A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Официальное название

An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Обзор

This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy

Вмешательства

• Биопрепарат CD20/BCMA-directed CAR-T cells
  Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously

Первичные конечные точки

• Incidence of Adverse Events [Safety and Tolerability] [Срок оценки: Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion]
• The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]

Вторичные конечные точки (12)

• The proportion of subjects who achieved remission at 6 months (6M) [Срок оценки: Throughout the first 6 months follow up period completion (1.5 years)]
• The proportion of subjects who achieved remission during the main study period [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• The proportion of subjects who experienced relapse during the main study period [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• Time to response (TTR) [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• Progression-free survival (PFS) [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• Maximal plasma concentration (Cmax) [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• Time to reach the maximal plasma concentration (Tmax) [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• Duration in peripheral blood (Tlast) [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• Area under curve (AUC) [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• The clearance of peripheral blood B cell [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]
• The decline of serum immunoglobulin [Срок оценки: Throughout the first 24 months follow up period completion (3 years)]

Критерии участия

Критерии включения

• 18 to 70 years old at the time of signing the Informed Consent Form (ICF).
• Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months.
• Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ).
• Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.

Критерии исключения

• Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.
• Uncontrolled active infection.
• Live vaccine injection within 4 weeks prior to signing the ICF.
• Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
• Severe cardiovascular diseases within the past 6 months prior to screening.
• ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment.
• Inadequate washing time for previous treatment.
• Previously treated with CAR-T cell products or genetically modified T cell therapies.
• Pregnant or lactating women.
• Severe central nervous system diseases or pathological changes.
• Malignancy history within 5 years prior to signing the ICF.

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 · 1 центр

• Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong Universi — Шанхай

Идентификаторы

NCT: NCT06249438 · 1141-043(CAR-AID)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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