Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosi… (NCT06230822) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)
China9 participantsStarted 2024-03-05
Plain-language summary
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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Gender unrestricted, aged between 40 and 80 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) ≥ 30% of the predicted value (adjusted for Hb), FVC/predicted ≥50%, and forced expiratory volume in one second (FEV1)/FVC ≥0.70;
. Newly diagnosed IPF patients (who may receive both the investigational drug and stable background antifibrotic therapy after enrollment), or IPF patients whose disease has been stable for at least 4 weeks at screening (a. no nintedanib and/or pirfenidone treatment for at least 4 weeks prior to screening; or b. receiving stable doses of nintedanib and/or pirfenidone for at least 4 weeks at screening, with planned continuation of this stable background therapy after entering the study; stable background therapy is defined as an individual patient being generally able to tolerate pirfenidone or nintedanib treatment).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of cell therapy-related adverse events (AEs) as assessed by CTCAE (V5.0)
Timeframe: 28 days
2
Maximum tolerated dose (MTD)
Timeframe: 28 days
Trial details
NCT IDNCT06230822
SponsorWuhan Optics Valley Vcanbiopharma Co., Ltd.
. Good compliance, able to understand and cooperate with pulmonary function test procedures, willing to participate voluntarily in the trial according to the protocol requirements, and understand and sign the informed consent form voluntarily.
Exclusion criteria
. 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;
. Previously received stem cell therapy or intolerant to cell therapy;
. Used non-biological drugs with cell proliferation inhibition or immunosuppressive/immunomodulatory effects during the 3 months prior to screening, such as Mycophenolate Mofetil, cyclophosphamide, tacrolimus, and JAK inhibitors, as well as other Chinese herbal medicines with immunomodulatory effects; Patients who have used low-dose corticosteroids (≤10 mg/day prednisone or equivalent dose of similar drugs) are allowed to be enrolled.
. Used biologics such as rituximab, TNF-α monoclonal antibodies, and IFN-γ monoclonal antibodies within the 6 months prior to screening;
. Used anticoagulant drugs, sildenafil, bosentan, macitentan, imatinib, and other drugs for treating IPF within the 4 weeks prior to screening;