Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-08 @ 7:07 PM
Study NCT ID:
NCT06544720
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D010412', 'term': 'Penile Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': '28 days', 'description': 'Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)'}], 'secondaryOutcomes': [{'measure': 'Efficacy: antitumor activity of SCG142', 'timeFrame': '2 years', 'description': 'Assessed by RECIST 1.1 and iRECIST'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Papillomavirus Associated Carcinomas', 'Cervical Cancer', 'Head and Neck Cancers', 'Anal Cancer', 'Vulva Cancer', 'Vaginal Cancer', 'Penile Cancer', 'HPV-Related Malignancy']}, 'descriptionModule': {'briefSummary': 'A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Greater than or equal to 18 years of age\n2. HPV associated carcinomas\n3. Patients must have at least one measurable lesion defined by RECIST 1.1\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nKey Exclusion Criteria:\n\n1. Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.\n2. Patients with active autoimmune diseases.\n3. Patient has a known active Hepatitis B or Hepatitis C.\n4. Other severe medical conditions that may limit subject\\'s participation in this trial.'}, 'identificationModule': {'nctId': 'NCT06544720', 'briefTitle': 'SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'A Phase 1 Clinical Study of Autologous TCR-T Cells (SCG142) Therapy for Advanced HPV Associated Carcinomas', 'orgStudyIdInfo': {'id': 'SCG142-CI-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCG142 TCR-T cells', 'description': 'Monotherapy of SCG142', 'interventionNames': ['Biological: SCG142 TCR-T cells']}], 'interventions': [{'name': 'SCG142 TCR-T cells', 'type': 'BIOLOGICAL', 'description': 'Monotherapy of SCG142', 'armGroupLabels': ['SCG142 TCR-T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266071', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongying Lv', 'role': 'CONTACT', 'email': 'qdlhytiger@163.com', 'phone': '18661805217'}], 'facility': 'The affiliated hosptial of qingdao university', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Hongying Lv', 'role': 'CONTACT', 'email': 'qdlhytiger@163.com', 'phone': '+86 18661805217'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}