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New asthma drug enters early human safety testing

NCT ID NCT07330778

Symptom relief Sponsor: Celldex Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This early-stage study tests a single dose of an experimental drug called CDX-622 in 12 adults with mild to moderate asthma. The main goal is to see if the drug is safe and to measure how it affects markers of airway inflammation. Participants will be monitored for side effects and changes in breathing over 12 weeks.

Why investors are watching

Celldex Therapeutics is testing CDX-622 in a small Phase 1 trial with 12 adults who have mild to moderate asthma. The study checks whether the drug is safe and how it works in the body, and for a small company, an early sign of safety and a hint of effect can shape its next steps.

If it works: If the drug proves safe and shows any sign of easing asthma symptoms, Celldex could move it into larger studies. That progress could raise the drug's value and attract partners or funding.

If it fails: Phase 1 trials often fail on safety or show no clear benefit, and this one has only 12 participants, so results may be inconclusive. A poor outcome could delay the program and hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild to moderate asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • The University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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