Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-22 @ 8:54 PM
Study NCT ID:
NCT04782193
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018941', 'term': 'Antigens, CD19'}], 'ancestors': [{'id': 'D015703', 'term': 'Antigens, CD'}, {'id': 'D000943', 'term': 'Antigens, Differentiation'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000944', 'term': 'Antigens, Differentiation, B-Lymphocyte'}, {'id': 'D015778', 'term': 'Minor Histocompatibility Antigens'}, {'id': 'D006649', 'term': 'Histocompatibility Antigens'}, {'id': 'D007519', 'term': 'Isoantigens'}, {'id': 'D015415', 'term': 'Biomarkers'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events that related to treatment', 'timeFrame': '2 years', 'description': "Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)"}, {'measure': 'The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma', 'timeFrame': '6 months', 'description': 'The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline'}], 'secondaryOutcomes': [{'measure': 'Rate of prime CAR-T cells in bone marrow', 'timeFrame': '2 years', 'description': 'Determine the rate of prime CAR-T cells in bone marrow by means of flow cytometry'}, {'measure': 'Rate of prime CAR-T cells in peripheral blood', 'timeFrame': '2 years', 'description': 'Determine the rate of prime CAR-T cells in peripheral blood by means of flow cytometry'}, {'measure': 'Quantity of prime CAR copies in bone marrow', 'timeFrame': '2 years', 'description': 'Determine the quantity of prime CAR copies in bone marrow by qPCR'}, {'measure': 'Quantity of prime CAR copies in peripheral blood', 'timeFrame': '2 years', 'description': 'Determine the quantity of prime CAR copies in peripheral blood by qPCR'}, {'measure': 'Rate of CD19 and CD22 positive cells in Bone marrow', 'timeFrame': '1 years', 'description': 'Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry'}, {'measure': 'Levels of IL-6 in Serum', 'timeFrame': '3 months', 'description': 'Serological determination of IL-6'}, {'measure': 'Levels of IL-10 in Serum', 'timeFrame': '3 months', 'description': 'Serological determination of IL-10'}, {'measure': 'Levels of TNF-α in Serum', 'timeFrame': '3 months', 'description': 'Serological determination of TNF-α'}, {'measure': 'Levels of CRP in Serum', 'timeFrame': '3 months', 'description': 'Serological determination of CRP'}, {'measure': 'Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma', 'timeFrame': '2 years', 'description': 'DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)'}, {'measure': 'Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma', 'timeFrame': '2 years', 'description': 'PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)'}, {'measure': 'Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma', 'timeFrame': '2 years', 'description': 'OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD19', 'CD22', 'CAR-T'], 'conditions': ['B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma', 'detailedDescription': 'Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.\n\nThere are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent\n2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:\n\n 1. Failed to standard chemotherapy regimens;\n 2. Relapse after complete remission, high-risk and / or refractory patients ;\n 3. Relapse after hematopoietic stem cell transplantation;\n3. Evidence for cell membrane CD19 or CD22 expression\n4. All genders ages: 2 to 75 years\n5. The expect time of survive is above 3 months;\n6. KPS\\>60\n7. No serious mental disorders ;\n8. Left ventricular ejection fraction ≥50%\n9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;\n10. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;\n12. With single or venous blood collection standards, and no other cell collection contraindications;\n13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD\n5. The patients treatment by inhibitor of T cell\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.'}, 'identificationModule': {'nctId': 'NCT04782193', 'briefTitle': 'a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chongqing Precision Biotech Co., Ltd'}, 'officialTitle': 'Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'PBC026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prime CAR- T cells', 'description': 'Patients will be be treated with CD19 and CD22 prime CAR- T cells', 'interventionNames': ['Biological: CD19 and CD22 targeted prime CAR- T cells']}], 'interventions': [{'name': 'CD19 and CD22 targeted prime CAR- T cells', 'type': 'BIOLOGICAL', 'description': 'A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously', 'armGroupLabels': ['prime CAR- T cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kunming', 'state': 'Yunnnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sanbin Wang, MD', 'role': 'CONTACT', 'email': 'Sanbin1011@163.com'}, {'name': 'Sanbin Wang, MD', 'role': 'CONTACT'}], 'facility': '920th Hospital of Joint Logistics Support Force', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Zhi Yang, PhD', 'role': 'CONTACT', 'email': 'yangzhi@precision-biotech.com', 'phone': '86-13206140093'}, {'name': 'Sanbin Wang, MD', 'role': 'CONTACT', 'email': 'Sanbin1011@163.com'}], 'overallOfficials': [{'name': 'Sanbin Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China"}, {'name': 'Cheng Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chongqing University Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Precision Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}