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Идёт набор NCT06989541

Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy

— Наблюдательное Hypogammaglobulinemia, Acquired

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: Immune Globulin Intravenous (Human), 10%, Immune Globulin Subcutaneous (Human), 20% Solution.
Кому может быть актуально
Состояния в реестре: Hypogammaglobulinemia, Acquired. Базовые параметры: от 18 лет · 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
Канада
Следующий шаг
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Обзор

Chimeric antigen receptor (CAR) T cells are special immune cells taken from a patient and changed in a lab to help them find and attack cancer cells. These cells are designed to look for a marker called CD19, which is found on both cancer cells and healthy B cells (a type of white blood cell). Because of this, CAR T cells can also destroy healthy B cells. This can lead to a strong drop in B cells and cause a condition called hypogammaglobulinemia (HGG), which makes it harder for the body to fight infections. Serious infections are common in people treated with CAR T cells and are a major reason for death that is not caused by the return of cancer. To help prevent infections, patients with HGG often get immunoglobulin replacement therapy (IRT), which gives them the antibodies they need. This treatment can be given through a vein (IVIG) or under the skin (SCIG). The goal of this project is to study how often these patients get bacterial infections, how they feel about their quality of life and treatment, and what side effects they may have when treated with IVIG or SCIG after CAR T-cell therapy.

Подробное описание

Chimeric antigen receptor (CAR) T cells are patient-derived T cells engineered to express a fusion protein that directs them to target a tumor-associated antigen. The tumor-associated antigen CD19 is expressed on tumor cells in these conditions as well as on healthy cells of the B cell lineage. This results the "on-target off-tumor" effect of profound B cell depletion in these patients often with attendant hypogammaglobulinemia (HGG). Serious infections are common in this patient population and represent the main cause of non-relapse related mortality in CAR T cell treated patients.

Treatment of HGG with immunoglobulin replacement therapy (IRT) is a core component of infection prevention. Standard of care IRT can be administered intravenously (IVIG) or subcutaneously (SCIG). The proposed project will investigate frequency of bacterial infections, quality of life, treatment satisfaction, and adverse events in patients treated with CAR T-cell therapy who are treated with IVIG and SCIG.

Вмешательства

  • Биопрепарат Immune Globulin Intravenous (Human), 10%
    Intravenous immune globulin replacement
  • Биопрепарат Immune Globulin Subcutaneous (Human), 20% Solution
    Subcutaneous immune globulin replacement

Первичные конечные точки

  • Time normalized rate of infections grade 3 or greater [Срок оценки: 40 weeks]
Вторичные конечные точки (10)
  • Time normalized rate of validated infections [Срок оценки: 40 weeks]
  • Days on therapeutic antibiotics [Срок оценки: 40 weeks]
  • Days missed work/school/unable to perform normal daily activities due to infections [Срок оценки: 40 weeks]
  • Total number of days of hospitalizations due to infections [Срок оценки: 40 weeks]
  • Geometric mean of IgG serum trough concentration [Срок оценки: 40 weeks]
  • Mean TSQM9 [Срок оценки: 40 weeks]
  • IRT-related adverse events [Срок оценки: 40 weeks]
  • Hours of infusion clinic time required for IVIG administration [Срок оценки: 40 weeks]
  • Mean total grams of immunoglobulin administered [Срок оценки: 40 weeks]
  • Mean leukocyte counts at the last study visit [Срок оценки: 40 weeks]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Severe HGG defined as total IgG <4 g/L (after subtracting the IgG paraprotein fraction, if present)
  • Treated with CD19 targeted CAR T cell therapy in the past 6 months
  • Consent to receive plasma-derived productions
  • Ability to provide informed consent

Критерии исключения

  • Inability to comply with study procedures
  • Pregnancy or planning to conceive
  • Breastfeeding
  • Protein-losing conditions that may contribute to HGG (e.g., protein-losing enteropathy, nephrotic syndrome)
  • SCIG infusion in the prior 3 months.
  • History of allergy or severe reactions to immune globulin productions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • University of Alberta — Edmonton

Идентификаторы

NCT: NCT06989541 · HREBA.CC-24-0422

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗