A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases

Официальное название

A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the LVIVO-TaVec400 in the Treatment of Relapsed/Refractory Autoimmune Diseases

Обзор

This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.

Подробное описание

This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the LVIVO-TaVec400, an in vivo chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. The subject who meets the defined eligibility criteria will follow the sequential stages: screening, treatment (LVIVO-TaVec400 infusion) and follow-up (Up to 15 years).

Вмешательства

• Биопрепарат LVIVO-TaVec400 product
  Each subject will be given a single-dose LVIVO-TaVec400 via intravenous infusion.

Первичные конечные точки

• The incidence of Dose-limiting toxicity (DLT) [Срок оценки: 28 days after LVIVO-TaVec400 infusion (Day 1)]
• The incidence, severity of Adverse events (AEs) [Срок оценки: Minimum 13 weeks after LVIVO-TaVec400 infusion (Day 1)]
• The incidence, severity of Treatment-related Adverse event (TRAE) [Срок оценки: Maximum 15 years after LVIVO-TaVec400 infusion (Day 1)]
• Maximum concentration (Cmax) in peripheral blood [Срок оценки: Maximun 5 years after LVIVO-TaVec400 infusion (Day 1)]
• Time of maximum concentration (Tmax) in peripheral blood [Срок оценки: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)]
• Area under the concentration-time curve (AUC) in peripheral blood [Срок оценки: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)]
• Recommended Dose regimen finding [Срок оценки: Maximum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]

Вторичные конечные точки (5)

• Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline for r/r SLE subjects [Срок оценки: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
• Change in IgG4-RD Response Index (IgG4-RD RI) from baseline for r/r IgG4-RD subjects [Срок оценки: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
• Change in Expanded Disability Status Scale (EDSS) scores from baseline for PMS subjects. [Срок оценки: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
• Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores from baseline for r/r MG subjects. [Срок оценки: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]
• Change in Quantitative Myasthenia Gravis (QMG) scores from baseline for r/r MG subjects. [Срок оценки: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)]

Критерии участия

Критерии включения

• Subjects voluntarily participate in clinical studies.
• Age 18-65 years.
• Adequate organ function at screening.
• Clinical laboratory values meet criteria at screening visit.

r/r SLE:

• Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) OR 2012 Systemic lupus international collaborating clinics (SLICC) classification criteria for 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.

r/r IgG4-RD：

• Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD.
• Fulfill relapsed/refractory IgG4-RD conditions.
• Patients have active disease: IgG4-RD Response Index (RI) ≥2.

Progressive MS：

• Diagnosis of MS according to 2017 revised McDonald criteria.
• Progressive MS according to clinical course criteria revised in 2013.
• Presence of Cerebrospinal fluid (CSF) oligoclonal bands (OCBs) or elevated IgG Index at screening.

r/r MG：

• Diagnosis of MG.
• Myasthenia Gravis Foundation of America (MGFA) Class II-IV.
• Positive AChR-IgG or MuSK-IgG at screening.
• Fulfill refractory MG conditions.

Критерии исключения

• Active infections such as hepatitis and tuberculosis.
• Coexist other autoimmune or inflammatory diseases.
• Severe underlying diseases such as tumor, uncontrolled diabetes and severe heart diseases.
• Female subjects who are pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LVIVO-TaVec400 treatment.

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

Китай · 5 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Beijing Tiantan Hospital, Capital Medical University — Пекин
• Beijing Tiantan Hospital, Capital Medical University — Пекин
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань
• Shanxi Bethune Hospital — Taiyuan

Идентификаторы

NCT: NCT07583030 · LB2505-0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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