Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-03-27 @ 2:39 AM
Study NCT ID:
NCT03941457
Status:
UNKNOWN
Last Update Posted:
2019-05-08
First Post:
2019-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', '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': ['Pancreatic Cancer']}, '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 treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed metastatic pancreatic adenocarcinoma\n2. Patients aged between 18 and 75\n3. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Life expectancy greater than 3 months\n6. Subjects must have measurable disease as defined by RECIST 1.1 criteria\n7. Satisfactory organ and bone marrow function: White blood cell count (WBC) ≥ 3.0×10\\^9/L, Platelets ≥ 70×10\\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \\< 1.5 × upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration\n8. Karnofsky score ≥ 60\n9. Ability to give informed consent\n\nExclusion Criteria:\n\n1. Previously treated with any gene therapy products\n2. Patients who are receiving any other investigational agents\n3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant\n4. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses\n5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)\n6. Concurrent opportunistic infections'}, 'identificationModule': {'nctId': 'NCT03941457', 'briefTitle': 'Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asclepius Technology Company Group (Suzhou) Co., Ltd.'}, 'officialTitle': 'Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'AsclepiusTCG03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)', 'description': 'Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK cells).', 'interventionNames': ['Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)']}], 'interventions': [{'name': 'BiCAR-NK cells (ROBO1 CAR-NK 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 cells (ROBO1 CAR-NK cells)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongmin Wang, PhD', 'role': 'CONTACT', 'email': 'james0722@163.com'}], 'facility': 'Department of Radiology, Shanghai Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], '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'}}}}