Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT02403505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2015-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-27', 'size': 982733, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_014.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-29T13:36', 'hasProtocol': True}, {'date': '2024-08-27', 'size': 647966, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_015.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-29T13:40', 'hasProtocol': False}, {'date': '2024-08-27', 'size': 724624, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_016.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-29T13:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '* Single Usage\n* Single Dosage'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2015-03-15', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '20 Rectal Cancer Participants with CEA blood test', 'timeFrame': 'Duration up to 90 days', 'description': 'Positive testing CEA by blood-drawing'}, {'measure': '20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen', 'timeFrame': 'Duration up to 90 days', 'description': 'Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days'}, {'measure': '20 Rectal Cancer Participants with IGRA blood test with TB antigens', 'timeFrame': 'Duration up to 90 days', 'description': '* Negative IGRA blood test with TB antigens before percutaneous use\n* Positive IGRA blood test with TB antigens after percutaneous use 21 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CEA', 'Antigen Presentation', 'APC', 'Trained Immunity', 'Innate Immune Memory', 'Rectal Cancer'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc', 'label': 'IORG0007849'}, {'url': 'http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc', 'label': 'IRB00009424'}, {'url': 'http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc', 'label': 'FWA00015357'}]}, 'descriptionModule': {'briefSummary': 'Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients.\n\n1. Treat CEA positive rectal cancer via Trained Immunity.\n2. Activate human CEA Protein Antigen Presentation Reaction.\n3. The human antigen presenting cells (APCs) can treat the CEA protein antigen into small peptide fragments, and then kill CEA positive rectal cancer cells in vivo.', 'detailedDescription': '* Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients\n* 20 CEA Positive Rectal Cancer Patients\n* Positive testing CEA by blood-drawing\n* TB negative participant is negative IGRA blood test with TB antigens\n* Clinical Rectal Cancer Diagnosis Stage 0 - IIA\n* Clinical Rectal Cancer Diagnosis without symptoms\n* Clinical Rectal Cancer Diagnosis without metastasis\n* CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix\n* By the percutaneous route with the multiple puncture device\n* Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days\n* Our trial duration will be 12-week duration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '24 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of CEA positive rectal cancer patients.\n\n20 CEA Positive Rectal Cancer Patients\n\nInclusion Criteria:\n\n* Clinical Rectal Cancer Diagnosis Stage 0 - IIA\n* Clinical Rectal Cancer Diagnosis without symptoms\n* Clinical Rectal Cancer Diagnosis without metastasis\n* Positive testing CEA by blood-drawing\n* TB negative participant is negative IGRA blood test with TB antigens.\n\nExclusion Criteria:\n\n* Pregnant\n* Thrombosis\n* Allergy\n* TB positive participant is positive IGRA blood test with TB antigens.\n* Symptoms of rectal cancer\n* Metastasis of rectal cancer\n* Evidence of critical illness'}, 'identificationModule': {'nctId': 'NCT02403505', 'acronym': 'CEA+RC-BCG', 'briefTitle': 'Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicine Invention Design, Inc'}, 'officialTitle': 'Conducting an Early Phase Clinical Trial to Assess for CEA Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of CEA Positive Rectal Cancer Patients.', 'orgStudyIdInfo': {'id': 'IND 009549'}, 'secondaryIdInfos': [{'id': 'FWA00015357', 'type': 'REGISTRY', 'domain': 'HHS, Human Protections Administrator'}, {'id': 'IORG0007849', 'type': 'REGISTRY', 'domain': 'HHS, IORG'}, {'id': 'IRB00009424', 'type': 'REGISTRY', 'domain': 'HHS, IRB'}, {'id': 'NPI-1831468511', 'type': 'REGISTRY', 'domain': 'HHS, Health Care Provider Individual'}, {'id': 'NPI-1023387701', 'type': 'REGISTRY', 'domain': 'HHS, Health Care Provider Organization'}, {'id': 'IND 009549', 'type': 'REGISTRY', 'domain': 'FDA, Investigational New Drug Application (IND)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity', 'description': 'CEA protein antigen 0.05 mg add into BCG Organism 50 MG', 'interventionNames': ['Biological: CEA protein antigen plus BCG Vaccine Mix for percutaneous use']}], 'interventions': [{'name': 'CEA protein antigen plus BCG Vaccine Mix for percutaneous use', 'type': 'BIOLOGICAL', 'otherNames': ['CEA protein antigen plus BCG Organism Mix'], 'description': '* By the percutaneous route with the multiple puncture device\n* CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix', 'armGroupLabels': ['Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20853', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'STUDY_CHAIR', 'affiliation': 'IRB00009424--NPI-1831468511'}, {'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IORG0007849--NPI-1023387701'}, {'name': 'HAN XU, MD/PhD/FAPCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IORG0007849--FWA00015357'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UnitedHealthcare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair', 'investigatorFullName': 'Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair', 'investigatorAffiliation': 'Medicine Invention Design, Inc'}}}}