Идёт набор NCT07123038

A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

— Наблюдательное Rheumatoid Arthritis (RA) Hidradenitis Suppurativa (HS)

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: Long Term Safety Monitoring Procedures.
Кому может быть актуально: Состояния в реестре: Rheumatoid Arthritis (RA), Hidradenitis Suppurativa (HS). Базовые параметры: 18 лет — 71 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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Обзор

To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.

Подробное описание

The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836. This is a Phase 4, multi-center long-term follow-up observational study to evaluate long-term safety in subjects who have received a gene-modified Treg therapeutic across Sonoma Biotherapeutics, Inc. clinical studies. The duration of the study is up to 15 years after dose of a Treg therapeutic in prior parent treatment protocols (SBT777101-01 and SBT777101-02) conducted by the Sponsor. Study visits will occur in accordance with the Schedule of Assessments.

Вмешательства

Другое Long Term Safety Monitoring Procedures
In accordance with the schedule of assessments, participants will complete the long term safety and health questionnaire and will undergo routine physical examinations. A review will be conducted on selected adverse events, medical history, and concomitant medication use. Collection of biospecimens (blood and tissue) will be taken as appropriate at scheduled visits to monitor for delayed adverse events related to prior cell therapy.

Первичные конечные точки

Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic [Срок оценки: 15 years]

Вторичные конечные точки (3)

Persistence of the SBT777101 gene-modified Treg therapeutic [Срок оценки: 15 years]
Incidence of replication competent lentivirus (RCL) [Срок оценки: 15 years]
Mortality in patients who received a gene-modified Treg therapeutic [Срок оценки: 15 years]

Критерии участия

Критерии включения

Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics, Inc. gene-modified Treg therapeutic in a prior parent treatment protocol.
Subject understands the purpose and risks of the study and is willing to provide written informed consent.
Subject is willing to comply with all study procedures for the follow-up period.