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Idiopathic Pulmonary FibrosisPhase 1NCT05657184

Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001

A Phase 1 study testing REGEND001 in people with Idiopathic Pulmonary Fibrosis, run by Regend Therapeutics at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Idiopathic pulmonary fibrosis (IPF) is a condition where the lungs are damaged and scarred with unknown reason, making breathing becomes increasingly difficult.. REGEND001, made from airway basal cells with ability to regenerate lung tissue, is promising to IPF treatment. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
REGEND001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesChina
Study dates
19 Jul 2021to 9 Jun 2023
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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged between 50 to 75.
  • Diagnosis of IPF according to 2018 Idiopathic Pulmonary Fibrosis Diagnostic Guidelines.
  • Participants with 30%~79% of the predicted value in diffusing capacity for carbon monoxide (DLCO) and more than 50% of the predicted value in forced vital capacity (FVC) in pulmonary function tests within 3 months before screening.
  • Participants with typical HRCT images of IPF in the past 12 months.
  • Participants tolerant to bronchofiberscopy.
  • Participants fully informed with the purpose, method and possible discomfort of the trial, agreeing to participate in the trial and signing the informed consent voluntarily.
  • Participants with good adherence, willing to take medication and regular follow-up examinations as required by the protocol.
  • Participants able to understand and cooperate with the completion of pulmonary function tests.

Who cannot join

  • Participants who cannot tolerate cell therapy.
  • Pregnant or lactating women.
  • Participants with syphilis or any of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) positive antibody; of which stable HBV carriers after drug treatment and cured hepatitis C patients can be enrolled.
  • Participants with malignant tumors or a history of malignant tumors.
  • Participants with a history of long-term use of drugs known to cause pulmonary fibrosis, such as amiodarone before screening.
  • Participants with lung infections or other infections, including bacterial and viral infections, with requirement of intravenous medications before cell transplantation.
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  • Participants with a history of invasive or noninvasive mechanical ventilation within 4 weeks.
  • Participants with any of the following lung diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, pneumoconiosis, etc.; lung cancer, bronchiolitis obliterans or other active lung disease; pneumonia currently or in the past 4 weeks; pneumonectomy previously.
  • Requirement of oxygen therapy for more than 15 hours per day.
  • Suffering from serious diseases of other system.
  • leukopenia or agranulocytosis of any cause; blood creatinine > 2.5 times the upper limit of normal; alanine transaminase (ALT) and aspartate transaminase (AST) > 2.5 times the upper limit of normal in the laboratory tests.
  • Participants with a history of mental illness, suicide risk, epilepsy or other central nervous system disorders.
  • Severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG).
  • Participants with a history of abusing alcohol or illicit drug.
  • Participants allergic to cattle products.
  • Participants in other clinical trials in the past 3 months.
  • Participants with poor compliance and difficult to complete the trial.
  • Investigators, employees of research centers or family members of them (none of whom are suitable to participate in the trial to ensure the objectivity of the research);
  • Participants with a history of hospitalization owing to acute exacerbation of IPF or other respiratory diseases three or more times within the past year.
  • Participants who is taking or is goning to take nintedanib within a month.
  • Participants with other acquired or congenital immunodeficiency disorders, or with a history of organ transplantation or cell transplantation therapy.
  • Participants whose expected survival may be less than one year judged by the investigator.
  • Male participants of childbearing potential and female participants within childbearing age were reluctant to use effective contraception from the time of signing the informed consent to 6 months after cell therapy.
  • Participants assessed to be inappropriate in this clinical trial by investigator.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: An Open-label Clinical Study to Explore the Safety, Tolerability and Preliminary Efficacy of REGEND001 for Treatment of Idiopathic Pulmonary Fibrosis (IPF).

Idiopathic pulmonary fibrosis (IPF) is a condition where the lungs are damaged and scarred with unknown reason, making breathing becomes increasingly difficult.. REGEND001, made from airway basal cells with ability to regenerate lung tissue, is promising to IPF treatment. In this study, a single-armed clinical trial is ongoing to assess the safety and tolerability of REGEND001 in treatment of IPF. Different doses of REGEND001 is evaluated to establish a dose-response relationship and to suggest appropriate dose for subsequent clinical trials.

Being tested
REGEND001
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.

  • REGEND001Drug

    Transplantation of REGEND001 for dose escalation.

Study groups in NCT05657184
Study groupRoleWhat they receive
REGEND001ExperimentalTransplantation of autologous airway basal cells
Receives: Drug: REGEND001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of the cell therapy-related adverse events (AEs)

    Dose escalation is based on incidence of cell therapy-related AEs. Severity of cell therapy-related adverse events (AEs) is evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: Within 24 weeks after treatment

Secondary outcomes (16)

  1. Incidence of complication related to bronchoscopy

    REGEND001 is given to subjects by bronchoscopy. Thus, incidence of complication related to bronchoscopy is adapted to assess the safety of the products.

    Measured: Within 24 weeks after treatment

  2. Change in lung diffusing capacity for single-breath carbon monoxide (DLCO-sb) from baseline

    DLCO-sb is measured by the single-breath method. It is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.

    Measured: 4, 12 and 24 weeks after treatment

  3. Change in forced vital capacity (FVC) from baseline

    FVC indicates the volume of air that can forcibly be blown out after a full inspiration.

    Measured: 4, 12 and 24 weeks after treatment

  4. Change in the ratio of diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA) from baseline

    The DLCO test refers to the diffusing capacity for carbon monoxide in the lungs. It is a type of pulmonary function test that helps to assess how well gas is exchanged between the lungs and the bloodstream. Since DLCO is affected by the amount of inhaled gas and lung volume, the alveolar ventilation is considered to exclude the effect of lung volume on diffusion volume in evaluating diffusion function.

    Measured: 4, 12 and 24 weeks after treatment

  5. Change in 6-minute-walk test (6MWT) from baseline

    The 6MWT is a commonly used test for the objective assessment of functional exercise capacity by testing the distance patients can walk at the fastest speed within 6 minutes.

    Measured: 4, 12 and 24 weeks after treatment

  6. Change in St. George's Respiratory Questionnaire (SGRQ) scale from baseline

    Quality of life was assessed by St. George's Respiratory Questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.

    Measured: 4, 12 and 24 weeks after treatment

  7. Change in lung imags of high resolution computed tomography (HRCT) from baseline

    Lung images from HRCT will be analyzed to indicate the newly-derived pulmonary structure.

    Measured: 24 weeks after treatment

  8. Acute exacerbation of idiopathic pulmonary fibrosis (IPF)

    Frequency and severity of acute exacerbation of IPF will be evaluated.

    Measured: Within 24 weeks after treatment

  9. Change in blood routine from baseline

    Number of cases or participants with abnormal laboratory test results will be evaluated.

    Measured: Within 24 weeks after treatment.

  10. Change in urine routine from baseline

    Number of cases or participants with abnormal laboratory test results will be evaluated.

    Measured: Within 24 weeks after treatment.

  11. Change in blood biochemistry from baseline

    Number of cases or participants with abnormal laboratory test results will be evaluated.

    Measured: Within 24 weeks after treatment

  12. Change in 12-lead Electrocardiogram (ECG) from baseline

    Number of cases or participants with abnormal results wil be evaluated

    Measured: Within 24 weeks after treatment

  13. Change in carcinoembryonic antigen (CEA) from baseline

    CEA is a tumor marker used for early diagnosis of lung cancer.

    Measured: 12 and 24 weeks after treatment

  14. Change in neuron-specific enolase (NSE) from baseline

    NSE is a tumor marker significantly elevated in small cell lung cancer.

    Measured: 12 and 24 weeks after treatment

  15. Change in cytokeratin-19-fragment (CYFRA21-1) from baseline

    CYFRA21-1 is a tumor marker which has important value for the pathological classification and prognosis evaluation of lung cancer.

    Measured: 12 and 24 weeks after treatment

  16. Change in squamous cell carcinoma antigen (SCC) from baseline

    SCC is a specific marker for lung squamous cell carcinoma. Tumor markers are monitored to assess the safety.

    Measured: 12 and 24 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start19 Jul 2021
  3. Primary completion9 Jun 2023
  4. Study completion9 Jun 2023

Resources

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
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05657184
Sponsor's protocol ID
XHYX-IND-IPF-P1
Status last verified
Jul 2024
First submitted
15 Nov 2022
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing REGEND001 in people with Idiopathic Pulmonary Fibrosis, run by Regend Therapeutics at 3 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 8 inclusion and 24 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 the cell therapy-related adverse events (AEs) (time frame: Within 24 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05657184.

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 8 Jul 2024.

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