Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT06464861
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], '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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicity (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'To evaluate the safety and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 2 years', 'description': 'To determine the OS of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'To determine the anti-tumor efficacy of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 2 years', 'description': 'To determine the DOR of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma'}, {'measure': 'Complete response rate (CR)', 'timeFrame': 'Up to 2 years', 'description': 'To determine the CR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma'}, {'measure': 'Partial response rate (PR)', 'timeFrame': 'Up to 2 years', 'description': 'To determine the PR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Mediastinal B-cell Lymphoma (PMBCL)', 'Mantle Cell Lymphoma (MCL)', 'Diffuse Large B Cell Lymphoma( DLBCL)']}, 'descriptionModule': {'briefSummary': 'To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma', 'detailedDescription': 'This is a single-center, open, single-arm clinical exploratory study to observe the safety and efficacy of cord blood derived CD19 CAR-NK cells sequential treatment with 7x19 CAR-T in relapse / refractory B cell lymphoma. This study consisted of two phases: phase I: CARNK cells preparation and infusion (Day0, dose of 2 x 10\\^6 / kg). Phase II: 7x19 CAR-T cells preparation and infusion (Day7, dose 2×10\\^6/kg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75 years old, no gender limit;\n2. Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:\n\n 1. Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ；\n 2. Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;\n 3. Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;\n3. Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;\n4. At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;\n5. The expected survival period is ≥12 weeks;\n6. The puncture section of the tumor tissue was positive for CD19 expression;\n7. ECOG score 0-2 points;\n8. Sufficient organ function reserve:\n\n 1. Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);\n 2. Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;\n 3. Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;\n 4. Glomerular filtration rate\\>50Ml/min\n 5. Cardiac ejection fraction (EF) ≥50%;\n 6. Under natural indoor air environment, basic oxygen saturation\\>92%\n9. Allow a previous stem cell transplantation\n10. The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;\n11. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;\n12. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial\n13. Two tests for the new coronavirus or swine flu virus are negative.\n\nExclusion Criteria:\n\n1. Allergic to any of the components of cell products;\n2. History of other tumors;\n3. Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;\n4. Had received gene therapy within the past 3 months;\n5. Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted;\n6. Patents infected with hepatitis B (HBsAg positive, but HBV-DNA \\< 103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons;\n7. Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association\\'s cardiac function grading criteria;\n8. Patients who received antitumor therapy earlier but did not recover from the toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia);\n9. Subjects with a history of epilepsy or other central nervous system disorders;\n10. Head-enhanced CT or MRI showing evidence of central nervous system lymphoma;\n11. Lactating women who are unwilling to stop breastfeeding;\n12. Any other factors that the investigator believes may increase the risk to the subject or interfere with the test results.'}, 'identificationModule': {'nctId': 'NCT06464861', 'acronym': 'CD19-CARNK/T', 'briefTitle': 'Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed/Refractory B Cell Lymphoma', 'orgStudyIdInfo': {'id': '2024 (0673)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD19-CAR-NK/T', 'description': 'All subjects were intravenously administrated with CAR-NK019 at day 0 with a dose of 2x10\\^6/kg, and after 1 week will be infused with 7x19 CAR-T at the dose of 2x10\\^6/kg', 'interventionNames': ['Biological: CD19-CAR-NK/T']}], 'interventions': [{'name': 'CD19-CAR-NK/T', 'type': 'BIOLOGICAL', 'description': 'Cord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T', 'armGroupLabels': ['CD19-CAR-NK/T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenbin Qian, Professor', 'role': 'CONTACT', 'email': 'qianwb@zju.edu.cn', 'phone': '13605801032'}, {'name': 'Hui Liu, Doctor', 'role': 'CONTACT', 'email': 'sylen@zju.edu.cn'}], 'facility': 'the Second Affiliated Hospital, College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wenbin Qian, Professor', 'role': 'CONTACT', 'email': 'qianwb@zju.edu.cn', 'phone': '+8613605801032'}, {'name': 'Hui Liu, Professor', 'role': 'CONTACT', 'email': 'sylen@zju.edu.cn', 'phone': '13819198629'}], 'overallOfficials': [{'name': 'Wenbin Wenbin, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}