Идёт набор NCT07095075

A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases

Ранняя фаза I С лечением Relapsed/Refractory Autoimmune Diseases

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-DKS1 NK cells.
Кому может быть актуально: Состояния в реестре: Relapsed/Refractory Autoimmune Diseases. 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 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases (r/r AID)

Обзор

This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-DKS1 in adult subjects with relapsed/refractory autoimmune diseases.

Подробное описание

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-DKS1, a chimeric antigen receptor (CAR) -NK cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LUCAR-DKS1 infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment LUCAR-DKS1 infusion) and follow-up.

Вмешательства

Биопрепарат LUCAR-DKS1 NK cells
Prior to the infusion of the LUCAR-DKS1 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: About 2 years after LUCAR-DKS1infusion (Day 1)]
Incidence of dose-limiting toxicity (DLT) [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]
Cmax [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]
Tmax [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]
AUC [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]
Recommended phase 2 dose regimen finding [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]

Вторичные конечные точки (5)

SLE disease activity: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [Срок оценки: About 2 years after LUCAR-DKS1infusion (Day 1)]
SSc disease activity :Modified rodnan skin score(mRSS) [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]
AAV disease activity： Birmingham vasculitis activity score (BVAS) [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]
IIM disease activity ：Manual muscle test-8 [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]
SjS disease activity: Sjögren's Tool for Assessing(STAR) [Срок оценки: About 2 years after LUCAR-DKS1 infusion (Day 1)]

Критерии участия

Inclusion Criteria:

Subjects voluntary agreement to provide written informed consent.
Aged 18 to 70 years, either sex.
Clinical laboratory values meet screening criteria.
Positive test for CD19 and/ or BCMA

SLE:

Meets at least 1 classification criteria≥6 months for SLE.
At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
Fulfill relapsed/refractory SLE conditions.

AAV:

Meets the 2022 ACR/EULAR classification criteria for AAV.
Positive test for anti-MPO or p-ANCA or anti-PR3 or anti-MPO antibodies at screening.
Fulfill relapsed/refractory AAV conditions.

SSc:

Meets the 2013 ACR/EULAR classification criteria for SSc.
At screening, mRSS is higher than 10.
Fulfill relapsed/refractory SSc conditions.

IIM:

Meets 2017 EULAR/ACR classification criteria for IIM.
Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
Fulfill relapsed/refractory IIM conditions. SjS：
Meets the 2016 ACR/EULAR diagnostic criteria for SjS.
Positive test for anti-SSA and/or anti-SSB antibodies at screening.
Fulfill relapsed/refractory SjS conditions.