Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-03 @ 6:21 AM
Study NCT ID:
NCT03824951
Status:
UNKNOWN
Last Update Posted:
2019-01-31
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Anti-CD19 iCAR NK Cells in Relapsed and 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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of treatment related adverse events as assessed by CTCAE v4.0', 'timeFrame': '1 year', 'description': 'Defined as \\>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 iCAR NK cells in patients with relapsed refractory B cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry\n2. Previously accepted ≥ first-line regimen chemotherapy\n3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation\n4. Over 18 years old and under 70 years old\n5. The expected survival period is more than 3 months.\n6. ECOG≤2\n7. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;\n8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;\n9. The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.\n10. Measurable target lesion\n\nExclusion Criteria:\n\n1. Patients with extramedullary relapse\n2. Burkitt's lymphoma/leukemia\n3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;\n4. Liver and kidney function:\n\n * Total bilirubin \\> 2 x ULN (Gilbert Syndrome \\> 3 x ULN)\n * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 3 × ULN\n * Serum creatinine clearance \\>60 mL/min\n5. Serological examination:\n\n * Absolute neutrophil count (ANC) \\<0.75x109/L\n * Platelet count (PLT) \\<50x109/L\n6. Active hepatitis B (HBV-DNA \\> 1000 copies / mL), hepatitis C, or uncontrolled infection\n7. GVHD ≥ 2 or anti-GVHD treatment\n8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;\n9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks\n10. Active CNS disease (tumor cells in CSF, but \\< 5 WBCs/mL can be included);\n11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation\n12. Creatinine \\> 1.5 times normal upper limit or ALT / AST \\> 3 times normal upper limit or bilirubin \\> 2 times normal upper limit\n13. New York Heart Association (NYHA) graded above or above\n14. Uncontrollable diabetes\n15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining\n16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results"}, 'identificationModule': {'nctId': 'NCT03824951', 'briefTitle': 'Study of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allife Medical Science and Technology Co., Ltd.'}, 'officialTitle': 'An Observational Clinical Study on the Safety and Efficacy of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'CD19 iCAR NK-BJZL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-CD19 iCAR NK Cells', 'interventionNames': ['Biological: Anti-CD19 iCAR NK Cells']}], 'interventions': [{'name': 'Anti-CD19 iCAR NK Cells', 'type': 'BIOLOGICAL', 'description': 'Anti-CD19 iCAR NK Cells injection', 'armGroupLabels': ['Anti-CD19 iCAR NK Cells']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allife Medical Science and Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}