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Идёт набор NCT06462365

Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)

Фаза I С лечением Hematologic Malignancy GvHD GVHD,Acute GVHD, Chronic

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: TRX103.
Кому может быть актуально
Состояния в реестре: Hematologic Malignancy, GvHD, GVHD,Acute, GVHD, Chronic. 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
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

Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)

Обзор

The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.

Вмешательства

  • Биопрепарат TRX103
    TRX103 infusion via central line.

Первичные конечные точки

  • Safety and tolerability of TRX103 cell infusion through incidence of Adverse events. [Срок оценки: Up to a year]
  • Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism. [Срок оценки: Up to day 42]
  • Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL). [Срок оценки: At 3-month, 6-month, and 1-year.]
Вторичные конечные точки (4)
  • Incidence of Grade II-IV acute GvHD (aGvHD). [Срок оценки: Day 0 to Day +100 day]
  • Incidence of Grade III-IV acute GvHD (aGvHD). [Срок оценки: Day 0 to Day +100 day]
  • Incidence and severity of chronic GvHD (cGvHD) [Срок оценки: Day +100 through Day +365]
  • Overall survival at Day +365. [Срок оценки: Up to a year]

Критерии участия

Критерии включения

  • Subjects with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
  • Males and Females Age ≥ 18 years.
  • Weight of ≥ 35 Kg.
  • Karnofsky performance status ≥ 70 %.
  • Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.
  • Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.
  • Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.
  • Have adequate organ function.
  • Subjects > 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score < 5.
  • Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.

Критерии исключения

  • Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.
  • Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
  • HIV positive.
  • Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
  • Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment and confirmed negative viral load by PCR.
  • Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning and/or have not recovered from treatment related toxicities.
  • Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.
  • Subjects that are pregnant, breast feeding or aim to become pregnant during the study period. (Subjects must agree to use a highly effective method of contraception).
  • Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 5 центров
  • City of Hope — Duarte
  • Dana-Farber Cancer Institute — Boston
  • University of Minnesota — Minneapolis
  • Memorial Sloan Kettering Cancer Center — New York
  • Fred Hutchinson Cancer Center — Seattle

Публикации

  • Uyeda MJ, Re A, Tang C, McLaughlin M, Humes D, Sexton S, Freeborn R, Villalba I, Nugent K, Adams J, Wei J, Breton M, Paliard X, Richter M, Roncarolo MG, Bjordahl R. Engineering allogeneic type 1 regulatory T cells: a scalable, off-the-shelf platform for restoring immune tolerance. Front Immunol. 2026 Jul 9;17:1848770. doi: 10.3389/fimmu.2026.1848770. eCollection 2026. PMID 42495646

Идентификаторы

NCT: NCT06462365 · TRX103-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗