Mild to Moderate AsthmaPhase 1NCT07330778
A Study of CDX-622 in Participants With Mild to Moderate Asthma
A Phase 1 study testing CDX-622 in people with Mild to Moderate Asthma, run by Celldex Therapeutics at 4 sites in United States.
Trial summary
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Asthma
- What is being tested?
- CDX-622
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ≥ 18 years of age
- Diagnosis of mild to moderate asthma for at least 12 months
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal
- Airway reversibility ≥ 12% and 200 mL improvement in FEV1
- Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment
- Willing and able to comply with all study requirements and procedures
Who cannot join
- Females who are pregnant or nursing
- Pulmonary disease other than asthma
- Systemic diseases with elevated eosinophils other than asthma
- Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months
- History of needing ventilator support due to asthma
- Current nasal polyps
Show all 12Show fewer
- Severe or uncontrolled asthma
- History of smoking or vaping within the past 6 months
- Tuberculosis, hepatitis B or C virus, or HIV
- Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics.
- Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab
- Additional protocol defined inclusion and exclusion criteria could apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Maria Angeles Cinelli, arc@bwh.harvard.edu
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Jamie Quigley, RRT, RPFT, AE-C, CCRC, 913-574-3036, jtroxel@kumc.edu
Victoria Dorman, CCRC, 913-588-1833, vdorman@kumc.edu
- Recruiting
University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC
Pittsburgh, Pennsylvania, 15213
Logan Sullivan, 412-639-0585, sullivanlt@upmc.edu
Taylor Nee, 412-463-7728, neet2@upmc.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Mariana Mosqueda, Mariana.Mosqueda@ucsf.edu
Christine Nguyen, Christine.Nguyen@ucsf.edu
About this study
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
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
Read the 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).
- Conditions
- Mild to Moderate Asthma
- Being tested
- CDX-622
- Keywords
- Asthma, Mild to moderate, CDX-622
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-622Drug
Administered Intravenously
| Study group | Role | What they receive |
|---|---|---|
| CDX-622 | Experimental | Eligible participants will receive a single dose Receives: Drug: CDX-622 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma.
Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.
Measured: Day 1 up to Day 85 (12 weeks)
Secondary outcomes (4)
Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.
Pre-treatment and post-treatment FeNO levels will be measured at specified visits and analyzed to evaluate changes from baseline in airway inflammation.
Measured: Day 1 up to Day 85 (12 weeks)
Change from baseline in absolute eosinophil count (AEC) through week 12.
Pre-treatment and post treatment blood samples will be collected at specified visits and analyzed for changes in AEC.
Measured: Day 1 up to Day 85 (12 weeks)
Change from baseline through week 12 in serum biomarkers.
Pre-treatment and post-treatment blood samples will be collected at specified visits and analyzed for changes in TSLP- and SCF-related serum biomarkers.
Measured: Day 1 up to Day 85 (12 weeks)
Pharmacokinetic (PK) evaluation from baseline through week 12.
CDX-622 serum concentrations measured at specific visits.
Measured: Day 1 up to Day 85 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330778
- Sponsor's protocol ID
- CDX622-02
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07330778
- Acronym / sponsor ID
- CDX622-02
- Conditions
- Mild to Moderate Asthma
- Keywords
- Asthma, Mild to moderate, CDX-622
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDX-622 | Experimental | Drug: CDX-622Eligible participants will receive a single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females, ≥ 18 years of age
- Diagnosis of mild to moderate asthma for at least 12 months
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal
- Airway reversibility ≥ 12% and 200 mL improvement in FEV1
- Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment
Key exclusion criteria (12 listed)
- Females who are pregnant or nursing
- Pulmonary disease other than asthma
- Systemic diseases with elevated eosinophils other than asthma
- Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months
- History of needing ventilator support due to asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDX-622Administered Intravenously | Drug | CDX-622 |
Primary outcome
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.
4 secondary outcomes
Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.
Time frame: 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)
Change from baseline through week 12 in serum biomarkers.
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mild to Moderate Asthma
RecruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
Healthy Volunteer Study, Healthy Adults
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
RecruitingPhase 1
Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With Asthma
Asthma, Healthy Volunteers
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDX-622 in people with Mild to Moderate Asthma, run by Celldex Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celldex Therapeutics (844-723-9363, clinicaltrials@celldex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.