Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-09 @ 8:37 AM
Study NCT ID:
NCT03312205
Status:
UNKNOWN
Last Update Posted:
2019-01-09
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2023-08-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-10-12', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor load', 'timeFrame': 'Up to 24 months', 'description': 'Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.'}], 'secondaryOutcomes': [{'measure': 'CAR-T cell persistence', 'timeFrame': 'Up to 24 months', 'description': 'CAR-T cell persistence will be quantified with flow cytometry and qPCR'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia', 'Lymphoma', 'Multiple Myeloma of Bone (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 50 patients are planned to be enrolled over a period of 2 years.', 'detailedDescription': 'Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA, CLL-1, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:\n2. ECOG scoreā¤2;\n3. To be aged 1 to 70 years;\n4. More than a month lifetime from the consent signing date.\n\nExclusion Criteria:\n\n1. Serious cardiac insufficiency, left ventricular ejection fraction\\<50%;\n2. Has a history of severe pulmonary function damaging;\n3. Merging other progressing malignant tumor;\n4. Merging uncontrolled infection;\n5. Merging the metabolic diseases (except diabetes);\n6. Merging severe autoimmune diseases or immunodeficiency disease;\n7. Patients with active hepatitis B or hepatitis C;\n8. Patients with HIV infection;\n9. Has a history of serious allergies on Biological products (including antibiotics);\n10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;\n11. Pregnancy or lactation women;\n12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation."}, 'identificationModule': {'nctId': 'NCT03312205', 'briefTitle': 'CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hebei Senlang Biotechnology Inc., Ltd.'}, 'officialTitle': 'CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies', 'orgStudyIdInfo': {'id': 'daopeicart'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous CAR-T cells', 'description': 'Patients will be be treated with autologous CAR-T cells', 'interventionNames': ['Biological: Autologous CAR-T cells']}], 'interventions': [{'name': 'Autologous CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.', 'armGroupLabels': ['Autologous CAR-T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '065000', 'city': 'Langfang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peihua Lu, PhD & MD', 'role': 'CONTACT', 'email': 'peihua_lu@126.com', 'phone': '008618611636172'}, {'name': 'Peihua Lu, PhD & MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jianqiang Li, PhD & MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hebei Yanda Ludaopei Hospital', 'geoPoint': {'lat': 39.52079, 'lon': 116.71471}}], 'centralContacts': [{'name': 'Peihua Lu, PhD & MD', 'role': 'CONTACT', 'email': 'peihua_lu@126.com', 'phone': '18611636172'}, {'name': 'Jianqiang Li, PhD & MD', 'role': 'CONTACT', 'email': 'limmune@gmail.com', 'phone': '008615511369555'}], 'overallOfficials': [{'name': 'Peggy Lu, PhD & MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hebei Yanda Ludaopei Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Senlang Biotechnology Inc., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hebei Yanda Ludaopei Hospital', 'class': 'OTHER'}, {'name': 'Beijing Lu Daopei Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}