Идёт набор NCT07331272

A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

Фаза I С лечением Systemic Lupus Erythematosus (SLE) Idiopathic Inflammatory Myopathies(IIM)

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: LUCAR-G79D T cells.
Кому может быть актуально: Состояния в реестре: Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies(IIM). Базовые параметры: 18 лет — 70 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: Китай
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

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

Обзор

This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.

Подробное описание

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79D, a chimeric antigen receptor (CAR) -T cell therapy in subjects with r/r SLE and r/r IIM. Patients who meet the eligibility criteria will receive LUCAR-G79D infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79D infusion) and follow-up.

Вмешательства

Биопрепарат LUCAR-G79D T cells
Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Первичные конечные точки

Incidence, severity, and type of treatment-emergent adverse events (TEAEs) [Срок оценки: 2 years after LUCAR-G79D infusion (Day 1)]
Incidence of dose-limiting toxicity (DLT) [Срок оценки: 2 years after LUCAR-G79D infusion (Day 1)]
Maximum concentration (Cmax) in peripheral blood [Срок оценки: 2 years after LUCAR-G79D infusion (Day 1)]
Time of maximum concentration (Tmax) in peripheral blood [Срок оценки: 2 years after LUCAR-G79D infusion (Day 1)]
Area under the concentration-time curve (AUC) in peripheral blood [Срок оценки: 2 years after LUCAR-G79D infusion (Day 1)]
Recommended Dose regimen finding [Срок оценки: 2 years after LUCAR-G79D infusion (Day 1)]

Вторичные конечные точки (4)

Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r/r SLE subjects [Срок оценки: 52 weeks after LUCAR-G79D infusion (Day 1)]
Change in manual muscle testing (MMT-8) scores from baseline up to 52 weeks for r/r IIM subjects [Срок оценки: 52 weeks after LUCAR-G79D infusion (Day 1)]
Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects [Срок оценки: 52 weeks after LUCAR-G79D infusion (Day 1)]
Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects [Срок оценки: 52 weeks after LUCAR-G79D infusion (Day 1)]

Критерии участия

Критерии включения

Subjects voluntary agreement to provide written informed consent.
Aged 18 to 70 years, either sex.
Adequate organ function meet screening criteria.
Positive test for cluster of differentiation antigen 19 (CD19).

SLE:

Have been diagnosed of SLE at least 6 months before screening.
At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
Fulfill relapsed/refractory SLE conditions.

IIM:

Have been diagnosed of IIM before screening.
Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
Fulfill relapsed/refractory IIM conditions.