Chronic Obstructive Pulmonary DiseasePhase 2NCT05638776
Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy
A Phase 2 study testing REGEND001 cell therapy in people with Chronic Obstructive Pulmonary Disease, run by Regend Therapeutics at 8 sites in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- REGEND001 cell therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 8 sitesChina
- Study dates
- 6 Dec 2022to 9 Jul 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 40 to 75 at the time of signing informed consent.
- Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- The ratio of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)FEV1/FVC is < 70% after inhalation of bronchodilators.
- The diffusion function of carbon monoxide (DLCO) is ≥ 20% and < 80% of the predicted value at screening.
- Tolerated to pulmonary function tests.
- Tolerated to bronchoscopy
- Voluntary to sign the informed consent, coordinated to finish the trial-related procedures and tests, and capable of recording or stating the change of disease condition in a relatively complete manner.
Who cannot join
- Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
- Subjects with a positive result for any of the following tests at screening: treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody. But except the followings:
- Hepatitis B virus carriers (only HBsAg positive without any hepatitis symptom or sign, and all liver function tests present normal results or abnormal markers without clinical significance by the assessment of investigators);
- Cured hepatitis C patients (negative in HCV ribonucleic acid (RNA) test);
- Subject with assessed survival time of < 1 year by investigators at screening;
- Subject with malignant tumors or a history of malignant tumors at screening;
Show all 21Show fewer
- Subject with infections in lung or other sites, requiring intravenous drug treatment within a week prior to screening;
- Subject with more than 4 moderate-to-severe AECOPD, resulting in hospitalization within a year prior to screening;
- Subject with one or more pathogenetic or serologic findings of the novel coronavirus infection, or symptoms of suspected infection within 6 weeks prior to screening;
- Subject with a history of invasive or noninvasive mechanical ventilation within 4 weeks prior to screening;
- Subject who has taken prednisone tablets orally at a dose of ≥ 20 mg/day (or equivalent amount of other oral corticosteroids) within 4 weeks prior to screening;
- Subject with major lung diseases other than COPD by assessment of investigators at screening;
- Subject with severe systemic diseases other than lung within 6 months prior to screening and assessed to be inappropriate to participate in this trial by investigators;
- Subject with severe anemia or poorly controlled granulocyte deficiency, thrombocytopenia by assessment of investigators;
- Subject with abnormal coagulation and assessed to be negative for the safety of fiberoptic bronchoscopy operations at screening;
- Subject requiring long-term anticoagulation therapy of using antiplatelet coagulant therapeutic agents and disable to discontinue their medications 1 week prior to cell collection and cell infusion as assessed by investigators;
- Subject with a risk of suicide, a history of mental illness or a history of epilepsy at screening;
- Subject with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening;
- Subject participated in other clinical trials with interventions within 3 months prior to screening;
- Investigators, co-investigators, research coordinators, employees of research participants or research centers, or their family members;
- Any circumstance considered to probably increase the risk of patients or interfere with the clinical trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Shanghai East Hospital
Shanghai, Shanghai Municipality
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Multicenter, Randomized, Single-Blind, Placebo-Parallel-Controlled Research of REGEND001 Cell Therapy for Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND001 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, single-blind, placebo-parallel-controlled trial is performed to assess the efficacy and safety of REGEND001 cell therapy in treatment of chronic obstructive pulmonary disease with diffusion capacity defect.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- REGEND001 cell therapy, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGEND001 cell therapyDrug
Transplantation of the cell product
PlaceboDrug
Transplantation of Placebo
| Study group | Role | What they receive |
|---|---|---|
| REGEND001 cell therapy | Experimental | REGEND001 cell therapy |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsive rate (RR)
Ratio of subjects responsive to the treatment. Subject is considered to be responsive to the treatment as (1) the lung diffusing capacity for carbon monoxide (DLCO) improvement meets MCID (minimal clinically important difference) at 12 or/and 24 weeks after therapy; and (2) mean of DLCO at 12 and 24 weeks is no less than the baseline value. MCID of DLCO improvement is 1.1 ml/min/mmHg (0.37 mmol·min -1·kPa-1) or 11% for measured value compared to baseline .
Measured: 12 weeks after treatment, 24 weeks after treatment
Secondary outcomes (21)
Change of lung diffusing capacity for carbon monoxide (DLCO) from baseline
DLCO is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
Measured: Within 52 weeks after treatment
Change of the alveolar volume (VA) from baseline
Alveolar ventilation is the exchange of gas between the alveoli and the external environment. It is the process by which oxygen is brought into the lungs from the atmosphere and by which the carbon dioxide carried into the lungs in the mixed venous blood is expelled from the body.
Measured: Winthin 52 weeks after treatment
Change of images of lung by high resolution computed tomography (HR-CT) from baseline
HR-CT images of lung will be analyzed to indicate the change of pulmonary structure.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of forced vital capacity (FVC) from baseline
FVC is the full amount of air that can be exhaled with effort in a complete breath.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of forced expiratory volume in one second (FEV1) from baseline
FEV1 is the volume of breath exhaled with effort in one second.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) from baseline
The FEV1/FVC is a ratio that reflects the amount of air you can forcefully exhale from your lungs. It's measured by spirometry, a test used to evaluate lung function.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of the 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's 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 subject's alveolar ventilation (VA) is also considered when evaluating diffusion function to exclude the effect of lung volume on diffusion volume.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of 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: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of modified medical research council (mMRC) dyspnea scale from baseline
It is a questionnaire to evaluate how breathlessness impacts daily activities. According to the degree of activity impacted by shortness of breath, mMRC results are divided into 0-4 grades. Grade 0 means no breathlessness except on strenuous exercise; grade 1 means shortness of breath when hurrying on the level or walking up a slight hill; grade 2 means walking slower than people of same age on the level because of breathlessness or having to stop to catch breath when walking at their own pace on the level; grade 3 means stoping for breath after walking ∼100 m or after few minutes on the level ground; and grade 4 means too breathless to leave the house, or breathless when dressing or undressing.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of chronic obstructive pulmonary disease Assessment Test (CAT) from baseline
The CAT is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT scale includes a total of 8 items, 0~5 points for each item. The total score ranges 0~40 points. Score of 0-10 points indicates slight impact; Score of 11-20 points indicates medium impact: Score of 21-30 points indicates serious impact; Score of 31-40 points indicates very serious impact.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Annual frequency of exacerbations
Frequency of exacerbations all through the year. A lower frequency means improvement of disease.
Measured: 1 year after treatment
Symptoms, physical examination
Number of cases with abnormal physical examination findings.
Measured: Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
12-lead ECG
Number of cases with abnormal 12-lead Electrocardiogram (ECG).
Measured: 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Blood routine
Number of cases with abnormal laboratory test results.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Urine routine
Number of cases with abnormal laboratory test results.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Blood biochemistry
Number of cases with abnormal laboratory test results.
Measured: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Function of blood clotting
Number of cases with abnormal function of blood clotting.
Measured: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Carcinoembryonic antigen (CEA)
CEA is a tumor marker used for early diagnosis of lung cancer.
Measured: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Neuron-specific enolase (NSE)
NSE is a tumor marker significantly elevated in small cell lung cancer.
Measured: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Cytokeratin-19-fragment (CYFRA21-1)
CYFRA21-1 is a tumor marker which is valuable for the pathological classification and prognosis evaluation of lung cancer.
Measured: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Squamous cell carcinoma antigen (SCC)
SCC is a specific marker for lung squamous cell carcinoma.Tumor markers are monitored to assess the safety.
Measured: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start6 Dec 2022
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Southwest Hospital, China, Shanghai Zhongshan Hospital, China-Japan Friendship Hospital, Shanghai East Hospital, Regend Therapeutics XLotus (Jiangxi) Co, Ltd., The First Affiliated Hospital of Nanchang University, Xiangya Hospital of Central South University, The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638776
- Sponsor's protocol ID
- REGEND001-COPD-201
- Status last verified
- Jul 2025
- First submitted
- 2 Nov 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-Blind, Placebo-Parallel-Controlled Research of REGEND001 Cell Therapy for Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect
- ClinicalTrials.gov ID
- NCT05638776
- Acronym / sponsor ID
- REGEND001-COPD-201
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Regend TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Southwest Hospital, China, Shanghai Zhongshan Hospital, China-Japan Friendship Hospital, Shanghai East Hospital, Regend Therapeutics XLotus (Jiangxi) Co, Ltd., The First Affiliated Hospital of Nanchang University, Xiangya Hospital of Central South University, The First Affiliated Hospital of Soochow University
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 6 Dec 2022 (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.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND001 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, single-blind, placebo-parallel-controlled trial is performed to assess the efficacy and safety of REGEND001 cell therapy in treatment of chronic obstructive pulmonary disease with diffusion capacity defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGEND001 cell therapy | Experimental | –REGEND001 cell therapy |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 40 to 75 at the time of signing informed consent.
- Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- The ratio of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)FEV1/FVC is < 70% after inhalation of bronchodilators.
- The diffusion function of carbon monoxide (DLCO) is ≥ 20% and < 80% of the predicted value at screening.
- Tolerated to pulmonary function tests.
Key exclusion criteria (21 listed)
- Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
- Subjects with a positive result for any of the following tests at screening: treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody. But except the followings:
- Subject with assessed survival time of < 1 year by investigators at screening;
- Subject with malignant tumors or a history of malignant tumors at screening;
- Subject with infections in lung or other sites, requiring intravenous drug treatment within a week prior to screening;
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 |
|---|---|---|
| REGEND001 cell therapyTransplantation of the cell product | Drug | – |
| PlaceboTransplantation of Placebo | Drug | Placebo |
Primary outcome
Responsive rate (RR)
Time frame: 12 weeks after treatment, 24 weeks after treatment
Ratio of subjects responsive to the treatment. Subject is considered to be responsive to the treatment as (1) the lung diffusing capacity for carbon monoxide (DLCO) improvement meets MCID (minimal clinically important difference) at 12 or/and 24 weeks after therapy; and (2) mean of DLCO at 12 and 24 weeks is no less than the baseline value. MCID of DLCO improvement is 1.1 ml/min/mmHg (0.37 mmol·min -1·kPa-1) or 11% for measured value compared to baseline .
21 secondary outcomes
Change of lung diffusing capacity for carbon monoxide (DLCO) from baseline
Time frame: Within 52 weeks after treatment
Change of the alveolar volume (VA) from baseline
Time frame: Winthin 52 weeks after treatment
Change of images of lung by high resolution computed tomography (HR-CT) from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of forced vital capacity (FVC) from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of forced expiratory volume in one second (FEV1) from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of the diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA) from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of 6-minute-walk test (6MWT) from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of modified medical research council (mMRC) dyspnea scale from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of chronic obstructive pulmonary disease Assessment Test (CAT) from baseline
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Annual frequency of exacerbations
Time frame: 1 year after treatment
Symptoms, physical examination
Time frame: Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
12-lead ECG
Time frame: 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Blood routine
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Urine routine
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Blood biochemistry
Time frame: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Function of blood clotting
Time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Carcinoembryonic antigen (CEA)
Time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Neuron-specific enolase (NSE)
Time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Cytokeratin-19-fragment (CYFRA21-1)
Time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Squamous cell carcinoma antigen (SCC)
Time frame: Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REGEND001 cell therapy in people with Chronic Obstructive Pulmonary Disease, run by Regend Therapeutics at 8 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 7 inclusion and 21 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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 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?
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?
Responsive rate (RR) (time frame: 12 weeks after treatment, 24 weeks after treatment). 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 28 Sep 2026.