Autologous Adoptive T-Cell Therapy for Recurrent or Drug-Resistant Cytomegalovirus Complications in Solid Organ Transplant Patients: A Single-Arm Open-Label Phase I Clinical Trial

Smith et al., Infectious Diseases Society of America (2016) - PMID: 29982441

Product(s) used in this publication:  Clinical Peptides & Pools



Opportunistic infections including cytomegalovirus (CMV) are a major cause of morbidity and mortality in solid organ transplant (SOT) recipients. The recurrent and protracted use of anti-viral drugs with eventual emergence of drug resistance represents a significant constraint to therapy. While adoptive T-cell therapy has been successfully used in haematopoietic stem cell transplant recipients, its extension to the SOT setting poses a considerable challenge because of the inhibitory effects of immunosuppressive drugs on the virus-specific T-cell response in vivo, and the perceived risk of graft rejection.


In this prospective study, 22 SOT recipients (13 renal, 8 lung and 1 heart) with recurrent or ganciclovir-resistant CMV infection were recruited and of these, 13 patients were treated with in vitro-expanded autologous CMV-specific T cells. These patients were monitored for safety, clinical symptoms and immune reconstitution.


Autologous CMV-specific T-cell manufacture was attempted for 21 patients, and was successful in 20 cases. The use of this adoptive immunotherapy was associated with no therapy-related serious adverse events. Eleven (84%) of the thirteen treated patients showed improvement in symptoms, including complete resolution or reduction in DNAemia, CMV-associated end organ disease and/or the cessation or reduced use of anti-viral drugs. Furthermore, many of these patients showed co-incident increased frequency of CMV-specific T cells in peripheral blood following completion of T-cell therapy.


The data presented here demonstrate for the first time the clinical safety of CMV-specific adoptive T-cell therapy and its potential therapeutic benefit for SOT patients with recurrent and/or drug-resistant CMV infection or disease.

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