864241253917.

Innovative therapeutic concepts of progressive multifocal leukoencephalopathy.
Möhn N, Grote-Levi L, Hopfner F, Eiz-Vesper B, Maecker-Kolhoff B, Warnke C, Sühs KW, Wattjes MP, Höglinger GU, Skripuletz T. J Neurol. 2022 May;269(5):2403-2413. doi: 10.1007/s00415-021-10952-5. Epub 2022 Jan 7.

Combined Treatment With Pembrolizumab and Allogenic BK Virus-Specific T Cells in Progressive Multifo-cal Leukoencephalopathy: A Case Report.
Wicklein R, Heidegger S, Verbeek M, Eiz-Vesper B, Maecker-Kolhoff B, Kirschke JS, Page A, Korn T, Hemmer B, Deschauer M. Neurol Neuroimmunol Neuroinflamm. 2021 Jul 20;8(5):e1042. doi: 10.1212/NXI.0000000000001042.

Allogeneic BK Virus-Specific T-Cell Treatment in 2 Patients With Progressive Multifocal Leukoencephalo-pathy.
Hopfner F, Möhn N, Eiz-Vesper B, Maecker-Kolhoff B, Gottlieb J, Blasczyk R, Mahmoudi N, Pars K, Adams O, Stangel M, Wattjes MP, Höglinger G, Skripuletz T. Neurol Neuroimmunol Neuroinflamm. 2021 May 17;8(4):e1020. doi: 10.1212/NXI.0000000000001020.

Antiviral T-Cell Frequencies in a Healthy Population: Reference Values for Evaluating Antiviral Immune Cell Profiles in Immunocompromised Patients.
Schulze Lammers FC, Bonifacius A, Tischer-Zimmermann S, Goudeva L, Martens J, Lepenies B, von Karpowitz M, Einecke G, Beutel G, Skripuletz T, Blasczyk R, Beier R, Maecker-Kolhoff B, Eiz-Vesper B. J Clin Immunol. 2022 Apr;42(3):546-558. doi: 10.1007/s10875-021-01205-1. Epub 2022 Jan 6.

Rapid generation of clinical-grade antiviral T cells: selection of suitable T-cell donors and GMP-compliant manufacturing of antiviral T cells.
Tischer S, Priesner C, Heuft HG, Goudeva L, Mende W, Barthold M, Kloeß S, Arseniev L, Aleksandrova K, Maecker-Kolhoff B, Blasczyk R, Koehl U, Eiz-Vesper B. J Transl Med. 2014 Dec 16;12:336. doi: 10.1186/s12967-014-0336-5.