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A Study of CDX-622 in Participants With Mild to Moderate Asthma
NCT07330778 · Celldex Therapeutics
In plain English
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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
About this study
CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). Eligible participants with mild to moderate asthma will receive a single dose of CDX-622 via IV infusion. Additional follow-up visits will be required through EOS (week 12).
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.
Study design
Enrollment target: 12 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02
Estimated completion: 2027-03
Last updated: 2026-04-01
Interventions
Drug: CDX-622
Primary outcomes
- • To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma. (Day 1 up to Day 85 (12 weeks))
Sponsor
Celldex Therapeutics · industry
Contacts & investigators
ContactCelldex Therapeutics · contact · clinicaltrials@celldex.com · 844-723-9363
All locations (2)
The University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States