Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-06 @ 4:51 AM
Study NCT ID:
NCT02862028
Status:
UNKNOWN
Last Update Posted:
2016-08-25
First Post:
2016-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2016-08-07', 'studyFirstSubmitQcDate': '2016-08-07', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '2 years'}, {'measure': 'Disease control rate,(DCR)', 'timeFrame': '2 years'}, {'measure': 'Overall survival', 'timeFrame': '2 years'}, {'measure': 'Progress-free survival(PFS)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'Questionnaire will be used.'}]}, 'conditionsModule': {'keywords': ['PD-1 antibody', 'CAR-T cells', 'EGFR family', 'advanced solid tumor'], 'conditions': ['PD-1 Antibody', 'CAR-T Cells', 'Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nTo evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.\n\nEligibility:\n\nIndividuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.', 'detailedDescription': 'A total of 20 patients may be enrolled over a period of 1-2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18\\~65 years old, male or female;\n2. Life expectancy≥6 months;\n3. ECOG score: 0-3;\n4. Advanced solid tumor (lung cancer, gastric cancer, liver cancer) were diagnosed by pathological or clinical physicians;\n5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;\n6. Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and IGFR1 protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;\n7. Laboratory examination: white blood cell≥3 x 10\\*9/L, blood platelet count≥60 x 10\\*/L, hemoglobin≥85g/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；\n8. Signed informed consent；\n9. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells 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': 'NCT02862028', 'briefTitle': 'PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai International Medical Center'}, 'officialTitle': 'A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)', 'orgStudyIdInfo': {'id': 'SIMC-20160101/02/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HerinCAR-PD1 cells', 'description': 'Patients will receive 3 cycles of HerinCAR-PD1 cells treatment.', 'interventionNames': ['Biological: HerinCAR-PD1 cells']}], 'interventions': [{'name': 'HerinCAR-PD1 cells', 'type': 'BIOLOGICAL', 'description': 'herinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43.', 'armGroupLabels': ['HerinCAR-PD1 cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201318', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Naiyan Han', 'role': 'CONTACT', 'email': 'naiyan.han@simcgroup.com', 'phone': '+86 (0) 182 1766 2469'}], 'facility': 'Shanghai International Medical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Naiyan Han', 'role': 'CONTACT', 'email': 'naiyan.han@simcgroup.com', 'phone': '+86 21 6023 6666'}], 'overallOfficials': [{'name': 'Naiyan Han', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai International Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai International Medical Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}