Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT07246304
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To investigate the Cmax of TC-D101 CAR-T cells in the peripheral blood after infusion', 'timeFrame': 'Up to 24 months'}, {'measure': 'To assess TC-D101 CAR-T cell trafficking into tumor tissues after infusion', 'timeFrame': 'Up to 24 months', 'description': 'To detect TC-D101 CAR-T cell number in tumor tissues after infusion'}], 'primaryOutcomes': [{'measure': 'Safety of TC-D101 CAR-T cells', 'timeFrame': 'Up to 24 months', 'description': 'The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.'}, {'measure': 'Safety of TC-D101 CAR-T cells', 'timeFrame': 'Up to 1 month', 'description': 'Incidence of DLT'}], 'secondaryOutcomes': [{'measure': 'Efficacy of TC-D101 CAR-T cells', 'timeFrame': 'Up to 24 months', 'description': 'Optimal objective response rate (ORR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small Cell Lung Cancer ( SCLC )', 'CAR-T Cell Therapy', 'DLL3'], 'conditions': ['Small Cell Lung Cancer ( SCLC )', 'CAR-T Cell Therapy']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small cell lung cancer(r/r SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC.', 'detailedDescription': 'This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of TC-D101 CAR-T cell therapy in patients with r/r SCLC. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) TC-D101 CAR-T cell infusion, and (5) post-infusion follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must voluntarily provide written informed consent.\n2. Aged 18-75 years (inclusive).\n3. Life expectancy ≥ 3 months.\n4. ECOG performance status 0-1.\n5. Failed or unsuitable for standard therapy.\n6. At least one measurable lesion per RECIST 1.1.\n7. DLL3-positive r/r SCLC confirmed by immunohistochemistry.\n8. Adequate organ and bone marrow function.\n9. Effective contraception required for participants of childbearing potential.\n10. Adequate venous access for leukapheresis.\n\nExclusion Criteria:\n\n1. Primary CNS malignancy or uncontrolled CNS metastases.\n2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n3. Active autoimmune disease or history of autoimmune disease.\n4. Immunodeficiency, including HIV positivity.\n5. Bleeding disorders (inherited or acquired).\n6. Clinically significant cardiovascular disease.\n7. Active infection (including tuberculosis, hepatitis B/C, syphilis).\n8. Pregnant or breastfeeding women.\n9. Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion.\n\n11\\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.'}, 'identificationModule': {'nctId': 'NCT07246304', 'briefTitle': 'TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCRCure Biopharma Ltd.'}, 'officialTitle': 'A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'D101-IIT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TC-D101 CAR-T Cell Therapy', 'description': 'Following lymphodepletion chemotherapy, participants will receive Following lymphodepletion chemotherapy, participants will receive TC-D101 CAR-T Cell CAR-T', 'interventionNames': ['Biological: TC-D101 CAR-T']}], 'interventions': [{'name': 'TC-D101 CAR-T', 'type': 'BIOLOGICAL', 'otherNames': ['Fludarabine', 'Cyclophosphamide'], 'description': 'TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.', 'armGroupLabels': ['TC-D101 CAR-T Cell Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tangfeng Hospital', 'role': 'CONTACT', 'email': 'njzyjg80863256@163.com', 'phone': '+862580863234'}], 'facility': 'The Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Tangfeng LV', 'role': 'CONTACT', 'email': 'njzyjg80863256@163.com', 'phone': '+862580863234'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCRCure Biopharma Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Jinling Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}