Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-01 @ 4:45 AM
Study NCT ID:
NCT07002112
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)', 'timeFrame': 'Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.'}, {'measure': 'Pharmacokinetics in peripheral blood', 'timeFrame': 'Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec100 infusion.'}, {'measure': 'Pharmacokinetics in bone marrow', 'timeFrame': 'Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec100 infusion.'}, {'measure': 'The recommended Phase II dose (RP2D) for this cell therapy', 'timeFrame': '30 days after LVIVO-TaVec100 infusion', 'description': 'RP2D established through 3+3 design and the DLTs occurring following LVIVO-TaVec100 infusion'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LVIVO-TaVec100 cell infusion'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LVIVO-TaVec100 to the first documented disease progression or death, whichever occurs first'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'Overall Survival (OS) is defined as the time from the date of first infusion of LVIVO-TaVec100 to death of the subject'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'Time to Response (TTR) is defined as the time from the date of first infusion of LVIVO-TaVec100 to the date of the first response evaluation of the subject who has met all criteria for CR or PR'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders'}, {'measure': 'Immunogenicity assessment of LVIVO-TaVec100 infusion', 'timeFrame': 'Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)', 'description': 'The incidence of Anti- LVIVO-TaVec100 antibody in patients who received LVIVO-TaVec100 infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory B-cell Malignancies']}, 'descriptionModule': {'briefSummary': 'A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec100 product in the Treatment of Relapsed/Refractory B-cell Malignancies.', 'detailedDescription': 'This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LVIVO-TaVec100 product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of LVIVO-TaVec100 product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.\n2. Aged 18-65 years (inclusive).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. At least one evaluable tumor lesion.\n5. Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications\n6. Life expectancy≥ 3 months\n7. Clinical laboratory values meet screening visit criteria\n8. Adequate organ function;\n\nExclusion Criteria:\n\nSubject eligible for this study must not meet any of the following criteria:\n\n1. Prior antitumor therapy with insufficient washout period ;\n2. Prior treatment with other autologous cells or gene therapies other than targeting CD19 autologous CAR-T;\n3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).\n4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).\n5. Lactating women;"}, 'identificationModule': {'nctId': 'NCT07002112', 'briefTitle': 'The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies', 'orgStudyIdInfo': {'id': 'LB2409-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LVIVO-TaVec100 product', 'description': 'Each subject will be given a single-dose LVIVO-TaVec100 product infusion at each dose level.', 'interventionNames': ['Biological: LVIVO-TaVec100 product']}], 'interventions': [{'name': 'LVIVO-TaVec100 product', 'type': 'BIOLOGICAL', 'description': 'Prior to infusion of the LVIVO-TaVec100 product, subjects will receive bridging therapy if needed.', 'armGroupLabels': ['LVIVO-TaVec100 product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kaiyang DING', 'role': 'CONTACT', 'email': 'dingkaiy@126.com', 'phone': '13966672170', 'phoneExt': '+86'}, {'name': 'Kaiyang DING', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of USTC west district', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '102206', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yajing ZHANG', 'role': 'CONTACT', 'email': '23975701@qq.com', 'phone': '18601333856', 'phoneExt': '+86'}, {'name': 'Yajing ZHANG', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Gobroad Boren Hospita', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haisheng LIU', 'role': 'CONTACT', 'email': 'liuhs78299@163.com', 'phone': '13933078299', 'phoneExt': '+86'}, {'name': 'Haisheng LIU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Zhang', 'role': 'CONTACT', 'email': 'yizhang001@163.com', 'phone': '15138928971', 'phoneExt': '+86'}, {'name': 'Yi Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of ZHENGZHOU University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Heng MEI', 'role': 'CONTACT', 'email': 'mayheng@126.com', 'phone': '13886160811', 'phoneExt': '+86'}, {'name': 'Heng MEI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Union Hospital Tongji Medical College Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei FAN', 'role': 'CONTACT', 'email': 'fanlei3014@126.com', 'phone': '13813976136', 'phoneExt': '+186'}, {'name': 'Lei FAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'FAN Lei', 'role': 'CONTACT', 'email': 'fanlei3014@126.com', 'phone': '13813976136', 'phoneExt': '+86'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Legend Biotech Co.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of lymphoma center', 'investigatorFullName': 'Lei Fan', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}