Third Party Viral Specific T-cells (VSTs)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Viral Specific VST Infusion.
- Кому может быть актуально
- Состояния в реестре: Viral Infection, Viral Reactivation, Infection in an Immunocompromised Host. Базовые параметры: от 2 Days · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
Обзор
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Подробное описание
Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.
Вмешательства
- Биопрепарат Viral Specific VST Infusion
VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following: * Blood adenovirus PCR ≥ 1,000 * Blood CMV PCR ≥ 500 * Blood EBV PCR ≥ 9,000 * Plasma BKV PCR \>1,000 * Plasma JC Virus PCR \> 1,000 * Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites * Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis * Evidence of
Первичные конечные точки
- Successful production of viral specific T-cells [Срок оценки: Within 30 days post culture initiation]
- Percentage of patients who do not have infusional toxicity [Срок оценки: Through 30 minutes post infusion]
- Incidence of GVHD associated with VST infusion [Срок оценки: Through 30 days after infusion]
Вторичные конечные точки (2)
- Presence of viral-specific T-cells [Срок оценки: At 30 days after infusion]
- Viral burden [Срок оценки: At 30 days after infusion]
Критерии участия
Критерии включения
- Immunocompromised patient with evidence of viral infection or reactivation
- Age >1 day
- Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
- Must be able to receive CTL infusion in Cincinnati
- Informed consent obtained by PI or sub-investigator either in person or by phone
Критерии исключения
- Active acute GVHD grades II-IV
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy requiring treatment with chemotherapy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
- Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 4 центра
- Akron Children's Hospital — Akron
- University of Cincinnati Medical Center — Cincinnati
- Cincinnati Children's Hospital Medical Center — Cincinnati
- The Ohio State University Wexner Medical Center - James Cancer Hospital — Columbus
Публикации
- Rubinstein JD, Pham G, Sridharan A, Khoury R, Wang YM, Hudda Z, Wilhelm J, Lichtenstein DA, Heyenbruch D, Cancelas JA, Davies SM, Lutzko C, Grimley MS. Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction. Blood Adv. 2025 Dec 23;9(24):6305-6313. doi: 10.1182/bloodadvances.2025017097. PMID 40991376
- Galletta TJ, Lane A, Lutzko C, Leemhuis T, Cancelas JA, Khoury R, Wang YM, Hanley PJ, Keller MD, Bollard CM, Davies SM, Grimley MS, Rubinstein JD. Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults. Transplant Cell Ther. 2023 May;2 PMID 36736781
- Rubinstein JD, Zhu X, Leemhuis T, Pham G, Ray L, Emberesh S, Jodele S, Thomas S, Cancelas JA, Bollard CM, Hanley PJ, Keller MD, Grimley O, Clark D, Clark T, Lindestam Arlehamn CS, Sette A, Davies SM, Nelson AS, Grimley MS, Lutzko C. Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted. Blood Adv. 2021 Sep 14;5(17):3309-332 PMID 34473237
- Nelson AS, Heyenbruch D, Rubinstein JD, Sabulski A, Jodele S, Thomas S, Lutzko C, Zhu X, Leemhuis T, Cancelas JA, Keller M, Bollard CM, Hanley PJ, Davies SM, Grimley MS. Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients. Blood Adv. 2020 Nov 24;4(22):5745-5754. doi: 10.1182/bloodadvances.2020003073. PMID 33216887
Идентификаторы
NCT: NCT02532452 · 2015-4184