This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10\^7 cells per 10 mL per bag (5 x 10\^6 cells/mL). This study is a multiple-dose tolerability study following the "3+3" dose escalation principle and progressing from the low-dose group to the high-dose group sequentially. Three to six patients will be enrolled in each dose group and administered every 3 days for a total of 3 doses.
Gender unrestricted, aged between 40 and 75 years old (inclusive);
Diagnosed with IPF according to the 2022 Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline.
In the 3 months prior to administration, determined by the investigator to have stable disease, with diffusing capacity of the lung for carbon monoxide (DLCO) between 30% and 79% of the predicted value (adjusted for Hb), FVC/predicted ≥50%, and forced expiratory volume in one second (FEV1)/FVC ≥0.70;
Allowed to enroll are the patients who have been treated according to the current standard treatment plan for IPF and have maintained the treatment for at least 3 months;
Allergic to any ingredient of the product;
Suffering from interstitial lung diseases (ILD) other than IPF, including but not limited to: any other type of interstitial pneumonia; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs (such as amiodarone, bleomycin, or methotrexate); other types of occupational lung diseases; granulomatous lung diseases; systemic diseases including vasculitis, infectious diseases (i.e., tuberculosis), and connective tissue diseases, or a history of prior pulmonary resection;
During the screening period, having any of the following pulmonary diseases: asthma, pulmonary embolism, pneumothorax; lung cancer, obstructive bronchitis, or other active lung diseases; a known history of immune system diseases (such as thymic diseases, systemic lupus erythematosus); acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
Chest HRCT during the screening period shows emphysema area > fibrosis area;
Single group
VUM02 Injection
DrugVUM02 Injection will be administered intravenously every 3 days for a total of 3 doses.
Incidence and severity of cell therapy-related adverse events (AEs) as assessed by CTCAE (V5.0)
Incidence and severity of cell therapy-related adverse events (AEs) from the first dosing to 28 days after the last dosing
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) with multiple administrations.
Incidence and severity of treatment- emergent adverse events
Incidence and severity of cell treatment-emergent adverse events (AEs) as assessed by CTCAE v5.0 from the first dosing to 24 weeks after the last dosing.
DLCO changes from baseline
Changes from baseline in the percentage of diffusing capacity of the lung for carbon monoxide (DLCO) to the predicted value at 1 week, 4 weeks, 12 weeks, and 24 weeks after the last dosing.
FVC changes from baseline
Changes from baseline in the forced vital capacity (FVC) at 1 week, 4 weeks, 12 weeks, and 24 weeks after the last dosing.
Exercise capacity changes from baseline
Changes from baseline in the 6-minute walk test distance at 1 week, 4 weeks, 12 weeks, and 24 weeks after the last dosing.
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