NCT06825169

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nuwacell Biotechnologies Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Interstitial Lung Disease (ILD)

Interventions

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

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2028-09-01
• First posted: 2025-02-13
• Last updated: 2025-02-13