biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2023-23-2-148-161biopreparat-477Research ArticleСтатьиCовременные подходы к оценке качества, проведению доклинических и клинических исследований дендритно-клеточных вакцин в онкологииCurrent approaches to quality assessment, non-clinical and clinical studies of dendritic cell vaccines in oncologyhttps://orcid.org/0000-0002-7826-4861НехаеваТ. Л.NekhaevaT. L.

Нехаева Татьяна Леонидовна, канд. мед. наук

ул. Ленинградская, д. 68, пос. Песочный, Санкт-Петербург, 197758

Tatiana L. Nekhaeva, Cand. Sci. (Med.) 

68 Leningradskaya St., Pesochny, St Petersburg 197758

nehaevat151274@mail.ruhttps://orcid.org/0000-0002-0807-6953КамалетдиноваА. А.KamaletdinovaA. A.

Камалетдинова Айсылу Абраровна

Рахмановский пер., д. 3/25, стр. 1–4, Москва, ГСП-4, 127994

Aisylu A. Kamaletdinova

3/25 Rakhmanovsky Ln., bld. 1–4, Moscow 127994

KamaletdinovaAA@minzdrav.gov.ruhttps://orcid.org/0000-0003-1484-6587ЛутфуллинМ. Ф.LutfullinM. F.

Лутфуллин Марсель Фанисович

Рахмановский пер., д. 3/25, стр. 1–4, Москва, ГСП-4, 127994

Marsel F. Lutfullin

3/25 Rakhmanovsky Ln., bld. 1–4, Moscow 127994

LutfullinMF@minzdrav.gov.ruhttps://orcid.org/0000-0001-7965-6050ТабанскаяТ. В.TabanskayaT. V.

Табанская Татьяна Валерьевна

Петровский б-р, д. 8, стр. 2, Москва, 127051

Tatiana V. Tabanskaya

8/2 Petrovsky Blvd, Moscow 127051

TabanskayaTV@minzdrav.gov.ruФедеральное государственное бюджетное учреждение «Национальный медицинский исследовательский центр онкологии имени Н.Н. Петрова» Министерства здравоохранения Российской ФедерацииРоссияN.N. Petrov National Medical Research Center of OncologyRussian FederationМинистерство здравоохранения Российской ФедерацииРоссияMinistry of Health of the Russian FederationRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202328042023232От традиционных биологических к высокотехнологичным лекарственным препаратам: вопросы разработки и применения148161Copyright © Нехаева Т.Л., Камалетдинова А.А., Лутфуллин М.Ф., Табанская Т.В., 20232023Нехаева Т.Л., Камалетдинова А.А., Лутфуллин М.Ф., Табанская Т.В.Nekhaeva T.L., Kamaletdinova A.A., Lutfullin M.F., Tabanskaya T.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/477

На сегодняшний день применение персонализированных методов клеточной иммунотерапии злокачественных новообразований рассматривается как перспективный подход к лечению опухолей, а эффективность этих методов оценивается в контексте клинико-биологических характеристик опухоли и состояния иммунной системы конкретного пациента. Одним из вариантов иммунотерапии является разработка аутологичных противоопухолевых вакцин на основе дендритных клеток.

Цель работы — анализ современных методологических подходов к оценке качества, эффективности и безопасности противоопухолевых вакцин на основе дендритных клеток.

В обзоре приведено описание функциональной роли дендритных клеток в регуляции иммунного ответа, а также проведен анализ данных литературы, посвященных современным подходам получения дендритно-клеточных вакцин с заданными характеристиками, оценке качества, изучению противоопухолевой эффективности клеточного препарата, а также опыту проведения доклинических и клинических исследований. Освещены специфические аспекты международного опыта регистрации и клинического применения клеточных препаратов. В обзоре обсуждены методологические подходы к проведению доклинических исследований дендритно-клеточных вакцин, которые должны быть нацелены на получение сведений для выбора дозы, обоснования пути введения, режима применения клеточных препаратов, а также идентификации иммунологических маркеров, коррелирующих с клинической эффективностью. Рассмотрен международный опыт проведения клинических исследований дендритно-клеточных вакцин при различных злокачественных новообразованиях. Предложен перечень показателей качества клеточных препаратов на основе соматических клеток человека для их дальнейшего использования в клинической практике.

At present, personalised cellular immunotherapy is considered a promising approach to the treatment of malignant neoplasms. The effectiveness of these cellular immunotherapy methods is evaluated in the context of clinical and biological tumour characteristics and the state of the immune system of a particular patient. One of the immunotherapy options for cancer is the development of autologous dendritic cell vaccines.

The aim of this study was to analyse current methodological approaches to the evaluation of the quality, efficacy, and safety of dendritic cell cancer vaccines.

This review describes the functional role of dendritic cells in immune response regulation. The paper presents the results of literature analysis covering current approaches to obtaining dendritic cell vaccines with specific characteristics, quality assessment, studies of the anti-tumour efficacy of cell therapy products, and the experience of conducting non-clinical and clinical studies. The review highlights specific aspects of international experience in the registration and clinical use of cell therapy products. The authors discuss methodological approaches to non-clinical studies of dendritic cell vaccines, which should aim to obtain information to select the dose, route, and mode of administration and to identify immunological markers correlating to the clinical efficacy of cell therapy products. The paper covers international experience in conducting clinical trials of dendritic cell vaccines for various malignant neoplasms. The authors propose a list of quality attributes of human somatic cell-based medicinal products for further clinical use.

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The authors declare that there are no conflicts of interest present.