Idiopathic Pulmonary FibrosisPhase 1DEVIF-INCT06230822
Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)
A Phase 1 study testing VUM02 Injection in people with Idiopathic Pulmonary Fibrosis, run by Wuhan Optics Valley Vcanbiopharma Co., Ltd. at 4 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- VUM02 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesChina
- Study dates
- 5 Mar 2024to 1 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be eligible for this trial:
- 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).
- 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.
Who cannot join
- Patients meeting any of the following criteria are not eligible for this trial:
- 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;
Show all 22Show fewer
- 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;
- Participated in interventional clinical studies within the 3 months or within the half-life of 5 drugs (whichever is longer) before screening;
- Hospitalized 2 or more times in the past year due to acute exacerbation of IPF;
- Had a lung infection within the past month;
- Had a history of invasive or non-invasive mechanical ventilation, or currently require oxygen therapy (oxygen therapy time >15 h/d);
- Smoked within the past 3 months or cannot quit smoking during the trial;
- The expected survival period may be less than 1 year judged by investigator;
- Laboratory tests meet any of the following criteria: white blood cell count less than 3.5×109/L or neutrophils less than 1.5×109/L for any reason; hemoglobin (HGB) ≤90 g/L; fibrinogen (FIB) ≤0.5×LLN; alanine aminotransferase (ALT) >2×ULN, aspartate aminotransferase (AST) >2×ULN, total bilirubin (TBIL) >1.5×ULN, direct bilirubin (DBIL) >1.5×ULN, blood creatinine (Cr) >1.5×ULN;
- Evidence suggests that the subject currently has digestive system, urinary system, cardiovascular system, hematological system, nervous system, psychiatric, or metabolic diseases that may affect safety, such as severe kidney disease requiring blood dialysis or peritoneal dialysis; advanced hepatitis or cirrhosis; severe heart failure (NYHA Grade III and IV); poorly controlled hypertension (≥180/100 mmHg); severe pulmonary heart disease or pulmonary arterial hypertension considered by the investigators to affect the evaluation of the trial results;
- Have various malignant tumors or a history of malignant tumors;
- 12-lead electrocardiogram shows severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, and atrial flutter) or degree II and above atrioventricular block;
- Positive results in serological tests (HBsAg, HCV antibodies, HIV antibodies, syphilis spirochete antibodies), among which carriers of hepatitis B virus, stable patients with hepatitis B (DNA titer ≤2000 IU/mL or copy number <1000 copies/mL) after drug treatment, and cured patients with hepatitis C (negative HCV RNA) can be enrolled after being judged eligible by the investigator;
- Pregnant or lactating women, or those with a positive result in the screening period for beta-human chorionic gonadotropin (β-HCG) testing; or male subjects of childbearing potential and female subjects of childbearing age who are unable and unwilling to take effective non-drug contraceptive measures during the study and 6 months after the end of the study;
- Subjects deemed inappropriate for entry into this study by the investigator.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University Third Hospital
Beijing
West China Hospital of Sichuan University
Chengdu
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
The First People's Hospital of Kashi Prefecture, Xinjiang
Kashgar
About this study
Official title: A Phase I Open Label, Dose Escalation Study to Characterize the Safety, Tolerability, and Efficacy of VUM02 Injection in Subjects With Idiopathic Pulmonary Fibrosis
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.
Read the detailed description
This trial includes three predefined dose groups: low dose (5E7 cells/person/time), medium dose (1E8 cells/person/time), and high dose (2E8 cells/person/time) groups, for a multiple-dose tolerability study. Each dose group undergoes an initial safety and tolerability assessment with a single dose. After receiving the initial dose, subjects undergo safety evaluations on Day 3 (including symptom assessment, physical examination, vital signs monitoring, 12-lead electrocardiogram, hematology, urinalysis, blood biochemistry, and coagulation function tests). The decision to proceed with subsequent administrations for subjects who have received the initial dose is made through discussion between the investigator and the sponsor (and/or CRO medical staff) based on safety profiles.
This study follows the "3+3" dose escalation principle, progressing from the low-dose group to the high-dose group sequentially. The sample size may be adjusted based on the actual circumstances of the trial, with each subject receiving only one corresponding dose. During the study, a Safety Monitoring Committee (SMC) will be established, consisting of the investigators and representatives from the sponsor. The SMC will review the safety data generated during the study and make decisions regarding dose escalation, modification of escalation doses, alteration of dosing regimens, or study discontinuation. Only after all subjects in the preceding dose group have completed the dose-limiting toxicity (DLT) observation, and the SMC confirms that the dose escalation criteria are met, the enrollment for the next dose group will begin.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- VUM02 Injection
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VUM02 InjectionDrug
Also called Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection
VUM02 Injection will be administered intravenously every 3 days for a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| VUM02 Injection (hUCT-MSCs)+Conventional treatment | Experimental | 3 predefined dose groups: 5x10^7 cells/person/time, 1x10^8 cells/person/time and 2x10^8 cells/person/time, administered intravenously on D0, D3 and D6 for a total of 3 doses. Receives: Drug: VUM02 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) with multiple administrations.
Measured: 28 days
Secondary outcomes (15)
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.
Measured: 24 weeks
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.
Measured: At baseline, 1, 4, 12 and 24 weeks
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.
Measured: At baseline, 1, 4, 12 and 24 weeks
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.
Measured: At baseline, 1, 4, 12 and 24 weeks
St. George's Respiratory Questionnaire
Changes from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score at 1 week, 4 weeks, 12 weeks, and 24 weeks after the last dosing. The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
Measured: At baseline, 1, 4, 12 and 24 weeks
Symptoms of dyspnea
Changes from baseline in the dyspnea score at 1 week, 4 weeks, 12 weeks, and 24 weeks after the last dosing.
Measured: At baseline, 1, 4, 12 and 24 weeks
Symptoms of cough
Changes from baseline in the cough score at 1 week, 4 weeks, 12 weeks, and 24 weeks after the last dosing.
Measured: At baseline, 1, 4, 12 and 24 weeks
Tumor biomarkers
Changes from baseline in the lung tumor markers of CYFRA21-1, NSE, SCC, CEA and CA125 at 12 weeks and 24 weeks after the last dosing.
Measured: At baseline, 12 and 24 weeks
Chest imaging changes
Changes from baseline in the chest HRCT score at 12 weeks and 24 weeks after the last dosing.
Measured: At baseline, 12 and 24 weeks
Acute exacerbations of IPF
Frequency and severity of acute exacerbations of IPF from the first dosing to 24 weeks after the last dosing.
Measured: 24 weeks
T lymphocyte subpopulations
Changes from baseline in the percentages of CD3+, CD4+, CD8+, CD4+/CD8+ in peripheral blood at 1 week, 4 weeks, and 12 weeks after the last dosing.
Measured: At baseline, 1, 4 and 12 weeks
IgG and IgM levels
Changes from baseline in IgG levels in peripheral blood up to 12 weeks after the last dosing; Changes from baseline in IgM levels in peripheral blood up to 4 weeks after the last dosing.
Measured: At baseline, 12 or 4 weeks
Inflammatory cytokines
Changes from baseline in the cytokines of TNF-α, IFN-γ, TGF-β, IL-1, IL-2, IL-4, IL-5, IL-6 and CCL2 in peripheral blood at 1 week, 4 weeks, and 12 weeks after the last dosing.
Measured: At baseline, 1, 4 and 12 weeks
Serum complement levels
Changes from baseline in the serum complements of C3 and C4 in peripheral blood at 1 week, 4 weeks, and 12 weeks after the last dosing.
Measured: At baseline, 1, 4 and 12 weeks
Blood proteomics analysis
Changes from baseline in the blood proteomic analysis at 1 week, 4 weeks, 12 weeks, and 24 weeks after the last dosing.
Measured: At baseline, 1, 4, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start5 Mar 2024
- Primary completion13 Mar 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- VUM02 Injection (hUCT-MSCs)+Conventional treatment
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Optics Valley Vcanbiopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230822
- Sponsor's protocol ID
- VUM02-IPF-01
- Acronym
- DEVIF-I
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label, Dose Escalation Study to Characterize the Safety, Tolerability, and Efficacy of VUM02 Injection in Subjects With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06230822
- Acronym / sponsor ID
- DEVIF-I / VUM02-IPF-01
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wuhan Optics Valley Vcanbiopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial includes three predefined dose groups: low dose (5E7 cells/person/time), medium dose (1E8 cells/person/time), and high dose (2E8 cells/person/time) groups, for a multiple-dose tolerability study. Each dose group undergoes an initial safety and tolerability assessment with a single dose. After receiving the initial dose, subjects undergo safety evaluations on Day 3 (including symptom assessment, physical examination, vital signs monitoring, 12-lead electrocardiogram, hematology, urinalysis, blood biochemistry, and coagulation function tests). The decision to proceed with subsequent administrations for subjects who have received the initial dose is made through discussion between the investigator and the sponsor (and/or CRO medical staff) based on safety profiles.
This study follows the "3+3" dose escalation principle, progressing from the low-dose group to the high-dose group sequentially. The sample size may be adjusted based on the actual circumstances of the trial, with each subject receiving only one corresponding dose. During the study, a Safety Monitoring Committee (SMC) will be established, consisting of the investigators and representatives from the sponsor. The SMC will review the safety data generated during the study and make decisions regarding dose escalation, modification of escalation doses, alteration of dosing regimens, or study discontinuation. Only after all subjects in the preceding dose group have completed the dose-limiting toxicity (DLT) observation, and the SMC confirms that the dose escalation criteria are met, the enrollment for the next dose group will begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- VUM02 Injection (hUCT-MSCs)+Conventional treatment
| Arm | Type | Receives |
|---|---|---|
| VUM02 Injection (hUCT-MSCs)+Conventional treatment | Experimental | Drug: VUM02 Injection3 predefined dose groups: 5x10^7 cells/person/time, 1x10^8 cells/person/time and 2x10^8 cells/person/time, administered intravenously on D0, D3 and D6 for a total of 3 doses. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VUM02 InjectionAlso: Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells InjectionVUM02 Injection will be administered intravenously every 3 days for a total of 3 doses. | Drug | VUM02 Injection (hUCT-MSCs)+Conventional treatment |
Primary outcome
Incidence and severity of cell therapy-related adverse events (AEs) as assessed by CTCAE (V5.0)
Time frame: 28 days
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)
Time frame: 28 days
Maximum tolerated dose (MTD) with multiple administrations.
15 secondary outcomes
Incidence and severity of treatment- emergent adverse events
Time frame: 24 weeks
DLCO changes from baseline
Time frame: At baseline, 1, 4, 12 and 24 weeks
FVC changes from baseline
Time frame: At baseline, 1, 4, 12 and 24 weeks
Exercise capacity changes from baseline
Time frame: At baseline, 1, 4, 12 and 24 weeks
St. George's Respiratory Questionnaire
Time frame: At baseline, 1, 4, 12 and 24 weeks
Symptoms of dyspnea
Time frame: At baseline, 1, 4, 12 and 24 weeks
Symptoms of cough
Time frame: At baseline, 1, 4, 12 and 24 weeks
Tumor biomarkers
Time frame: At baseline, 12 and 24 weeks
Chest imaging changes
Time frame: At baseline, 12 and 24 weeks
Acute exacerbations of IPF
Time frame: 24 weeks
T lymphocyte subpopulations
Time frame: At baseline, 1, 4 and 12 weeks
IgG and IgM levels
Time frame: At baseline, 12 or 4 weeks
Inflammatory cytokines
Time frame: At baseline, 1, 4 and 12 weeks
Serum complement levels
Time frame: At baseline, 1, 4 and 12 weeks
Blood proteomics analysis
Time frame: At baseline, 1, 4, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VUM02 Injection in people with Idiopathic Pulmonary Fibrosis, run by Wuhan Optics Valley Vcanbiopharma Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of cell therapy-related adverse events (AEs) as assessed by CTCAE (V5.0) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.