Recruiting
Phase 1

CDX-622

Sponsor:

Celldex Therapeutics

Code:

NCT07330778

Conditions

Mild to Moderate Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CDX-622

Study Details

Brief summary:

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

Conditions

Mild to Moderate Asthma

Study ID

NCT07330778

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CDX-622

Eligible participants will receive a single dose

Interventions

CDX-622

Administered Intravenously

Primary outcome measure

  • To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma. [ Time Frame: Day 1 up to Day 85 (12 weeks) ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jamie Quigley, RRT, RPFT, AE-C, CCRC

913-574-3036jtroxel@kumc.edu

Victoria Dorman, CCRC

913-588-1833vdorman@kumc.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Maria Angeles Cinelli

arc@bwh.harvard.edu

University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

Celldex Therapeutics

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Asthma
  • Mild to moderate
  • CDX-622

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Celldex Therapeutics on 2026-07-02.