Chronic Obstructive Pulmonary DiseasePhase 2NCT07418736
A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study testing CM326 dose 1 and CM326 dose 2 in people with Chronic Obstructive Pulmonary Disease, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- CM326 dose 1 and CM326 dose 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 10 Oct 2027
- Phase
- Phase 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the study and voluntarily sign the informed consent form.
- Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.
- weight ≥40 kg.
- Diagnosed with COPD for at least 12 months.
- Post-bronchodilator FEV1/FVC ratio <0.70 and post-bronchodilator FEV1 % predicted ≥20% and <80%.
- Background therapy for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening.
Show all 11Show fewer
- Exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening.
- COPD assessment test (CAT) Total Score ≥10.
- Blood eosinophils ≥0.15×10^9 /L at screening.
- Current smoking or a history of smoking ≥ 10 pack-years, or exposure to biomass smoke (including but not limited to biomass fuel, secondhand smoke, and the like) for ≥ 10 years.
- Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.
Who cannot join
- A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）
- Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator. Or other conditions that could lead to elevated eosinophils.
- The presence of any severe and/or uncontrolled medical condition that in the judgment of the investigator would affect the evaluation of the drug, including but not limited to: severe neurological disease (eg, epilepsy, dementia, etc), history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation（male >450 msec, female >470 msec）, or persistent arrhythmia.
- History of malignancy.
- Previous history of known or suspected immunosuppression; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment.
- Prior autoimmune disease or inflammatory treatment with biologic agents/systemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever is longer) prior to informed consent.
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- Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the investigator or with evidence of right cardiac failure.
- Myocardial infarction, unstable angina, or stroke occurring within 6 months prior to signing the informed consent form (ICF).
- Parasitic infection diagnosed within 24 weeks prior to signing the informed consent form (ICF), which has not received standard treatment or is refractory to standard treatment.
- Acute moderate or severe exacerbation of COPD from 4 weeks before signing consent to the time of randomization.
- Acute infection requiring systemic anti-infective therapy from 4 weeks before signing consent to the time of randomization.
- Major surgery within 8 weeks prior to consent or planned surgery requiring general anesthesia or hospitalization for > 1 day during the study period.
- History of or planned pneumonectomy or lung volume reduction surgery for COPD 12 months prior to screening.
- As judged by the investigator, long-term daily oxygen therapy for more than 15 hours per day due to medical necessity, or concurrent hypercapnia requiring the use of bilevel positive airway pressure (BiPAP) non-invasive ventilation.
- Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who start rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program could be included).
- Patients who are treated with systemic corticosteroids (topical, ophthalmic, or intranasal corticosteroids are excluded) from 4 weeks before signing the informed consent to the date of randomization. Except for short-term (≤7 days) use of systemic glucocorticoids to prevent or treat non-autoimmune allergic diseases.
- Use of macrolide antibiotics (eg, azithromycin) unless stable >3 months prior to screening visit and maintain the treatment during the planned study period.
- Treatment with a PDE-4 inhibitor (roflumilast) (unless on stable treatment for ≥ 3 months with a plan to maintain stable treatment throughout the study period).。
- Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days before consent or any other biologic therapy (including other anti-IL4R mAb, anti-IL5 mAb, anti-IL5R mAb, anti TSLP mAb, anti-IL33 mAb, anti-ST2 mAb) within 3 months or 5 half-lives before signing consent, whichever is longer.
- Have been enrolled in a clinical trial of any drug or medical device within 3 months before signing informed consent, or are within the follow-up period of a clinical study or the five half-lives of the trial drug (whichever is longer) before signing informed consent.
- Received immune globulin or blood products within 30 days before informed consent.
- Receipt of traditional Chinese medicines (TCMs), ethnic medicines, or natural medicines approved by the National Medical Products Administration (NMPA) for the indication of COPD treatment within 4 weeks prior to randomization.
- Receipt of live or attenuated vaccine within 3 months before consent signing or during the planned study period.
- Non-negative HIV serological test result at screening, or Treponema pallidum infection requiring treatment.
- Subjects infected with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) must meet the following laboratory criteria during the screening period: a. HBsAg positive b. HBsAg negative , HBcAb positive, HBV DNA exceed the lower limit of quantitation (LLOQ) or 1000 copies/mL c. HCV antibody positive, HCV RNA exceed the LLOQ.
- At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN), or serum creatinine (Cr) > 1.5 × ULN or serum creatinine > 1.5 × ULN.
- Females with a positive pregnancy test, pregnant females, or lactating females.
- Allergy or intolerance to components of CM326 injection or placebo or history of severe drug allergy or anaphylactic shock.
- History of drug abuse within 5 years before signing informed consent.
- <70% compliance with usual COPD controller therapy in subjects during the screening phase.
- The investigator considers that there are any conditions that may prevent the subject from completing the study .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
Bin Cao, Ph.D, 13911318339, caobin_ben@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM326 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease（COPD）
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease.
The study consists of a screening period of up to 4 weeks, a randomized treatment period of 24 to 52 weeks, and a 12-week safety follow-up period.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- CM326 dose 1, CM326 dose 2, 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.
CM326 dose 1Drug
subcutaneous injection
CM326 dose 2Drug
subcutaneous injection
PlaceboOther
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM326 | Experimental | CM326 is dosed at two levels. Receives: Drug: CM326 dose 1; Drug: CM326 dose 2 |
| Placebo | Placebo comparator | placebo, subcutaneous (SC) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
Measured: week 24-52
Secondary outcomes (21)
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Change from baseline in FEV1 taken before bronchodilator use will be reported.
Measured: week 16-24
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Change from baseline in FEV1 taken before bronchodilator use will be reported.
Measured: week 24-52
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Change from baseline in FEV1 taken after bronchodilator use will be reported.
Measured: week 24-52
Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point
Change from baseline in forced vital capacity taken before bronchodilator use will be reported. FVC is measured by spirometer.
Measured: week 24-52
Change from baseline in forced expiratory flow (FEF) at 25%-75% at each evaluation time point
FEF is measured by spirometer.
Measured: week 24-52
Time to the first onset of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Time to first moderate or severe AECOPD over the placebo-controlled treatment period.
Measured: week 24-52
Time to the first onset of Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Time to first severe AECOPD over the placebo-controlled treatment period.
Measured: week 24-52
Annualized Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Annualized rate of severe AECOPD over the placebo-controlled treatment period.
Measured: week 24-52
Change from baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at each evaluation time point
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Measured: week 24-52
Proportion of participants with an SGRQ Score improvement of ≥4 points from baseline at each evaluation time point.
Proportion of participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) will be reported.
Measured: week 24-52
Change from baseline in COPD assessment test (CAT) Total Score at each evaluation time point
CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.
Measured: week 24-52
Proportion of participants with an CAT Score improvement of ≥2 points from baseline at each evaluation time point
Proportion of participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) will be reported.
Measured: week 24-52
Change from baseline in Evaluating Respiratory Symptoms (E-RS) total score at each evaluation time point
The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis. The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.
Measured: week 24-52
Proportion of participants with an E-RS Score improvement of ≥2 points from baseline at each evaluation time point
Proportion of participants achieving a clinically meaningful improvement from baseline in E-RS total score (2-point score decrease) will be reported.
Measured: week 24-52
Incidence of Adverse events (AEs)/treatment-emergent adverse events (TEAEs) in
The severity of adverse events is recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0. The incidence of participants with adverse events (AE) will be calculated.
Measured: week 64
Blood drug concentration Pharmacokinetic profile of CM326
Measured: week 64
Pharmacodynamics profile of CM326 Change from baseline fractional exhaled nitric oxide (FeNO)
Evaluate the changes from baseline in FeNO at each visit point.
Measured: week 64
Change from baseline in peripheral blood eosinophil
Evaluate the changes from baseline in blood eosinophil count at each visit point.
Measured: week 64
Change from baseline in total serum IgE
Evaluate the changes from baseline in total serum IgE at each visit point.
Measured: week 64
Change from baseline in interleukin-5
Evaluate the changes from baseline in blood serum IgE at each visit point
Measured: week 64
Incidence of anti-drug antibodies (ADAs)
Measured: week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start18 Dec 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
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.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418736
- Sponsor's protocol ID
- CM326-003
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM326 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease（COPD）
- ClinicalTrials.gov ID
- NCT07418736
- Acronym / sponsor ID
- CM326-003
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 18 Feb 2026 (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 multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease.
The study consists of a screening period of up to 4 weeks, a randomized treatment period of 24 to 52 weeks, and a 12-week safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM326 | Experimental | Drug: CM326 dose 1, Drug: CM326 dose 2CM326 is dosed at two levels. |
| Placebo | Placebo comparator | Other: Placeboplacebo, subcutaneous (SC) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Understand the study and voluntarily sign the informed consent form.
- Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.
- weight ≥40 kg.
- Diagnosed with COPD for at least 12 months.
- Post-bronchodilator FEV1/FVC ratio <0.70 and post-bronchodilator FEV1 % predicted ≥20% and <80%.
Key exclusion criteria (31 listed)
- A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）
- Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator. Or other conditions that could lead to elevated eosinophils.
- The presence of any severe and/or uncontrolled medical condition that in the judgment of the investigator would affect the evaluation of the drug, including but not limited to: severe neurological disease (eg, epilepsy, dementia, etc), history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation（male >450 msec, female >470 msec）, or persistent arrhythmia.
- History of malignancy.
- Previous history of known or suspected immunosuppression; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment.
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 |
|---|---|---|
| CM326 dose 1subcutaneous injection | Drug | CM326 |
| CM326 dose 2subcutaneous injection | Drug | CM326 |
| Placebosubcutaneous injection | Other | Placebo |
Primary outcome
Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Time frame: week 24-52
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
21 secondary outcomes
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
Time frame: week 16-24
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
Time frame: week 24-52
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point
Time frame: week 24-52
Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point
Time frame: week 24-52
Change from baseline in forced expiratory flow (FEF) at 25%-75% at each evaluation time point
Time frame: week 24-52
Time to the first onset of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Time frame: week 24-52
Time to the first onset of Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Time frame: week 24-52
Annualized Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations
Time frame: week 24-52
Change from baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at each evaluation time point
Time frame: week 24-52
Proportion of participants with an SGRQ Score improvement of ≥4 points from baseline at each evaluation time point.
Time frame: week 24-52
Change from baseline in COPD assessment test (CAT) Total Score at each evaluation time point
Time frame: week 24-52
Proportion of participants with an CAT Score improvement of ≥2 points from baseline at each evaluation time point
Time frame: week 24-52
Change from baseline in Evaluating Respiratory Symptoms (E-RS) total score at each evaluation time point
Time frame: week 24-52
Proportion of participants with an E-RS Score improvement of ≥2 points from baseline at each evaluation time point
Time frame: week 24-52
Incidence of Adverse events (AEs)/treatment-emergent adverse events (TEAEs) in
Time frame: week 64
Blood drug concentration Pharmacokinetic profile of CM326
Time frame: week 64
Pharmacodynamics profile of CM326 Change from baseline fractional exhaled nitric oxide (FeNO)
Time frame: week 64
Change from baseline in peripheral blood eosinophil
Time frame: week 64
Change from baseline in total serum IgE
Time frame: week 64
Change from baseline in interleukin-5
Time frame: week 64
Incidence of anti-drug antibodies (ADAs)
Time frame: week 64
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 18 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM326 dose 1 and CM326 dose 2 in people with Chronic Obstructive Pulmonary Disease, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 11 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations (time frame: week 24-52). 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 18 Feb 2026.