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CDX-622

Phase 1

Mild to Moderate Asthma | Small molecule | Respiratory |Celldex Therapeutics, Inc.|Trials Updated: Jul 2, 2026

CDX-622 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2024

CDX-622 target and mechanism

Molecular targetTSLP
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

CDX-622 clinical trials

CDX-622 · 1 trial · 1 indication

Phase 1 1
NCT07330778A Study of CDX-622 in Participants With Mild to Moderate AsthmaMild to Moderate Asthma
RECRUITING12 Analytics
PHASE1RECRUITING
A Study of CDX-622 in Participants With Mild to Moderate Asthma
Mild to Moderate AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.

Secondary Endpoints

Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.
Day 1 up to Day 85 (12 weeks)
Change from baseline in absolute eosinophil count (AEC) through week 12.
Day 1 up to Day 85 (12 weeks)
Change from baseline through week 12 in serum biomarkers.
Day 1 up to Day 85 (12 weeks)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CDX-622EXPERIMENTALEligible participants will receive a single dose

Interventions

NameTypeDescription
CDX-622DRUGAdministered Intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 f...

Countries:United States
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Frequently asked questions about CDX-622

What is CDX-622 used for?

CDX-622 is an investigational small molecule being developed for the treatment of mild to moderate asthma. It is currently in Phase 1 clinical development and is not approved for any indication. Celldex Therapeutics is evaluating it in adults with mild to moderate asthma in the United States.

What does CDX-622 target?

CDX-622 targets TSLP, also known as thymic stromal lymphopoietin. TSLP is a cytokine involved in airway inflammation. By targeting TSLP, CDX-622 is designed to interfere with inflammatory signaling relevant to asthma. It is a small molecule administered as an investigational therapy.

Who is developing CDX-622?

CDX-622 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol CLDX. Celldex is the sponsor of the ongoing Phase 1 study of CDX-622 in participants with mild to moderate asthma.

What phase is CDX-622 in?

CDX-622 is in Phase 1 clinical development. The only listed trial is a Phase 1 study that is currently recruiting participants. CDX-622 is investigational and has not been approved by the FDA for any use.

What clinical trials is CDX-622 in?

CDX-622 is being studied in one clinical trial, NCT07330778, titled A Study of CDX-622 in Participants With Mild to Moderate Asthma. The trial is a Phase 1, uncontrolled study recruiting 12 participants aged 18 years and older in the United States. It is currently active and recruiting.