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Идёт набор NCT07061938

Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease

Фаза I / Фаза II С лечением IgG4 Related Disease

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: ACE1831, Lymphodepleting chemotherapy.
Кому может быть актуально
Состояния в реестре: IgG4 Related Disease. Базовые параметры: 18 лет — 75 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
США, Япония
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

Phase 1b/2a Prospective, Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Immunoglobulin G4-Related Disease

Обзор

ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Immunoglobulin G4 Related Disease (IgG4-RD)

Подробное описание

ACE1831-201 study is an Open Label, Multicenter, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects with Immunoglobulin G4-Related Disease

Вмешательства

  • Препарат ACE1831
    ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
  • Препарат Lymphodepleting chemotherapy
    Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.

Первичные конечные точки

  • Safety and Tolerability of ACE1831 as Assessed by Adverse Events, Clinical Laboratory Tests, Physical Examinations, ECGs, and Vital Signs [Срок оценки: up to 72 weeks post last-ACE1831 dose]
Вторичные конечные точки (10)
  • To assess the efficacy of ACE1831 (primary efficacy) [Срок оценки: 24 weeks after last dose of ACE1831]
  • 3.1 To assess the efficacy of ACE1831 (secondary efficacy): Proportion of subjects who experience sustained complete remission [Срок оценки: up to 72 weeks post-last ACE1831 dose]
  • 3.2 To assess the efficacy of ACE1831 (secondary efficacy): Time to first flare [Срок оценки: up to 72 weeks post-last ACE1831 dose]
  • 3.3 To assess the efficacy of ACE1831 (secondary efficacy): Cumulative GC usage [Срок оценки: up to 72 weeks post-last ACE1831 dose]
  • 3.4 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SF-12 [Срок оценки: up to 72 weeks post-last ACE1831 dose]
  • 3.5 To assess the efficacy of ACE1831 (secondary efficacy): Changes in PGA [Срок оценки: up to 72 weeks post-last ACE1831 dose]
  • 3.6 To assess the efficacy of ACE1831 (secondary efficacy): Time to PGA = 0 [Срок оценки: up to 72 weeks post last-ACE1831 dose]
  • 3.7 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SGA [Срок оценки: up to 72 weeks post last-ACE1831 dose]
  • 3.8 To assess the efficacy of ACE1831 (secondary efficacy): Changes in SSI [Срок оценки: up to 72 weeks post last-ACE1831 dose]
  • 3.9 To assess the efficacy of ACE1831 (secondary efficacy): Changes in IgG4-RD RI [Срок оценки: up to 72 weeks post last-ACE1831 dose]

Критерии участия

Inclusion Criteria: To be eligible for this study, all of the following inclusion criteria must be met:

  • Signed Informed Consent
  • Male or female ≥ 18 to 75 years of age
  • Active IgG4-RD flare at screening with IgG4-RD Responder Index at least 2, confirmed by symptoms, labs, and/or imaging.
  • History of IgG4-RD involving at least 2 organs/sites, and current flare involves at least 1 organ/site (excluding lymph nodes) requiring treatment.
  • Elevated serum IgG4 above the upper limit of normal at screening.
  • Able to receive glucocorticoids for current flare and taper to 0 mg by Day -5.
  • Contraception agreement per protocol from screening through 24 weeks after last ACE1831 dose (no LDC) or 12 months after last LDC dose (with LDC).
  • For sites in China only: prior treatment failure to glucocorticoids and at least one immunosuppressive agent.

Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this trial.

  • Significant conditions that impair ability to receive study treatment or comply.
  • Predominant fibrosis in affected organs.
  • Active/latent infection that would interfere with therapy (including HBV, HCV, HIV, TB, syphilis) or significant recent infection per protocol.
  • Known immunodeficiency state.
  • NYHA class III/IV heart disease.
  • Severe allergy/hypersensitivity to monoclonal antibodies or relevant study agents.
  • Malignancy within 5 years (protocol exceptions apply).
  • Recent investigational agent exposure.
  • Recent B-cell depleting therapy (anti-CD20/anti-CD19) unless reconstitution per protocol.
  • Live/attenuated vaccine within 2 months.
  • Pregnant or breastfeeding.
  • Inadequate organ function/blood counts per protocol.

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 · 2 центра
  • Emory University — Atlanta
  • Massachusetts General Hospital — Boston
Япония · 1 центр
  • Kanazawa Medical University Hospital — Kahoku-gun

Идентификаторы

NCT: NCT07061938 · ACE1831-201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗