Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 5:17 AM
Study NCT ID:
NCT06707259
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-24', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicity (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'To evaluate the safety, and tolerability, and determine the recommended dosage of cord blood-derived Anti-CD19 IL10/IL15-CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma'}], 'secondaryOutcomes': [{'measure': 'Complete response rate (CR)', 'timeFrame': 'Up to 2 years', 'description': 'To determine the anti-tumor effectivity of CB IL-10-CD19-CAR NK'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Partial response rate (PR)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Non Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "To study the safety and effectiveness of cord blood-derived IL-10/IL-15 CD19-CAR NK in patients with B-cell non-Hodgkin's lymphoma", 'detailedDescription': 'This is an open, single-arm, single-dose, dose-escalation clinical trial designed to evaluate the safety and the preliminary efficacy of CB IL-10/IL-15 CD19-CAR NK cells. 6-24 patients are planned to be enrolled in the dose-escalation trial (2×10\\^6 cells/kg,4×10\\^6 cells/kg, 8×10\\^6 cells/kg). Based on the results in the dose-escalation trial, the recommended dose will be determined. Another 30 patients will be enrolled in the dose-expansion trial. The primary endpoints are DLT and MTD; the second is the overall response rates (CR and PR), survival, and progression-free survival. Patients will be infused on day 0, day 3, and day 6， respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Volunteer to participate in this study and sign an informed consent form;\n2. Age 18-75 years old, no gender limit;\n3. 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:(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 ； (2) Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; (3) Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; (4) 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; 7, ECOG score 0-2 points;\n7. Sufficient organ function reserve: (1) Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); (2) Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min; (3) Serum total bilirubin and alkaline phosphatase ≤1.5× UNL; （4）Glomerular filtration rate\\>50Ml/min Cardiac ejection fraction (EF) ≥50%; (5) Under natural indoor air environment, basic oxygen saturation\\>92% .\n8. Allow a previous stem cell transplantation.\n9. 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;\n10. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;\n11. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial.\n12. Two tests for the new coronavirus were negative.\n\nExclusion Criteria:\n\n1. Those who have a history of allergies to any of the ingredients in cell products;\n2. History of other tumors;\n3. Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;\n4. Have received gene therapy in the past 3 months;\n5. Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;\n6. Hepatitis B (HBsAg positive, but HBV-DNA \\<103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including but not limited to people living with HIV;\n7. According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV impaired subjects;\n8. Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);\n9. Subjects with a history of epilepsy or other central nervous system diseases; 10. Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;\n\n11\\. Have any other drugs that target CD19; 12. Women who are breastfeeding and unwilling to stop breastfeeding; 13. Any other situation that the investigator believes may increase the subject's risk or interfere with the test results."}, 'identificationModule': {'nctId': 'NCT06707259', 'briefTitle': 'Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL', 'orgStudyIdInfo': {'id': '2024（1369）'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CB IL-10/IL-15-CD19-CAR NK', 'description': 'All subjects were intravenously administrated with IL-10/IL-15 CD19-CAR NK', 'interventionNames': ['Biological: anti-CD19 IL10/IL15 CAR-NK']}], 'interventions': [{'name': 'anti-CD19 IL10/IL15 CAR-NK', 'type': 'BIOLOGICAL', 'description': 'Lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19-IL10/IL-15 CAR', 'armGroupLabels': ['CB IL-10/IL-15-CD19-CAR NK']}]}, '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', 'phone': '13819198629'}], '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, Doctor', 'role': 'CONTACT', 'email': 'sylen@zju.edu.cn', 'phone': '13819198629'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}