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NCT06825169

PHASE1/PHASE2

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

Sponsor: Nuwacell Biotechnologies Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-03-01

Completion Date

2028-09-01

Last Updated

2025-02-13

Healthy Volunteers

Conditions

Interstitial Lung Disease (ILD)

Interventions

BIOLOGICAL

NCR101 injection

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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;