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Open AccessArticle

Phase I Study of a B Cell-Based and Monocyte-Based Immunotherapeutic Vaccine, BVAC-C in Human Papillomavirus Type 16- or 18-Positive Recurrent Cervical Cancer

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Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea
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Department of Obstetrics and Gynecology, Chung-Ang University hospital, College of medicine, Chung-Ang University, Seoul 06974, Korea
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Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea
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Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea
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Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 06351, Korea
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Laboratory of Immunology, Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 06351, Korea
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Cellid, Inc., Seoul 06351, Korea
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(1), 147; https://doi.org/10.3390/jcm9010147 (registering DOI)
Received: 21 November 2019 / Revised: 26 December 2019 / Accepted: 3 January 2020 / Published: 5 January 2020
(This article belongs to the Section Obstetrics & Gynecology)
BVAC-C is a B cell-based and monocyte-based immuno-therapeutic vaccine transfected with a recombinant human papillomavirus (HPV) 16/18 E6/E7 gene and loaded with alpha-galactosyl ceramide, which is a natural killer T cell ligand. This phase I study sought to determine the tolerability and immunogenicity of BVAC-C in platinum-resistant recurrent cervical cancer patients. Patients with HPV 16-positive or 18-positive recurrent or persistent cervical cancer who had received at least one prior platinum-based combination chemotherapy were enrolled. BVAC-C was injected intravenously three times every four weeks, and dose escalation was planned in a three-patient cohort design at doses of 1 × 107, 4 × 107, or 1 × 108 cells/dose. Eleven patients were enrolled, and six (55%) patients had received two or more lines of platinum-based chemotherapy prior to enrollment. Treatment-related adverse events (TRAEs) were observed in 21 cycles. Most TRAEs were mild fever (n = 6.55%) or myalgia (n = 4.36%). No dose-limiting toxicities occurred. The overall response rate was 11% among nine patients evaluable, and the duration of response was 10 months. Five patients (56%) achieved a stable disease for 4.2–11 months as their best overall response. The median progression-free survival in all patients was 6.8 months (95% CI, 3.2 to infinite months), and the overall survival rate at 6 and 12 months was 89% (95% CI, 71 to 100%) and 65% (95% CI, 39 to 100%), respectively. BVAC-C induced the activation of natural killer T cells, natural killer cells, and HPV 16/18 E6/E7-specific T cells upon vaccination in all patients evaluated. BVAC-C was well tolerated and demonstrated a durable anti-tumor activity with an immune response in HPV 16-positive or 18-positive recurrent cervical carcinoma patients. A Phase 2 efficacy trial is currently underway. View Full-Text
Keywords: B cell; monocyte; therapeutic vaccine; HPV 16; HPV 18; cervical cancer B cell; monocyte; therapeutic vaccine; HPV 16; HPV 18; cervical cancer
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Choi, C.H.; Choi, H.J.; Lee, J.-W.; Kang, E.-S.; Cho, D.; Park, B.K.; Kim, Y.-M.; Kim, D.-Y.; Seo, H.; Park, M.; Kim, W.; Choi, K.-Y.; Oh, T.; Kang, C.-Y.; Kim, B.-G. Phase I Study of a B Cell-Based and Monocyte-Based Immunotherapeutic Vaccine, BVAC-C in Human Papillomavirus Type 16- or 18-Positive Recurrent Cervical Cancer. J. Clin. Med. 2020, 9, 147.

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