Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
Study NCT ID:
NCT04012892
Status:
UNKNOWN
Last Update Posted:
2019-07-09
First Post:
2019-06-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-07', 'studyFirstSubmitDate': '2019-06-28', 'studyFirstSubmitQcDate': '2019-07-07', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recovery rate of patients being treated with CD19CAR-T', 'timeFrame': '6 months', 'description': 'the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed Non-Hodgkin Lymphoma', 'Refractory Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive\n2. Age 18 to 65 years old, both male and female;\n3. Is expected to survive more than 12 weeks;\n4. Physical condition is good: 0-1 score ECOG score;\n5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;\n6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.\n\nExclusion Criteria:\n\n1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;\n2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;\n3. Pregnancy and lactation women;\n4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;\n5. The Investigator believe the patients should not participate in this experiment."}, 'identificationModule': {'nctId': 'NCT04012892', 'briefTitle': 'Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'HEM-NHL001-CART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10\\^4 cells/kg in 36-96 hours', 'interventionNames': ['Combination Product: CD19 CART']}], 'interventions': [{'name': 'CD19 CART', 'type': 'COMBINATION_PRODUCT', 'description': 'CD19 CART', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518000', 'city': 'Shenzhen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lixing Wang, M.D.', 'role': 'CONTACT', 'email': 'wanglixin1991@sohu.com', 'phone': '86-0755-21839178'}, {'name': 'Li Yu, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lixing Wang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shenzhen University General Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Lixing Wang, MD', 'role': 'CONTACT', 'email': 'wanglixin1991@sohu.com', 'phone': '86-0755-21839178'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen University', 'class': 'OTHER'}, {'name': 'Shenzhen University General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li Yu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}