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

May 22, 2026 updated by: Celldex Therapeutics

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Medical Center
        • Principal Investigator:
          • Mario Castro, MD, MPH
        • Contact:
          • Jamie Quigley, RRT, RPFT, AE-C, CCRC
          • Phone Number: 913-574-3036
          • Email: jtroxel@kumc.edu
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Elliot Israel, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Merritt L Fajt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDX-622
Eligible participants will receive a single dose
Drug: CDX-622
Administered Intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.
Day 1 up to Day 85 (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.
Time Frame: Day 1 up to Day 85 (12 weeks)
Pre-treatment and post-treatment FeNO levels will be measured at specified visits and analyzed to evaluate changes from baseline in airway inflammation.
Day 1 up to Day 85 (12 weeks)
Change from baseline in absolute eosinophil count (AEC) through week 12.
Time Frame: Day 1 up to Day 85 (12 weeks)
Pre-treatment and post treatment blood samples will be collected at specified visits and analyzed for changes in AEC.
Day 1 up to Day 85 (12 weeks)
Change from baseline through week 12 in serum biomarkers.
Time Frame: Day 1 up to Day 85 (12 weeks)
Pre-treatment and post-treatment blood samples will be collected at specified visits and analyzed for changes in TSLP- and SCF-related serum biomarkers.
Day 1 up to Day 85 (12 weeks)
Pharmacokinetic (PK) evaluation from baseline through week 12.
Time Frame: Day 1 up to Day 85 (12 weeks)
CDX-622 serum concentrations measured at specific visits.
Day 1 up to Day 85 (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX622-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild to Moderate Asthma

Clinical Trials on CDX-622

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe