CDX-622 for Asthma

Overseen By Celldex Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celldex Therapeutics

Must not be taking: Immunomodulating biologics, TSLP inhibitors

Disqualifiers: Pregnancy, Pulmonary disease, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests CDX-622, an experimental treatment, to evaluate its safety and behavior in the body for individuals with mild to moderate asthma. The primary goal is to assess its safety and how the body processes the treatment. Participants will receive a single dose of CDX-622. The trial seeks adults who have had mild to moderate asthma for at least a year and have not required hospital care or strong medication recently. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, if you are on immunomodulating biologic therapies, you must not have taken them in the past 3 months to be eligible.

Is there any evidence suggesting that CDX-622 is likely to be safe for humans?

Research has shown that CDX-622 appears safe so far. In an earlier study, participants tolerated CDX-622 well, and the drug functioned smoothly in their bodies. Importantly, no major side effects occurred. This suggests the treatment might be safe for humans, at least in the short term. Additionally, CDX-622 did not trigger any unwanted reactions from the body's defense system. These early findings are encouraging for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike the standard asthma treatments, which often include inhaled corticosteroids and bronchodilators, CDX-622 offers a novel approach. CDX-622 is unique because it potentially targets asthma in a new way, possibly by affecting different pathways involved in inflammation and airway constriction. Researchers are excited about CDX-622 because it might provide relief with just a single dose, simplifying treatment and improving compliance for patients. This could revolutionize asthma management by offering a more convenient and potentially more effective option than current therapies.

What evidence suggests that CDX-622 might be an effective treatment for asthma?

Research suggests that CDX-622, which participants in this trial will receive, might help with asthma by targeting specific processes in the body. It blocks the actions of certain molecules, TSLP and SCF, linked to asthma symptoms. Early lab studies demonstrated that CDX-622 effectively stopped these actions. Initial results from other studies also showed that CDX-622 was safe to use and lowered certain markers in the blood. These findings indicate that CDX-622 could help manage asthma symptoms by reducing some inflammation processes. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with mild to moderate asthma diagnosed at least a year ago. Participants must have certain lung function levels and show improvement after using a bronchodilator. They should agree to use contraception during the study and for 5 months after, and be willing to follow all study procedures.

Inclusion Criteria

I am 18 years old or older.

Key

I have been diagnosed with mild to moderate asthma for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of CDX-622 via IV infusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CDX-622

Trial Overview

The trial is testing CDX-622's safety and effects on the body in those with mild to moderate asthma. It will look into how the drug behaves inside the body (pharmacokinetics) and its impact on asthma symptoms (pharmacodynamics).

How Is the Trial Designed?

Group I: CDX-622 Experimental Treatment 1 Intervention

Eligible participants will receive a single dose

Who Is Running the Clinical Trial?

Celldex Therapeutics

Lead Sponsor

Trials

66

Recruited

5,900+

Anthony S. Marucci

Celldex Therapeutics

Chief Executive Officer since 2008

MBA from Columbia University, MHL from Brown University

Diane C. Young

Celldex Therapeutics

Chief Medical Officer since 2019

MD from Harvard Medical School, AB in Biochemical Sciences from Harvard University

Citations

1.

ir.celldex.com

ir.celldex.com/news-releases/news-release-details/celldex-announces-initial-positive-results-phase-1-trial-cdx-622

Celldex Announces Initial Positive Results from Phase 1 ...

CDX-622 was well tolerated, exhibited a good pharmacokinetic profile and induced rapid and sustained reductions in serum tryptase, indicative of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07330778

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

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

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12590333/

Dual Inhibition of Mast Cells and Thymic Stromal ... - PMC - NIH

These data suggest that engagement of sSCF and TSLP with CDX‐622 might improve the clinical efficacy of mAb monotherapies in MC‐ and TSLP‐driven diseases.

4.

synapse.patsnap.com

synapse.patsnap.com/article/celldex-reveals-promising-preclinical-data-for-cdx-622-at-aaaai-2025

Celldex Reveals Promising Preclinical Data for CDX-622 at ...

The preclinical studies highlighted CDX-622's effectiveness in inhibiting activities driven by TSLP and SCF in vitro, showing comparable potency ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06650761

NCT06650761 | A Phase I Study of CDX-622

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/CLDX/pressreleases/37177941/celldex-expands-into-asthma-early-cdx-622-trial-signals-new-growth-angle-for-cldx/

Celldex Expands Into Asthma: Early CDX-622 Trial Signals ...

All enrolled participants receive CDX-622; there is no placebo or comparison arm. The study is open-label, which means both doctors and ...

7.

finance.yahoo.com

finance.yahoo.com/news/celldex-announces-initial-positive-results-200100892.html

Celldex Announces Initial Positive Results from Phase 1 ...

“The data presented today demonstrate that CDX-622 has a long half-life with no measurable immunogenicity observed to date—two critical hurdles ...