Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT03931720
Status:
UNKNOWN
Last Update Posted:
2019-04-30
First Post:
2019-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-27', 'studyFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2019-04-27', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of treatment related adverse events as assessed by CTCAE v4.03', 'timeFrame': '1 year', 'description': 'Defined as \\>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18\\~75 years old, male or female\n2. Life expectancy ≥ 6 months\n3. ECOG score: 0-3\n4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)\n5. Advanced solid tumor was diagnosed by pathological or clinical physicians\n6. Laboratory examination: white blood cell≥3 x 10\\*9/L, blood platelet count≥70 x 10\\*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level\n7. Signed informed consent\n8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion\n\nExclusion Criteria:\n\n1. Expected overall survival \\< 6 months\n2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\\> Class II, NYHA), or myocardial infarction within 6 months\n3. Abnormal lung function: FEV (forced expiratory volume) \\< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \\< 30% prediction, blood oxygen saturation \\< 90%\n4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.\n5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements'}, 'identificationModule': {'nctId': 'NCT03931720', 'briefTitle': 'Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asclepius Technology Company Group (Suzhou) Co., Ltd.'}, 'officialTitle': 'Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor', 'orgStudyIdInfo': {'id': 'AsclepiusTCG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)', 'description': 'Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells).', 'interventionNames': ['Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)']}], 'interventions': [{'name': 'BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)', 'type': 'BIOLOGICAL', 'description': 'The subject will be observed for any side effects during this time and all the adverse events will be recorded.', 'armGroupLabels': ['anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215021', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fengchun Zhang, PhD', 'role': 'CONTACT', 'email': 'fczhang2004@163.com'}], 'facility': 'Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Guangfu Li', 'role': 'CONTACT', 'email': 'lgf@atcgcell.com', 'phone': '+86 13615181959'}, {'name': 'Xianfeng Feng', 'role': 'CONTACT', 'email': 'fxf@atcgcell.com', 'phone': '+86 15157190521'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asclepius Technology Company Group (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}