CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

Официальное название

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

Обзор

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.

Подробное описание

In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.

Вмешательства

• Биопрепарат CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection
  Each subject receive CD19/BCMA Lupus Nephritis 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 (1)

• Urinary protein index [Срок оценки: Up to 24 hours after Treatment]

Критерии участия

Критерии включения

• 1\. Age ≥18 years old;
• 2\. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard.
• 3\. SLEDAI-2K ≥8 during screening
• 4\. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
• 5\. Expected survival >12 weeks;
• 6\. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);
• 7\. Volunteer to participate in this experiment and sign the 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\. Active infected persons who are not cured:
• 4\. Active hepatitis B or C virus infection;
• 5\. Patients who have taken more than 20mg/d of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);
• 6\. Have used any gene therapy products before;
• 7\. Insufficient amplification ability (<5 times) in response to CD3 / CD28 costimulation signals;
• 8\. ALT/AST>3 times the normal amount or bilirubin >2.0 mg/dl;
• 9\. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
• 10\. HIV-infected people;
• 11\. Any situation that the investigator believes may increase the risk to the subject or interfere with the test 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: NCT06785519 · TXB2024012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗