Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-21 @ 10:24 PM
Study NCT ID:
NCT06650761
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2024-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of CDX-622
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.', 'timeFrame': 'Day 1 up to Day 127', 'description': 'To evaluate the safety profile as determined by the incidence of adverse events in single or multiple ascending doses of CDX-622 or placebo comparator in healthy participants.'}], 'secondaryOutcomes': [{'measure': 'CDX-622 serum evaluations over time', 'timeFrame': 'Day 1 up to Day 127', 'description': 'CDX-622 serum concentrations will be measured at specified visits'}, {'measure': 'CDX-622 biomarker evaluations over time', 'timeFrame': 'Day 1 up to Day 127', 'description': 'The effect of CDX-622 on serum tryptase levels and other relevant biomarkers'}, {'measure': 'Measurement of anti-drug antibody development over time', 'timeFrame': 'Day 1 up to Day 127', 'description': 'Participants will be monitored for the development of anti-drug antibodies'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This is a study to determine the safety of CDX-622 in healthy participants.', 'detailedDescription': 'CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).\n\nThis study will evaluate the safety, pharmacokinetics, and Pharmacodynamics of IV single ascending doses (Part 1), IV multiple ascending doses (Part 2), and subcutaneous (SC) single ascending doses (Part 3) of CDX-622 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* An informed consent signed and dated by the participant.\n* Healthy volunteer aged 18-55.\n* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.\n* Body mass index (BMI) ≥ 18 kg/m2 to ≤ 32 kg/m2.\n* No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.\n* Both males and females of childbearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.\n* Not a current smoker (or regular user of any nicotine containing product).\n* Willing to follow all study rules.\n\nKey Exclusion Criteria:\n\n* Women who are pregnant or nursing.\n* History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication.\n* History of asthma requiring the use of inhaled medication within the past 5 years.\n* Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).\n* Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.\n* Positive urine test for alcohol and drugs of abuse.\n\nAdditional protocol defined inclusion and exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT06650761', 'briefTitle': 'A Phase I Study of CDX-622', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celldex Therapeutics'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Three-Part, Phase 1a Dose Escalation Clinical Trial to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-622 in Healthy Participants', 'orgStudyIdInfo': {'id': 'CDX622-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CDX-622', 'description': 'Eligible participants will receive doses of CDX-622 by IV or SC', 'interventionNames': ['Drug: CDX-622']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Eligible participants will receive doses of Normal Saline by IV or SC', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'CDX-622', 'type': 'DRUG', 'description': 'Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622', 'armGroupLabels': ['CDX-622']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Up to 4 infusions or 6 SC injections of normal saline', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacob Landolt', 'role': 'CONTACT', 'phone': '602-437-0097'}], 'facility': 'Celerion, Inc.', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'centralContacts': [{'name': 'Celldex Therapeutics', 'role': 'CONTACT', 'email': 'clinicaltrials@celldex.com', 'phone': '844-723-9363'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celldex Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}