CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases

Официальное название

Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases

Обзор

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.

Подробное описание

In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases were accumulated, including rare and delayed complications.

Вмешательства

• Биопрепарат CD19-BAFF Targeted CAR T-cells
  Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Up to 28 years after Treatment]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 2 years after Treatment]

Вторичные конечные точки (3)

• Multiple Myeloma (MM), Overall response rate (ORR) [Срок оценки: Up to 2 years after Treatment]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years after Treatment]
• Duration of remission,DOR [Срок оценки: Up to 1 years after Treatment]

Критерии участия

Критерии включения

• 1\. Gender unlimited，18<Age;
• 2\. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission
• 3\. Estimated life expectancy of minimum of 12 weeks;
• 4\. The blood routine meets the following standards:

• Lymphocyte count>0.3×10e9/L;
• Neutrophils ≥0.5×10e9/L;
• Hemoglobin ≥60g/L;
• Platelet ≥30×10e9/L
• 5\. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
• 6.Those who voluntarily participated in this trial and provided informed consent;

Критерии исключения

• 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• 3.Pregnant or lactating women (the safety of this therapy for unborn children is still unknown)
• 4\. Patients with HIV infection
• 5\. Active infection of hepatitis B virus or hepatitis C virus;
• 6\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 7\. Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51 umol/L;
• 8\. Any unsuitable to participate in this trial judged by the investigator;
• 9\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
• 10\. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
• 11\. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)；
• 12\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

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

• The first affiliated hospital of medical college of zhejiang university — Ханчжоу

Идентификаторы

NCT: NCT06279923 · TXB2023023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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