Clinical Study of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases

Summary

This study intends to conduct a prospective single-center open single-arm multi-dose escalation study on therapeutic immunological agent treatment in patients with Lymphoproliferative disease associated with EBV to observe the safety and efficacy.

Timeline

Start

2024-10

Primary completion

2025-12

Completion

2026-12

Publications

• Results Clerico M, Dogliotti I, Aroldi A, Consoli C, Giaccone L, Bruno B, Cavallo F. Post-Transplant Lymphoproliferative Disease (PTLD) after Allogeneic Hematopoietic Stem Cell Transplantation: Biology and Treatment Options. J Clin Med. 2022 Dec 19;11(24):7542. doi: 10.3390/jcm11247542.
• Results Hartlage AS, Liu T, Patton JT, Garman SL, Zhang X, Kurt H, Lozanski G, Lustberg ME, Caligiuri MA, Baiocchi RA. The Epstein-Barr Virus Lytic Protein BZLF1 as a Candidate Target Antigen for Vaccine Development. Cancer Immunol Res. 2015 Jul;3(7):787-94. doi: 10.1158/2326-6066.CIR-14-0242. Epub 2015 Mar 3.
• Results Savoldo B, Huls MH, Liu Z, Okamura T, Volk HD, Reinke P, Sabat R, Babel N, Jones JF, Webster-Cyriaque J, Gee AP, Brenner MK, Heslop HE, Rooney CM. Autologous Epstein-Barr virus (EBV)-specific cytotoxic T cells for the treatment of persistent active EBV infection. Blood. 2002 Dec 1;100(12):4059-66. doi: 10.1182/blood-2002-01-0039. Epub 2002 Aug 1.
• Results Bollard CM, Gottschalk S, Helen Huls M, Leen AM, Gee AP, Rooney CM. Good manufacturing practice-grade cytotoxic T lymphocytes specific for latent membrane proteins (LMP)-1 and LMP2 for patients with Epstein-Barr virus-associated lymphoma. Cytotherapy. 2011 May;13(5):518-22. doi: 10.3109/14653249.2011.561983. Epub 2011 Mar 1. No abstract available.
• Results Ma Y, Zhang P, Bao Y, Luo H, Wang J, Huang L, Zheng M. Outcomes of programmed death protein-1 inhibitors treatment of chronic active Epstein Barr virus infection: A single center retrospective analysis. Front Immunol. 2023 Mar 10;14:1093719. doi: 10.3389/fimmu.2023.1093719. eCollection 2023.
• Results Song Y, Wang J, Wang Y, Wang Z. Ruxolitinib in Patients With Chronic Active Epstein-Barr Virus Infection: A Retrospective, Single-Center Study. Front Pharmacol. 2021 Sep 6;12:710400. doi: 10.3389/fphar.2021.710400. eCollection 2021.
• Results Hui KF, Cheung AK, Choi CK, Yeung PL, Middeldorp JM, Lung ML, Tsao SW, Chiang AK. Inhibition of class I histone deacetylases by romidepsin potently induces Epstein-Barr virus lytic cycle and mediates enhanced cell death with ganciclovir. Int J Cancer. 2016 Jan 1;138(1):125-36. doi: 10.1002/ijc.29698. Epub 2015 Aug 11.
• Results Al-Mansour Z, Nelson BP, Evens AM. Post-transplant lymphoproliferative disease (PTLD): risk factors, diagnosis, and current treatment strategies. Curr Hematol Malig Rep. 2013 Sep;8(3):173-83. doi: 10.1007/s11899-013-0162-5.
• Results Kawa K, Sawada A, Sato M, Okamura T, Sakata N, Kondo O, Kimoto T, Yamada K, Tokimasa S, Yasui M, Inoue M. Excellent outcome of allogeneic hematopoietic SCT with reduced-intensity conditioning for the treatment of chronic active EBV infection. Bone Marrow Transplant. 2011 Jan;46(1):77-83. doi: 10.1038/bmt.2010.122. Epub 2010 May 24.
• Results Sawada A, Inoue M, Kawa K. How we treat chronic active Epstein-Barr virus infection. Int J Hematol. 2017 Apr;105(4):406-418. doi: 10.1007/s12185-017-2192-6. Epub 2017 Feb 16.
• Results Lu G, Xie ZD, Zhao SY, Ye LJ, Wu RH, Liu CY, Yang S, Jin YK, Shen KL. Clinical analysis and follow-up study of chronic active Epstein-Barr virus infection in 53 pediatric cases. Chin Med J (Engl). 2009 Feb 5;122(3):262-6.
• Results Kimura H, Morishima T, Kanegane H, Ohga S, Hoshino Y, Maeda A, Imai S, Okano M, Morio T, Yokota S, Tsuchiya S, Yachie A, Imashuku S, Kawa K, Wakiguchi H; Japanese Association for Research on Epstein-Barr Virus and Related Diseases. Prognostic factors for chronic active Epstein-Barr virus infection. J Infect Dis. 2003 Feb 15;187(4):527-33. doi: 10.1086/367988. Epub 2003 Jan 28.
• Results Yonese I, Sakashita C, Imadome KI, Kobayashi T, Yamamoto M, Sawada A, Ito Y, Fukuhara N, Hirose A, Takeda Y, Makita M, Endo T, Kimura SI, Ishimura M, Miura O, Ohga S, Kimura H, Fujiwara S, Arai A. Nationwide survey of systemic chronic active EBV infection in Japan in accordance with the new WHO classification. Blood Adv. 2020 Jul 14;4(13):2918-2926. doi: 10.1182/bloodadvances.2020001451.
• Results Kimura H, Hoshino Y, Kanegane H, Tsuge I, Okamura T, Kawa K, Morishima T. Clinical and virologic characteristics of chronic active Epstein-Barr virus infection. Blood. 2001 Jul 15;98(2):280-6. doi: 10.1182/blood.v98.2.280.

Drugs

Indications