Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-22 @ 8:34 AM
Study NCT ID:
NCT03638193
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2017-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of CART-meso infusion: number of adverse events', 'timeFrame': '60 months', 'description': 'Number of Adverse Events evaluated with NCI CTC AE, version 4.0\\[Safety evaluation\\]'}], 'secondaryOutcomes': [{'measure': 'Clinical response of CART-meso', 'timeFrame': '60 months', 'description': 'Number of patients with tumor response including overal remission ,complete ression,progression-free survival，progressive disease ,etc.'}, {'measure': 'CAR-T cell detection', 'timeFrame': '60 months', 'description': 'Detection of transferred T cells in peripheral blood or bone marrow using multi-parameter flow cytometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': "This is a study in which pancreatic cancer patients receive a immunotherapy with CART-meso cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells lentivirally transduced to express anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains.The lymphodepletion with cyclophosphamide may prolong the persistence of CART cells.", 'detailedDescription': 'This study is being conducted to assess the safety and efficacy of immunotherapy with CART-meso cells in dose escalation design. The trial will begin in Cohort 1 and progress to Cohorts 2, depending upon dose limiting toxicity (DLT) assessment .\n\nSubjects will be enrolled serially, but infusions will be staggered to allow assessment of DLTs for determination of cohort progression, expansion, or dose de-escalation.\n\nCohort 1 subjects will receive a single dose of 1-3x10\\^7 /m\\^2 lentiviral transduced CART-meso cells after conditioning chemotherapeutic regimen.\n\nCohort 2 subjects will receive a single dose of 1-3x10\\^8 /m\\^2 lentiviral transduced CART-meso cells cells after conditioning chemotherapeutic regimen.\n\nDose limiting toxicity is defined as any adverse reactions at level 3 or above that may be associated with CART-meso within 4 weeks after infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Unresectable or metastatic pancreatic cancer\n* Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease\n* 18 - 70 years of age\n* ECOG performance status of 0 or 1\n* Life expectancy greater than 3 months\n* Satisfactory organ and bone marrow function\n* Meets blood coagulation parameters\n* Male and Female subjects of reproductive potential agree to use approved contraceptive methods\n\nExclusion Criteria:\n\n* Participation in a therapeutic investigational study within 4 weeks prior to the screening visit\n* Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion\n* Active invasive cancer other than pancreatic cancer\n* HIV, HCV, or HBV infections\n* Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement\n* Ongoing or active infection\n* Planned concurrent treatment with systemic high dose corticosteroids\n* Patients requiring supplemental oxygen therapy\n* Prior therapy with gene modified cells\n* Previous experimental therapy with SS1 moiety, murine or chimeric antibodies\n* History of allergy to murine proteins\n* History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)\n* Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT03638193', 'briefTitle': 'Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen BinDeBio Ltd.'}, 'officialTitle': 'Study of Autologous T-cells Redirected to Mesothelin With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': '2017NJYY-Meso'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CART-meso cells', 'description': 'A single dose of CART-meso T cells will be administered intravenously.The dose is 1-3×10\\^7/m\\^2 CART positive cells(chort 1)or 1-3×10\\^8/m\\^2 CART positive cells(chort 2).', 'interventionNames': ['Biological: CART-meso cells']}], 'interventions': [{'name': 'CART-meso cells', 'type': 'BIOLOGICAL', 'description': 'CART-meso is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m\\^2 of cyclophosphamide, which will be administered according to standard procedures, Thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects.', 'armGroupLabels': ['CART-meso cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinfei CHEN, MD, PhD', 'role': 'CONTACT', 'phone': '(+86)18951670922'}, {'name': 'Jinfei CHEN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hongling ZHANG, PhD', 'role': 'CONTACT', 'email': 'hl.zhang@bindebio.com', 'phone': '(+86)0755-86387905'}], 'overallOfficials': [{'name': 'Jinfei CHEN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen BinDeBio Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}