Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03488160
Status:
UNKNOWN
Last Update Posted:
2018-04-10
First Post:
2018-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-07', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measure: The overall efficiency', 'timeFrame': '[Time Frame: 3 years]', 'description': 'Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lymphoma CAR-T'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.', 'detailedDescription': "The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age is 16 years old, less than 70 years old, sex is not limited, race is not limited;\n2. The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation;\n3. The patient needs to have a lesion that can be used to detect or evaluate the disease.\n4. 0\\~1 score of physical status score of the eastern cancer cooperation group (ECOG).\n5. At the time of collection of peripheral white blood cell counts over 1 \\* 10\\^9/L;\n6. Expected survival time \\> 90 days;\n7. Patients have the ability to know and sign informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Uncontrolled infection;\n3. HIV infected people, hepatitis B or HCV active stage;\n4. Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.).\n5. Combined with active central nervous system malignant tumor invading;\n6. Has abnormal coagulation function, and there are patients with serious thrombus.\n7. Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system.\n8. Patients who participated in other clinical trials in the past 30 days or in other clinical trials;\n9. Researchers believe that patients are not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT03488160', 'briefTitle': 'CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinobioway Cell Therapy Co., Ltd.'}, 'officialTitle': 'CAR-T Cell Therapy for Relapsed / Refractory CD19 Positive Clinical Study on the Safety and Effectiveness of Lymphoma', 'orgStudyIdInfo': {'id': 'sinobiowayCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:the first day,the second day Duration:total two times', 'interventionNames': ['Biological: CD19-targeted CAR-T cells']}], 'interventions': [{'name': 'CD19-targeted CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guolin Wu', 'role': 'CONTACT', 'email': 'wgldoctor@sina.com', 'phone': '13855105487'}, {'name': 'Kaiyang Ding', 'role': 'CONTACT', 'email': 'dingkaiy@126.com', 'phone': '13966672170'}], 'facility': 'The west area of the First Affiliated Hospital of University of Science & Technology China', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Guolin Wu', 'role': 'CONTACT', 'email': 'wgldoctor@sina.com', 'phone': '13855105487'}, {'name': 'Kaiyang Ding', 'role': 'CONTACT', 'email': 'dingkaiy@126.com', 'phone': '13966672170'}], 'overallOfficials': [{'name': 'Guolin Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator associate chief physician'}, {'name': 'Kaiyang Ding', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinobioway Cell Therapy Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}