Interstitial Lung Disease (ILD)Phase 1/2NCT06825169
A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR101 in the Treatment of Subjects With Interstitial Lung Disease
A Phase 1/2 study testing NCR101 injection in people with Interstitial Lung Disease (ILD), run by Nuwacell Biotechnologies Co., Ltd..
Trial summary
The target of this trial is to evaluate the safety, tolerability and preliminary efficacy of NCR101 in the treatment of subjects with interstitial lung disease. The trial contains Single ascending dose（SAD） and Multiple ascending dose（MAD）. Subjects will receive at least 1 dose of NCR101. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- NCR101 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old (including threshold), gender not limited;
- Meets the diagnosis of interstitial lung disease;
- Screening for interstitial lung disease diagnosed by pulmonary imaging within the first 6 months;
- For patients undergoing glucocorticoid therapy at the time of screening: the background treatment remained stable during the study period;
- If the patient is undergoing anti-fibrotic therapy (pirfenidone or nintedanib) at the time of screening, they must have received a stable dose for at least 4 weeks at the time of screening and plan to continue receiving this background therapy steadily after entering this study;
- Patients of childbearing age (male and female) must agree to take effective non pharmacological contraceptive measures during the trial period and within 6 months after the last use of medication:
- Voluntarily sign an informed consent form and be able to cooperate in completing research related procedures and checks.
Who cannot join
- Individuals with a history of severe allergies or allergies to the main active ingredients or excipients of the investigational drug;
- Individuals who have been hospitalized for three or more times due to acute exacerbation of ILD or other respiratory diseases within the previous year prior to screening;
- Individuals with a history of mechanical ventilation (invasive or non-invasive) within the past month prior to screening, or those currently requiring oxygen therapy (oxygen therapy duration>15 hours/day);
- Individuals who have contracted infectious pneumonia or require intravenous anti-infective treatment within the previous month; Previous history of tuberculosis
- Patients with other serious respiratory diseases, such as asthma, those with airway obstruction (FEV1/FVC<0.7 before using bronchodilators), and those with other clinically significant abnormalities in the lungs;
- Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone>240 mg/day) or irregularly use systemic corticosteroids;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tao Ren, MD contact
About this study
Official title: A Phase I/II, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells (NCR101) Injection in the Treatment of Subjects With Interstitial Lung Disease
The target of this trial is to evaluate the safety, tolerability and preliminary efficacy of NCR101 in the treatment of subjects with interstitial lung disease. The trial contains Single ascending dose（SAD） and Multiple ascending dose（MAD）. Subjects will receive at least 1 dose of NCR101.
Read the detailed description
Interstitial lung disease (ILD) is a group of heterogeneous diseases, including idiopathic pulmonary fibrosis(IPF), hypersensitivity pneumonia, sarcoidosis, and connective tissue-associated interstitial lung disease (CTD-ILD), which is characterized by alveolar unit inflammation and/or fibrinization, leading to the destruction of lung structure and loss of function. In the absence of effective treatment, most ILD may develop diffuse pulmonary fibrosis, leading to structural destruction of lung tissue, diffusion dysfunction, and progressive respiratory failure and death. ILD causes a heavy disease and socio-economic burden, and has become a major public health problem. The target of treatment for interstitial lung disease depends on the type of disease and its clinical manifestations. At present, the existing drugs and treatments such as Pirfenidone and Nintedanib can only alleviate the symptoms of IPF or delay the progression of the disease, and the survival improvement is not obvious, and there is no treatment on the market can cure IPF, Patients with connective tissue have a high burden of lung complications, are prone to ILD complications, and the diagnosis and treatment of ILD are difficult for different CTDs. The evidence to guide the optimization of treatment is limited. Therefore, novel drugs with great therapeutic potential are urgently needed for ILD patients.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- NCR101 injection
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCR101 injectionBiological
Subjects will receive one NCR101 injection in Single Ascending Dose（SAD）and receive 4 NCR101 injections in Multiple Ascending Dose(SAD).
| Study group | Role | What they receive |
|---|---|---|
| NCR101 injection | Experimental | Cohort1:Low dose NCR101 injection; Cohort2:High dose NCR101 injection Receives: Biological: NCR101 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event(AE) or Serious Adverse Event(SAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Measured: 4 weeks after administration of SAD and multiple ascending dose (MAD)
Secondary outcomes (7)
Diffusion capacity of the lungs for carbon monoxide(DLCO)
Change from baseline in the result of DLCO
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks
Forced vital capacity (FVC)
Change from baseline in the result of FVC
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks
Forced expiratory volume in 1 second (FEV1)
Change from baseline in the result of FEV1
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks
6-min walk test (6MWT)
Change from baseline in the result of 6MWT
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks
St George's Respiratory Questionnaire (SGRQ)
Change from baseline in the result of SGRQ
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks
Dyspnea index
Change from baseline in the result of Dyspnea index
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks
high-resolution computed tomography (HRCT) Score
Change from baseline in the result of
Measured: 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Ren, MD, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825169
- Sponsor's protocol ID
- NCR101-1001
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells (NCR101) Injection in the Treatment of Subjects With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06825169
- Acronym / sponsor ID
- NCR101-1001
- Conditions
- Interstitial Lung Disease (ILD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Feb 2025 (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.
The target of this trial is to evaluate the safety, tolerability and preliminary efficacy of NCR101 in the treatment of subjects with interstitial lung disease. The trial contains Single ascending dose（SAD） and Multiple ascending dose（MAD）. Subjects will receive at least 1 dose of NCR101.
Detailed description
Interstitial lung disease (ILD) is a group of heterogeneous diseases, including idiopathic pulmonary fibrosis(IPF), hypersensitivity pneumonia, sarcoidosis, and connective tissue-associated interstitial lung disease (CTD-ILD), which is characterized by alveolar unit inflammation and/or fibrinization, leading to the destruction of lung structure and loss of function. In the absence of effective treatment, most ILD may develop diffuse pulmonary fibrosis, leading to structural destruction of lung tissue, diffusion dysfunction, and progressive respiratory failure and death. ILD causes a heavy disease and socio-economic burden, and has become a major public health problem. The target of treatment for interstitial lung disease depends on the type of disease and its clinical manifestations. At present, the existing drugs and treatments such as Pirfenidone and Nintedanib can only alleviate the symptoms of IPF or delay the progression of the disease, and the survival improvement is not obvious, and there is no treatment on the market can cure IPF, Patients with connective tissue have a high burden of lung complications, are prone to ILD complications, and the diagnosis and treatment of ILD are difficult for different CTDs. The evidence to guide the optimization of treatment is limited. Therefore, novel drugs with great therapeutic potential are urgently needed for ILD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCR101 injection | Experimental | Biological: NCR101 injectionCohort1:Low dose NCR101 injection; Cohort2:High dose NCR101 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age>18 years old (including threshold), gender not limited;
- Meets the diagnosis of interstitial lung disease;
- Screening for interstitial lung disease diagnosed by pulmonary imaging within the first 6 months;
- For patients undergoing glucocorticoid therapy at the time of screening: the background treatment remained stable during the study period;
- If the patient is undergoing anti-fibrotic therapy (pirfenidone or nintedanib) at the time of screening, they must have received a stable dose for at least 4 weeks at the time of screening and plan to continue receiving this background therapy steadily after entering this study;
Key exclusion criteria (6 listed)
- Individuals with a history of severe allergies or allergies to the main active ingredients or excipients of the investigational drug;
- Individuals who have been hospitalized for three or more times due to acute exacerbation of ILD or other respiratory diseases within the previous year prior to screening;
- Individuals with a history of mechanical ventilation (invasive or non-invasive) within the past month prior to screening, or those currently requiring oxygen therapy (oxygen therapy duration>15 hours/day);
- Individuals who have contracted infectious pneumonia or require intravenous anti-infective treatment within the previous month; Previous history of tuberculosis
- Patients with other serious respiratory diseases, such as asthma, those with airway obstruction (FEV1/FVC<0.7 before using bronchodilators), and those with other clinically significant abnormalities in the lungs;
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 |
|---|---|---|
| NCR101 injectionSubjects will receive one NCR101 injection in Single Ascending Dose（SAD）and receive 4 NCR101 injections in Multiple Ascending Dose(SAD). | Biological | NCR101 injection |
Primary outcome
Adverse Event(AE) or Serious Adverse Event(SAE)
Time frame: 4 weeks after administration of SAD and multiple ascending dose (MAD)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
7 secondary outcomes
Diffusion capacity of the lungs for carbon monoxide(DLCO)
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks
Forced vital capacity (FVC)
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks
Forced expiratory volume in 1 second (FEV1)
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks
6-min walk test (6MWT)
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks
St George's Respiratory Questionnaire (SGRQ)
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks
Dyspnea index
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks
high-resolution computed tomography (HRCT) Score
Time frame: 24 weeks, 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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.
Tao Ren, MD contact
Tao Ren, MD principal investigator
Shanghai 6th People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NCR101 injection in people with Interstitial Lung Disease (ILD), run by Nuwacell Biotechnologies Co., Ltd..
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Ren, M.Pharm (021-64369181, yqli@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event(AE) or Serious Adverse Event(SAE) (time frame: 4 weeks after administration of SAD and multiple ascending dose (MAD)). 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 13 Feb 2025.