Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)

NCT06230822 | Recruiting Phase 1

• 1 other identifier: VUM02-IPF-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

  28 days

• Maximum tolerated dose (MTD)

  Maximum tolerated dose (MTD) with multiple administrations.

  28 days

Secondary Outcomes (15)

• Incidence and severity of treatment- emergent adverse events

  24 weeks

• DLCO changes from baseline

  At baseline, 1, 4, 12 and 24 weeks

• FVC changes from baseline

  At baseline, 1, 4, 12 and 24 weeks

• Exercise capacity changes from baseline

  At baseline, 1, 4, 12 and 24 weeks

• St. George's Respiratory Questionnaire

  At baseline, 1, 4, 12 and 24 weeks

Study Arms (1)

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.

Drug: VUM02 Injection

Interventions

VUM02 Injection DRUG

VUM02 Injection will be administered intravenously every 3 days for a total of 3 doses.

Also known as: Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection

VUM02 Injection (hUCT-MSCs)+Conventional treatment

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to be eligible for this trial:
• 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;
• 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.

You may not qualify if:

• 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;
• Received unstable standard of care for IPF within the 3 months prior to screening;
• 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;
• 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;

Sponsors & Collaborators

• Wuhan Optics Valley Vcanbiopharma Co., Ltd.: lead

Study Sites (4)

Peking University Third Hospital

Beijing, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

The First People's Hospital of Kashi Prefecture, Xinjiang

Kashgar, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yuan Peng, Master

CONTACT

+86-27-87002897; pengyuan@vcanbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: VUM02 Injection (hUCT-MSCs)+Conventional treatment

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

CN (4)