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

General Information

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.
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.
Clinical trials phase Phases 1/2
Start date (estimated) 2025-03-01
End date (estimated) 2028-09-01
Clinical feature
Label interstitial lung disease
Link http://purl.obolibrary.org/obo/DOID_3082
Description A lung disease that is characterized by inflammation and altered lung interstitium compromising pulmonary function and often has_symptom shortness of breath, dyspnea, and/or cough.

Administrative Information

NCT number NCT06825169
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06825169
Other study identifiers
Name NCR101-1001
Source weblink https://clinicaltrials.gov/study/NCT06825169
Public contact
Email yqli@nuwacell.com
Public email yqli@nuwacell.com
First name Tao
Last name Ren
Phone + 86 021-64369181
City Shanghai
Country
China
Address freetext Shanghai 6th People's Hospital
Sponsors Nuwacell Biotechnologies Co., Ltd.

Cells

Which differentiated cell type is used
Label mesenchymal stem cell
Link http://purl.obolibrary.org/obo/CL_0000134
Description A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2.

Recruitment

Recruitment Status Not yet recruiting
Estimated number of participants 30