A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR101 in the Treatment of Subjects With Interstitial Lung Disease

Официальное название

A Phase I/II, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells (NCR101) Injection in the Treatment of Subjects With Interstitial Lung Disease

Обзор

The target of this trial is to evaluate the safety, tolerability and preliminary efficacy of NCR101 in the treatment of subjects with interstitial lung disease. The trial contains Single ascending dose（SAD） and Multiple ascending dose（MAD）. Subjects will receive at least 1 dose of NCR101.

Подробное описание

Interstitial lung disease (ILD) is a group of heterogeneous diseases, including idiopathic pulmonary fibrosis(IPF), hypersensitivity pneumonia, sarcoidosis, and connective tissue-associated interstitial lung disease (CTD-ILD), which is characterized by alveolar unit inflammation and/or fibrinization, leading to the destruction of lung structure and loss of function. In the absence of effective treatment, most ILD may develop diffuse pulmonary fibrosis, leading to structural destruction of lung tissue, diffusion dysfunction, and progressive respiratory failure and death. ILD causes a heavy disease and socio-economic burden, and has become a major public health problem. The target of treatment for interstitial lung disease depends on the type of disease and its clinical manifestations. At present, the existing drugs and treatments such as Pirfenidone and Nintedanib can only alleviate the symptoms of IPF or delay the progression of the disease, and the survival improvement is not obvious, and there is no treatment on the market can cure IPF, Patients with connective tissue have a high burden of lung complications, are prone to ILD complications, and the diagnosis and treatment of ILD are difficult for different CTDs. The evidence to guide the optimization of treatment is limited. Therefore, novel drugs with great therapeutic potential are urgently needed for ILD patients.

Вмешательства

• Биопрепарат NCR101 injection
  Subjects will receive one NCR101 injection in Single Ascending Dose（SAD）and receive 4 NCR101 injections in Multiple Ascending Dose(SAD).

Первичные конечные точки

• Adverse Event(AE) or Serious Adverse Event(SAE) [Срок оценки: 4 weeks after administration of SAD and multiple ascending dose (MAD)]

Вторичные конечные точки (7)

• Diffusion capacity of the lungs for carbon monoxide(DLCO) [Срок оценки: 4 weeks, 12 weeks, 24 weeks, 48 weeks]
• Forced vital capacity (FVC) [Срок оценки: 4 weeks, 12 weeks, 24 weeks, 48 weeks]
• Forced expiratory volume in 1 second (FEV1) [Срок оценки: 4 weeks, 12 weeks, 24 weeks, 48 weeks]
• 6-min walk test (6MWT) [Срок оценки: 4 weeks, 12 weeks, 24 weeks, 48 weeks]
• St George's Respiratory Questionnaire (SGRQ) [Срок оценки: 4 weeks, 12 weeks, 24 weeks, 48 weeks]
• Dyspnea index [Срок оценки: 4 weeks, 12 weeks, 24 weeks, 48 weeks]
• high-resolution computed tomography (HRCT) Score [Срок оценки: 24 weeks, 48 weeks]

Критерии участия

Критерии включения

• Age>18 years old (including threshold), gender not limited;
• Meets the diagnosis of interstitial lung disease;
• Screening for interstitial lung disease diagnosed by pulmonary imaging within the first 6 months;
• For patients undergoing glucocorticoid therapy at the time of screening: the background treatment remained stable during the study period;
• If the patient is undergoing anti-fibrotic therapy (pirfenidone or nintedanib) at the time of screening, they must have received a stable dose for at least 4 weeks at the time of screening and plan to continue receiving this background therapy steadily after entering this study;
• Patients of childbearing age (male and female) must agree to take effective non pharmacological contraceptive measures during the trial period and within 6 months after the last use of medication:
• Voluntarily sign an informed consent form and be able to cooperate in completing research related procedures and checks.

Критерии исключения

• Individuals with a history of severe allergies or allergies to the main active ingredients or excipients of the investigational drug;
• Individuals who have been hospitalized for three or more times due to acute exacerbation of ILD or other respiratory diseases within the previous year prior to screening;
• Individuals with a history of mechanical ventilation (invasive or non-invasive) within the past month prior to screening, or those currently requiring oxygen therapy (oxygen therapy duration>15 hours/day);
• Individuals who have contracted infectious pneumonia or require intravenous anti-infective treatment within the previous month; Previous history of tuberculosis
• Patients with other serious respiratory diseases, such as asthma, those with airway obstruction (FEV1/FVC<0.7 before using bronchodilators), and those with other clinically significant abnormalities in the lungs;
• Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone>240 mg/day) or irregularly use systemic corticosteroids;

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06825169 · NCR101-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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