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A Study of CDX-622 in Participants With Mild to Moderate Asthma

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full 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 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.

About the study

This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.

What is being tested

Sponsor: Celldex Therapeutics · Participants: 12 · Started: Jun 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07330778

Locations in the U.S.

CaliforniaUniversity of California, San Francisco, San Francisco
KansasThe University of Kansas Medical Center, Kansas City
MassachusettsBrigham and Women's Hospital, Boston
PennsylvaniaUniversity of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC, Pittsburgh

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.