CDX-622 for adults with mild to moderate asthma

An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma

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
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Celldex Therapeutics (Industry-sponsored)
• Drugs / interventions: tezepelumab, briquilimab
• Locations: 2 sites (Kansas City, Kansas and 1 other locations)
• Trial ID: NCT07330778 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 or 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 12 months
9. Tuberculosis, hepatitis B or C virus, or HIV
10. Immunomodulating biologic therapies within the past 3 months
11. Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab

Additional protocol defined inclusion and exclusion criteria could apply.

Where this trial is running

Kansas City, Kansas and 1 other locations

• The University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Celldex Therapeutics

Conditions Mild to Moderate Asthma; Asthma; Mild to moderate; CDX-622