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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

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)

A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT07418736) is a Phase 2 interventional studying Chronic Obstructive Pulmonary Disease, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Obstructive Pulmonary Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 318 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Understand the study and voluntarily sign the willing to sign a consent form form. 2. Age ≥40 and ≤85 years old, male or female, at the time of signing the willing to sign a consent form. 3. weight ≥40 kg. 4. Diagnosed with COPD for at least 12 months. 5. Post-bronchodilator FEV1/FVC ratio \<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \<80%. 6. Background therapy for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening. 7. Exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening. 8. COPD assessment test (CAT) Total Score ≥10. 9. Blood eosinophils ≥0.15×10\^9 /L at screening. 10. 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. 11. Voluntarily use highly effective contraception from the time of signing the willing to sign a consent form form until 3 months after the last dose. Who Should NOT Join This Trial: 1. 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) 2. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Understand the study and voluntarily sign the informed consent form. 2. Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent. 3. weight ≥40 kg. 4. Diagnosed with COPD for at least 12 months. 5. Post-bronchodilator FEV1/FVC ratio \<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \<80%. 6. Background therapy for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening. 7. Exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening. 8. COPD assessment test (CAT) Total Score ≥10. 9. Blood eosinophils ≥0.15×10\^9 /L at screening. 10. 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. 11. Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose. Exclusion Criteria: 1. 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) 2. 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. 3. 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. 4. History of malignancy. 5. Previous history of known or suspected immunosuppression; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment. 6. 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. 7. Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the investigator or with evidence of right cardiac failure. 8. Myocardial infarction, unstable angina, or stroke occurring within 6 months prior to signing the informed consent form (ICF). 9. 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. 10. Acute moderate or severe exacerbation of COPD from 4 weeks before signing consent to the time of randomization. 11. Acute infection requiring systemic anti-infective therapy from 4 weeks before signing consent to the time of randomization. 12. Major surgery within 8 weeks prior to consent or planned surgery requiring general anesthesia or hospitalization for \> 1 day during the study period. 13. History of or planned pneumonectomy or lung volume reduction surgery for COPD 12 months prior to screening. 14. 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. 15. 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). 16. 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. 17. Use of macrolide antibiotics (eg, azithromycin) unless stable \>3 months prior to screening visit and maintain the treatment during the planned study period. 18. 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).。 19. 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. 20. 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. 21. Received immune globulin or blood products within 30 days before informed consent. 22. 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. 23. Receipt of live or attenuated vaccine within 3 months before consent signing or during the planned study period. 24. Non-negative HIV serological test result at screening, or Treponema pallidum infection requiring treatment. 25. 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. 26. 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. 27. Females with a positive pregnancy test, pregnant females, or lactating females. 28. Allergy or intolerance to components of CM326 injection or placebo or history of severe drug allergy or anaphylactic shock. 29. History of drug abuse within 5 years before signing informed consent. 30. \<70% compliance with usual COPD controller therapy in subjects during the screening phase. 31. The investigator considers that there are any conditions that may prevent the subject from completing the study .

Treatments Being Tested

DRUG

CM326 dose 1

subcutaneous injection

DRUG

CM326 dose 2

subcutaneous injection

OTHER

Placebo

subcutaneous injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

China-Japan Friendship Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07418736), the sponsor (CSPC ZhongQi Pharmaceutical Technology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07418736 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07418736?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07418736?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07418736. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07418736. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.