CDX-622 for adults with mild to moderate asthma
Official title: An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma
Run by Celldex Therapeutics · NCT07330778 · Data updated 2026-11-12
This study will test a single IV dose of CDX-622 in adults with mild to moderate asthma to see if it is safe and how the drug behaves in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Celldex Therapeutics Industry-sponsored |
| Drugs / interventions | tezepelumab, briquilimab |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07330778 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with physician-diagnosed mild to moderate asthma for at least 12 months, pre-bronchodilator FEV1 ≥70% predicted and bronchodilator reversibility ≥12% (≥200 mL), who can attend site visits and follow contraception requirements are the intended participants.
✕Probably not a fit
People who are pregnant or nursing, have severe or uncontrolled asthma, other pulmonary diseases, recent smoking or vaping, active infections, or recent need for systemic corticosteroids are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
CDX-622 is a bispecific antibody that binds stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). In this Phase 1 trial, eligible adults with mild to moderate asthma will receive a single intravenous infusion of CDX-622 and be followed through 12 weeks for safety, pharmacodynamics (PD), and pharmacokinetics (PK). Researchers will collect blood samples, monitor lung function (including FEV1 and bronchodilator response), and record adverse events during scheduled follow-up visits. The protocol excludes participants with severe or uncontrolled asthma, recent smoking or vaping, other pulmonary disease, or active infections such as TB, hepatitis, or HIV.
Why it matters
Potential benefit: If successful, CDX-622 could reduce airway inflammation by blocking SCF and TSLP and potentially improve asthma control with a novel biologic approach.
How similar studies have gone: TSLP-targeting therapies have shown clinical benefit in asthma (for example, tezepelumab), but a bispecific antibody that also targets SCF is a novel approach with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Males and females, ≥ 18 years of age 2. Diagnosis of mild to moderate asthma for at least 12 months 3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal 4. Airway reversibility ≥ 12% and 200 mL improvement in FEV1 5. Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment 6. Willing and able to comply with all study requirements and procedures Key Exclusion Criteria: 1. Females who are pregnant or nursing 2. Pulmonary disease other than asthma 3. Systemic diseases with elevated eosinophils other than asthma 4. Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months 5. History of needing ventilator support due to asthma 6. Current nasal polyps 7. Severe or uncontrolled asthma 8. History of smoking or vaping within the past 6 months 9. Tuberculosis, hepatitis B or C virus, or HIV 10. Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics. 11. Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab Additional protocol defined inclusion and exclusion criteria could apply.
Where it's running
-
University of California, San Francisco
San Francisco, California, United States Recruiting -
The University of Kansas Medical Center
Kansas City, Kansas, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Celldex Therapeutics
- Email: clinicaltrials@celldex.com
- Phone: 844-723-9363
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.