Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Monida Tang, MD (ucsf)

Description

Summary

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

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

Details

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).

Keywords

Mild to Moderate Asthma, Asthma, Mild to moderate, CDX-622

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • The University of Kansas Medical Center accepting new patients
    Kansas City Kansas 66160 United States
  • University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC accepting new patients
    Pittsburgh Pennsylvania 15213 United States
  • Brigham and Women's Hospital accepting new patients
    Boston Massachusetts 02115 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celldex Therapeutics
ID
NCT07330778
Phase
Phase 1 Asthma Research Study
Study Type
Interventional
Participants
Expecting 12 study participants
Last Updated