Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-04-23 @ 4:55 PM
Study NCT ID:
NCT03185468
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2017-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention of Bladder Cancer by CAR-T
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2017-06-10', 'studyFirstSubmitQcDate': '2017-06-10', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival rate after receiving 4SCART infusion', 'timeFrame': '1 year', 'description': 'to determine the efficacy of 4SCAR T cells'}, {'measure': 'Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion', 'timeFrame': '3 months', 'description': 'to evaluate the level of adverse events with CTCAE 4'}], 'secondaryOutcomes': [{'measure': 'The expansion and persistence of 4SCAR T cells', 'timeFrame': '1 year', 'description': 'The investigators will monitor the expansion and functional persistence of 4SCAR T cells in the peripheral blood of patients and the correlation with antitumor effects'}, {'measure': 'Immune responses after infusions', 'timeFrame': '3 months', 'description': 'assessment of cytokine profile'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR T', 'Bladder'], 'conditions': ['Bladder Cancer', 'Urothelial Carcinoma Bladder']}, 'descriptionModule': {'briefSummary': 'This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)\n2. Representative tumor specimens as specified by the protocol\n3. Adequate hematologic and end organ function\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Life expectancy greater than or equal to (\\>/=) 12 weeks\n6. Measurable disease, as defined by RECIST v1.1\n\nExclusion Criteria:\n\n1. Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment\n2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment\n3. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments\n4. Leptomeningeal disease\n5. Malignancies other than UBC within 5 years prior to Cycle 1, Day 1\n6. Pregnant and lactating women\n7. Significant cardiovascular disease\n8. Severe infections within 4 weeks prior to infusion\n9. Major surgical procedure other than for diagnosis within 4 weeks\n10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation\n11. History of autoimmune disease\n12. Prior allogeneic stem cell or solid organ transplant\n13. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n14. Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis'}, 'identificationModule': {'nctId': 'NCT03185468', 'briefTitle': 'Intervention of Bladder Cancer by CAR-T', 'organization': {'class': 'OTHER', 'fullName': 'Shenzhen Geno-Immune Medical Institute'}, 'officialTitle': 'Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies', 'orgStudyIdInfo': {'id': 'GIMI-IRB-17004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4SCAR-PSMA', 'description': '4SCAR PSMA-modified T cells can recognize and kill tumor cells through the recognize of PSMA .This study will evaluate the side effects and effective doses of 4SCAR-PSMA T cells in treating refractory and recurrent solid tumors.', 'interventionNames': ['Genetic: 4SCAR-PSMA']}, {'type': 'EXPERIMENTAL', 'label': '4SCAR-FRa', 'description': '4SCAR FRa-modified T cells can recognize and kill tumor cells through the recognize of FRa .This study will evaluate the side effects and effective doses of 4SCAR-FRa T cells in treating refractory and recurrent solid tumors.', 'interventionNames': ['Genetic: 4SCAR-FRa']}], 'interventions': [{'name': '4SCAR-PSMA', 'type': 'GENETIC', 'description': 'PSMA-specific 4th Generation CART', 'armGroupLabels': ['4SCAR-PSMA']}, {'name': '4SCAR-FRa', 'type': 'GENETIC', 'description': 'FRa-specific 4th Generation CART', 'armGroupLabels': ['4SCAR-FRa']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'state': 'Gongdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'AiFa Tang, Ph. D', 'role': 'CONTACT', 'email': 'tangaifa2004@163.com'}], 'facility': 'Shenzhen Second People Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lung-Ji Chang, PhD', 'role': 'CONTACT', 'email': 'c@szgimi.org', 'phone': '86-13671121909'}], 'facility': 'Shenzhen Geno-immune Medical Institute', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Lung-Ji Chang, PhD', 'role': 'CONTACT', 'email': 'c@szgimi.org', 'phone': '86-13671121909'}, {'name': 'Aifa Tang, PhD', 'role': 'CONTACT', 'email': 'tangaifa2004@163.com'}], 'overallOfficials': [{'name': 'Lung-Ji Chang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenzhen Geno-Immune Medical Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Geno-Immune Medical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Lung-Ji Chang', 'investigatorAffiliation': 'Shenzhen Geno-Immune Medical Institute'}}}}