Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-29 @ 1:37 AM
Study NCT ID:
NCT06505551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D010412', 'term': 'Penile Neoplasms'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital 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': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic 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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Phase 1)', 'timeFrame': '2 years', 'description': 'Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events.'}, {'measure': 'Objective response rate (ORR) (Phase 2)', 'timeFrame': '2 years', 'description': 'The proportion of patients with a complete response (CR) or partial response (PR)'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) (Phase 1)', 'timeFrame': '2 year', 'description': 'The proportion of patients with a complete response (CR) or partial response (PR)'}, {'measure': 'Duration of objective response (DOR) (Phase 1&2)', 'timeFrame': '2 year', 'description': 'The time from the first occurrence of a confirmed response to disease progression or death from any cause'}, {'measure': 'Disease control rate (DCR) (Phase 1&2)', 'timeFrame': '2 year', 'description': 'The proportion of patients with a CR, PR or stable disease (SD)'}, {'measure': 'Progression-free survival (PFS) (Phase 1&2)', 'timeFrame': '2 year', 'description': 'The time from the date of the SCG142 administration to the first occurrence of a progressive disease (PD) or death from any cause'}, {'measure': 'Overall survival (OS) (Phase 1&2)', 'timeFrame': '2 year', 'description': 'The time from date of the SCG142 administration to date of death of any cause'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (Phase 2)', 'timeFrame': '2 years', 'description': 'TEAEs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Papilloma Virus', 'HPV', 'Cervical Cancer', 'Head and Neck Cancer', 'Oropharyngeal Cancer', 'Vulvar Cancer', 'Vaginal Cancer', 'Penile Cancer', 'Anal Cancer', 'Anogenital Cancer', 'TCR T Cell', 'Cell therapy', 'T cell receptor T cell'], 'conditions': ['HPV-Related Squamous Cell Carcinoma', 'HPV-Related Cervical Squamous Cell Carcinoma', 'HPV-Related Vulvar Squamous Cell Carcinoma', 'HPV-Related Penile Squamous Cell Carcinoma', 'HPV-Related Vaginal Squamous Cell Carcinoma', 'HPV-Related Anal Squamous Cell Carcinoma', 'HPV-Related Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy', 'detailedDescription': 'This study will be conducted in 2 parts:\n\nThe Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.\n\nThe Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.\n2. Tumor tissue positive for HPV16 or HPV52.\n3. Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy.\n4. Human leukocyte antigen (HLA)-A\\*02:01 genotype.\n5. Measurable disease as defined by RECIST v1.1.\n6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.\n7. Anticipated life expectancy ≥3 months.\n8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.\n\nMain Exclusion Criteria:\n\n1. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.\n2. Active brain metastasis or leptomeningeal metastases.\n3. History of other malignancy within 2 years prior to Screening.\n4. History of organ transplant.\n5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n6. History of active cardiac disease.\n7. History of active pulmonary disease.\n8. Active, known, or suspected autoimmune disease.\n9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.\n10. Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.\n11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.\n12. Any serious medical condition or abnormality in clinical laboratory tests.'}, 'identificationModule': {'nctId': 'NCT06505551', 'briefTitle': 'Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'SCG Cell Therapy Pte. Ltd.'}, 'officialTitle': 'A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas', 'orgStudyIdInfo': {'id': 'SCG142-UR-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCG142 T cells', 'description': 'This is a single arm study.', 'interventionNames': ['Biological: SCG142', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}], 'interventions': [{'name': 'SCG142', 'type': 'BIOLOGICAL', 'description': 'Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy', 'armGroupLabels': ['SCG142 T cells']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'for 3 consecutive days', 'armGroupLabels': ['SCG142 T cells']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'for 3 consecutive days', 'armGroupLabels': ['SCG142 T cells']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SCG Cell Therapy', 'role': 'CONTACT', 'email': 'clinicaltrials@scgcell.com', 'phone': '(65) 6829 7180'}], 'overallOfficials': [{'name': 'SCG Cell Therapy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SCG Cell Therapy Pte. Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCG Cell Therapy Pte. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}