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Author Notes:

Bilal Omer, Center for Cell and Gene Therapy, Feigin Tower, Suite 1640.16, 1102 Bates Ave, Houston, TX 77030; e-mail: baomer@txch.org.

I.T., H.E.H., and B.O. conceived and designed the study; S.N., K.S.L., C.M., G.S., R.A.K., S.G., A.P.G., and B.O. provided study materials or patients; I.T., A.W., M.W., R.D., and M.K. collected and assembled the data; S.N., K.S.L., C.M., G.S., R.A.K., M.W., S.G., and B.O. analyzed and interpreted the data; and all authors were involved in writing and final approval of the manuscript.

The authors thank all those who participated in this trial, clinicians, their staff, and patients.

They also thank Amy Reyna and Catherine Robertson for study coordination; Sara Richman and Deborah Lyon for Quality Assurance/Quality Control; Huimin Zhang and her team for cell processing; and Bridget Medina for regulatory assistance.

H.E.H. has equity interest in Viracyte, the sponsor of the study; and designed the clinical trial but had no role in data collection, interpretation of data, or decision to publish.

I.T. and S.G. are paid consultants for Viracyte.

S.G. receives research support from TESSA Therapeutics that is unrelated to this project; has patents and patent applications in the field of T-cell therapy and gene therapy for cancer; and is a member of the data safety monitoring board of Immatics US, Inc.

The remaining authors declare no competing financial interests.


Research Funding:

Funds for CMVST generation and conduct of the clinical trial were provided by Viracyte.

B.O. was supported by an educational National Institutes of Health K12 grant at Texas Children’s Hospital.

"mini" bank of only 8 donors supplies CMV-directed T cells to diverse recipients

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Journal Title:

Blood Advances


Volume 3, Number 17


, Pages 2571-2580

Type of Work:

Article | Final Publisher PDF


Cytomegalovirus (CMV) infections remain a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT), and standard antiviral therapies are associated with significant side effects and development of drug-resistant mutants. Adoptively transferred donor-derived CMV-specific T cells (CMVSTs) can provide an alternative treatment modality with few side effects but are not widely available due to their patient-specific nature. Here we report the establishment and use of a bank of CMVSTs derived from just 8 CMV-seropositive donors, with HLA types representing the diverse US population, as an "off-the-shelf" therapy to treat drug-refractory infections. To date, we have screened 29 patients for study participation and identified a suitable line, with ≥2 of 8 shared HLA antigens, for 28 (96.6%) patients with a median of 4 shared HLA antigens. Of these, 10 patients with persistent/refractory CMV infections or disease were eligible for treatment; a single infusion of cells produced 3 partial responses and 7 complete responses, for a cumulative response rate of 100% (95% confidence interval, 69.2-100) with no graft-versus-host disease, graft failure, or cytokine release syndrome. Potential wider use of the tested CMVSTs across transplant centers is made more feasible by our ability to produce sufficient material to generate cells for .2000 infusions from a single donor collection. Our data indicate that a "mini" bank of CMVSTs prepared from just 8 well-chosen third-party donors can supply the majority of patients with an appropriately matched line that produces safe and effective anti-CMV activity post-HSCT.

Copyright information:

© 2019 by The American Society of Hematology.

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